R&D Manager-Perm-PA location

Must be able to work 100% onsite (relocation assistance provided)

Occasional traveling, must have IP experience, hands-on lab experience, small molecules experience preferred, no biological, small pharma preferred, Must have PhD

Job Summary

Responsible for leading the successful commercialization of our Research and Development work product(s) resulting in the expansion of the company’s commercial portfolio while generating revenues and leading to sustainable year over year growth.

Essential Functions

•Conducts technical research and analysis on specific therapeutic markets to create detailed business plans for commercial opportunities that drive R&D activities that can meet company goals and growth objectives. 

•Maintains up-to-date knowledge of our products and services, as well as industry trends, regulatory framework, and competitors.

•Assesses competitive landscape and advises the business as to the degree of competitors sophistication by which their technology can compete.

•Performs all technical due diligence evaluations for new opportunities in partnership with the sales and business development functions. Recommends a go or no-go decision and effectively communicates confidence and risk.

•Collaborates with other departments to ensure alignment and support of commercialization efforts.

•Participates in annual and long-range business planning; develops technical and intellectual property strategies consistent with overall business strategy; effectively positions the business for sustainable and profitable commercial revenue streams.

•Establishes and administers procedures pertaining to discovery of new technologies, based upon market feedback and unmet drug delivery needs.

•Demonstrated competency in technical transfer from lab to process-scale.

•Leads business in formulation and implementation of intellectual property strategy yielding significant competitive advantage; monitors and leads the business in effectively understanding relevant intellectual property landscape; maintains adequate records to support intellectual property-related actions; assists Patent Counsel in obtaining patent protection and assuring freedom to operate.

•Forecasts operating and capital expense requirements and manages budgets.

•Maintains current awareness of pharmaceutical and drug delivery technical progress via avenues including, but not limited to:

  Industry peer networking

  Monitoring relevant literature

  Participating in industry groups

  Attending relevant conference

•Prepares technical literature in the form of research papers, technical journal submissions, and poster presentations in support of marketing effort.

•Presents non-confidential technical information at conferences and symposiums.

•Effectively communicates functional status within function as well as across division.

•Conducts all aspects of position in a professional, respectful manner consistent with our Guiding Principles; embraces 6S LEAN culture; organizes personal work areas and appearance consistent with corporate and divisional professional image.

•Prepares and presents reports, analyses, and other pertinent data/information to peers, clients, and/or management.

•Manage and organize time, information, and resources effectively to meet deadlines and respond to requests on a timely basis.

•Proven communication skills (verbal and written) with an ability to establish relationships and collaborate with a diverse set of stakeholders at various levels internally & externally.

Additional Responsibilities:

•Performs other duties and responsibilities as assigned.

Job Specifications:

•Advanced degree (PhD or Master’s) in a scientific and/or engineering discipline focused in chemistry, pharmaceutical sciences, biology, biotechnology, or related area preferred.

•Experienced with FDA-regulated business and requirements necessary to operate in compliance with FDA 21 CFR 211 regulations: familiarity with all stages of pre-clinical and clinical therapeutic offering development.

•Knowledgeable in DEA regulations concerning controlled substances (e.g., Schedules II-V).

•5+ years technical selling in pharmaceutical and/or drug-delivery business; preferably experienced with transdermal, transmucosal, and/or oral thin film applications.

•In-depth understanding of market research methods and analysis.

•Extremely driven individual with high expectations of themselves and those around them.

•Solid knowledge of performance reporting and financial/budgeting processes.

•Commercial awareness partnered with a strategic mindset.

•Strong leadership, influencing, interpersonal, negotiation, communication, and organization skills.

•Assist in setting financial targets and budget development and monitoring.

•Proficiency with standard desktop computer software applications.

•Ability to travel up to 35% of the time (including some international).

offering a very competitive base salary plus bonus, comprehensive benefits package, plus relocation assistance

If interested, send your updated resume with contact info to vince@techedgerecruiting.com

Unfortunately Visa sponsorship or transfer not available for this role

Business Development Manager-Perm-PA location

Must be able to work 100% onsite (relocation assistance provided), Must have pharmaceutical experience, Sales/ client facing, small molecules experience preferred

Job Summary

Responsible for developing and implementing our Division Business Development function to achieve our financial goals and growth targets.

Essential Functions:

•Represents the company in a professional manner and with the utmost integrity.

•Develops extensive network of potential clients and works to identify, evaluate & prioritize potential opportunities.

•Leads our Market Backed strategy development process.

•Outlines and executes our future technology, strategic and sales growth roadmap.

•Actively secures JV partnerships and strategic commercial partnerships to grow topline sales.

•Manages key strategic commercial opportunities prior to Stage One in the Stage Gate process and then turn over to Sales.

•Works in attaining new work plans for company.

•Attend 8-10 conferences annually and/or tradeshows to secure partnerships/key growth opportunities.

•Responsible for all aspects of key customer engagement; orchestrates generation and maintenance of contact at all levels utilizing other members of the organization as appropriate.

•Works with customers and our functional counterparts to develop design input for new projects; coordinates customer interactions and communications. 

•Organizes customer information in frameworks which readily afford business organizational efficiency.

•Assembles and communicates accurate period and annual forecasts at frequency specified by company; works with functional counterparts to ensure customer requirements are understood and satisfied.

•Meets or exceeds revenue goals; regularly monitors key metrics and communicates status versus goals; identifies and implements improvement actions as warranted.

•Formulates and manages pricing strategy to optimize realization of value for our product offerings and capabilities.

•Negotiates customer contracts and supply agreements ensuring clear expectations for all parties and ensuring company’s interests are adequately served.

•Participates in annual and long-range business planning; develops market and opportunity penetration strategies consistent with meeting or exceeding the revenue and profit objectives; effectively positions the business for sustainable and profitable commercial revenue growth.

•Effectively communicates business status within functions as well as across division.

•Conducts all aspects of position in a professional, respectful manner consistent with our Guiding Principles; embraces 6S LEAN culture; organizes personal work areas and appearance consistent with corporate and divisional professional image.

•Presents at tradeshows/conferences (technical papers, market trends, best practices, etc.

Job Specifications:

•Bachelor’s degree in a scientific, engineering or business discipline preferably coupled with a Masters in Business Administration.

•Experienced with FDA-regulated business and requirements necessary to operate in compliance with FDA 21 CFR 211 regulations; familiarity with all stages of pre-clinical and clinical therapeutic offering development.

•Experienced with DEA regulations for handling controlled substances (e.g. Schedules II-V).

•5+ years Business Development and sales experience in a pharmaceutical and/or drug-delivery business.  Preferably experienced with transdermal and oral thin film applications.

•Ability to analyze market landscape and then formulate and implement strategies to penetrate opportunities consistent with company capabilities.

•Excellent networking, relationship-building, selling and customer management skills.

•Experience negotiating JV partnerships and key customer agreements/contracts.

•Work 100% onsite.

•Strong leadership, influencing, interpersonal, negotiation and communication skills.

•Ability to lead and participate in cross-functional teams to develop new products and processes and to interact with customers to define customer requirements during the design-input phase of the product development process.

•Proficiency with standard desktop computer software applications.

•Ability to travel >50% of the time (including some international).

offering a very competitive base salary plus bonus, comprehensive benefits package, plus relocation assistance

If interested, send your updated resume with contact info to vince@techedgerecruiting.com

Unfortunately Visa sponsorship or transfer not available for this role

Sr. Mgr., Business Development-Perm-remote based

The Sr. Manager, Business Development is responsible for expanding our market reach by driving growth and partnerships, particularly within wholesale clubs, national fleet/large equipment, power sports, and auto dealerships. The Sr. Manager, Business Development collaborates with the sales team, customer support, and other departments to ensure alignment with production, marketing, and distribution strategies.

Duties/Responsibilities

·Manage and lead the business development team, including hiring, training, mentoring, and evaluating staff

·Identify and evaluate new business opportunities within the wholesale clubs, national fleet/large equipment, power sports, auto dealership sectors, and other appropriate channels.

·Develop and execute strategies to expand market share and drive revenue growth.

·Create and implement targeted sales programs specifically tailored to specified sectors.

·Cultivate and maintain strong relationships with key clients and be the main point of contact for client inquiries, concerns, and negotiations.

·Conduct market research and analysis to identify trends, competitive landscape, and opportunities for growth within designated sectors.

·Monitor industry development and changes to stay ahead of market dynamics.

·Develop accurate sales forecasts and track performance against targets.

·Prepare regular reports for management, providing insights into market trends and sales performance.

·Lead negotiations with key clients to secure advantageous agreements.

·Work closely with legal and finance teams to ensure contract compliance.

·Foster a culture consistent with our companie’s purpose, core values and strategic anchors.

·Regular attendance is an essential function of the job.

·Other duties as assigned.

Required Skills/Abilities

·Excellent communication and interpersonal skills, with the ability to build rapport and maintain long-term relationships with clients.

·Customer-focused approach, with the ability to understand and address customer needs effectively.

· Excellent negotiation and persuasion skills, with the ability to close deals and upsell existing clients.

·Strong business acumen, with the ability to understand clients’ industries and business objectives.

·Strong understanding of the consumer goods manufacturing industry and the specified sectors.

·Analytical mindset with the ability to gather and interpret market data.

·Proven track record of successfully navigating complex sales channels.

·Results-oriented mindset with a proactive approach to achieving sales goals.

·Adaptability and resilience in a fast-paced sales environment.

·Willingness to travel to client meetings and industry events as required.

Qualifications

·Education: bachelor’s degree in business, marketing, or a related field.

·Experience: 7+ years’ proven experience in business development, with a track record of achieving sales targets and customer retention within the wholesale clubs, national fleet/large equipment, power sports, auto dealership sectors, or other appropriate channels, including 3+ years’ experience directly managing staff.

·Internal applicants: 6+ months successful demonstration of current position responsibilities, approval from current manager, and a relevant combination of education, continuing education, and experience.

·Candidates who do not meet the specified educational or experience requirements but possess equivalent qualifications and relevant experience may be considered for this position. The company will assess candidates on a case-by-case basis to determine their suitability for the role based on their overall qualifications, skills, and demonstrated capabilities. The decision to consider education and experience equivalencies will be at the sole discretion of the hiring team and will comply with applicable laws and regulations.

 This is a summary of the primary accountabilities and requirements for this position. The company reserves the right to modify or amend accountabilities and requirements at any time at its sole discretion based on business needs. Any part of this job description is subject to possible modification to reasonably accommodate individuals with disabilities. Equal Opportunity employer/Veterans/Disabled

If interested, please send updated resume to vince@techedgerecruiting.com and you will be contacted immediately.

Unfortunately Visa sponsorship or transfer not available for this role.

very competitive base salary plus 15% bonus, comprehensive benefits package

Director, Quality Assurance-Perm-Ohio location

The Director, Quality Assurance will be a key member of the Leadership team with responsibility for establishing and administering all Quality functions related to cGXX (cGMP, QSR and cGTP) operations. The Director, Quality Assurance will provide quality oversight and support our manufacturing, processing, testing and product distribution functions. The position requires domestic and international travel, primarily to our locations to ensure compliance with domestic and international regulations. 

Requirements of the Director, Quality Assurance

BA, MS or PhD with at least 10 years’ experience in a quality assurance or related role.

Demonstrated knowledge of cGXXs and relevant regulatory guidelines, both in the US and OUS.

Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.

Experience at all phases of development, including commercialization.

Experience in leading external regulatory audits

Demonstrate experience of successful hiring and management of a quality or related organization / group.

Excellent oral and written communication skills

Excellent interpersonal and team building skills

Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve

Ability to exercise creativity and judgment

Experience with human tissue products or implantable medical devices desirable

Experience with quality functions for biologics desirable

Experience with Six Sigma and/or Lean Manufacturing desirable

Familiar with preparation of and guidelines for Chemistry, Manufacturing and Controls (Module 3) worldwide regulatory submissions desirable. 

Responsibilities of the Director, Quality Assurance

The specific duties of the Director, Quality Assurance include but are not limited to:

Establishes and administers our Quality Management System

Oversees all quality functions related to human tissue products, biologic products and medical devices.

Ensures compliance with relevant domestic and international quality requirements

Provides guidance on and administer process validation activities

Performs risk assessments and leads investigations to address quality issues

Performs release and disposition functions; manages and controls cGXX-manufactured intermediates and products; works with Operations, Clinical and Translation Science staff as required

Represents us during external audits and inspections and ensures pre-approval inspection readiness

Participates in vendor selection, assessment and qualification

Works with internal and external technical teams (process, analytical, formulation development, quality control)

Recruits, develops, and manages the Quality Assurance department as the company’s pipeline and development activities grow

Develops budget for Quality Assurance department

A dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.

As a key and senior member of our Leadership team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.

Other duties as assigned

Experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others.

Physical Requirements

The work is sedentary work which requires exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following physical abilities: mental acuity, visual acuity, walking, repetitive motion, speaking, talking, hearing, and typing.   

Working & Environmental Conditions

Work involves everyday risks or discomforts which require normal safety precautions typical of such places as offices or meeting and training rooms, e.g., use of safe workplace practices with office equipment, avoidance of trips and falls, and observance of fire and building safety regulations. 

Benefits/Compensation

This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

If interested, please send your updated resume with contact info to vince@techedgerecruiting.com and you will get an immediate response.

Offering a very Competitive Base salary plus bonus/401K and comprehensive benefits package

Unfortunately Visa sponsorship or transfer not available for this role.

Business Development Executive-Perm-West Coast-remote-based

Offering a very competitive base salary plus uncapped bonus, comprehensive benefits package.

Company Offerings

•CGMP Manufacturing for API and HPAPI

•Process Development and Scale-up

•Solid State Chemistry and Micronization

•Analytical Method Development and Validation

•Impurity Isolation, Characterization, and Reference Qualification

•Stability Storage and Product Testing

This role will report to the Director of Business Development and will support activities related to strategic business development in the West Coast Territory.

Essential Duties & Responsibilities

•Develop new business for CGMP Manufacturing and associated Pharma Services to achieve Sales Order Target objectives in territory.

•Perform sales role by prospecting, communicating with clients, negotiating, and closing opportunities.

•Structure and negotiate contracts and proposals with an eye toward detail.

•Maintain relationships with existing client base to develop and close repeat business opportunities.

•Recognize client needs

•Design Custom Synthesis and Services Sales plans for territory and execute with reporting into CRM

•Interact and effectively communicate with all departments at Regis

•Match prospective opportunities that are “good fits” for Regis’ capabilities and resources

•Qualify opportunities, scope RFPs, review proposals

•Represent Regis to clients in a positive and professional manner

Qualifications

•A science degree (B.S. or higher) is required, with a focus in any of the following fields: Chemistry, Biology, Biochemistry, or other relevant life sciences field.

•A minimum of five (5) years of sales/business development experience in contract manufacturing or chemical synthesis is highly preferred.

•Comprehension of CGMP, phases of drug development, FDA requirements

•Analytical and strategic thinker possessing a sense of appropriateness and business acumen.

•Prolific networker with strong existing business development connections within biotech companies.

•Superior communicator with effective strategies for addressing various audiences.

•Project management skill, attention to detail and ability to follow-through on multiple projects.

•Collaborative, transparent and ability to foster teamwork.

•Deliver quality results under pressure in a dynamic environment within tight time constraints.

•Strong MS Excel and PowerPoint skills.

•Willingness to travel up to 50% to various networking events, conferences, and target/partner sites.

•Must reside within the territory with a strong preference for the West Coast( San Franscisco ) Area.

If interested, send updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.

Unfortunately, Visa sponsorship or transfer not available for this role.

Supply Chain Manager-Dallas-Perm-CPG Mfg.

How much Travel-5%

Five years of experience would be ideal.

Needs to have worked in a CPG manufacturing company previously with a solid understanding of the various metrics that go into CPG manufacturing.

Will be the tactical project manager on sales programs as it relates to the supply chain portion of the program.

Must have a working knowledge of material planning, modeling, inventory management, excel, and BI tools.

A certification in APICS, APIM, CSCP or working toward that would be a plus.

The interview process would be an HR interview, HM interview, CEO interview.

Supply Chain Manager

The Supply Chain Manager is responsible for establishing and managing key processes in inventory planning, warehouse operations, and logistics related to finished goods. This position works with 3PL partners in coordinating activities and monitoring metrics for warehouse and logistics operations with a focus on coordination of material movement to support global distribution processes.

Duties/Responsibilities

·Develop and implement supply chain strategies, policies, and procedures to meet business objectives.

·Establish and maintain stratification and ranking of finished good sku’s.

·Oversee and coordinate end-to-end supply chain operations with focus on production planning, inventory management, logistics and distribution.

·Assist in defining and implementing planning processes for each of the determined categories of finished goods.

·Collaborate with manufacturing facilities, sourcing teams, and demand planners to track and manage changes in demand for products.

·Oversee the implementation and utilization of supply chain management software and tools.

·Monitor and analyze supply chain performance metrics, identifying areas for improvement and implementing corrective actions.

·Optimize supply chain processes to reduce lead times, minimize costs, and improve overall efficiency.

·Implement inventory management strategies to balance inventory levels while meeting customer demand.

·Develop processes to support global distribution processes for European and other international entities.

·Anticipate supply chain risks, such as disruptions in supply or changes in demand, through proactive planning and contingency measure.

·Collaborate with other departments, such as sales, production, logistics, and finance, to optimize supply chain performance and meet customer requirements.

·Perform responsibilities in a manner consistent with Schumacher’s purpose, core values and strategic anchors.

·Regular attendance is an essential function of the job.

·Other duties as assigned.

Required Skills/Abilities

·Strong leadership and team management skills, with the ability to mentor and motivate supply chain teams.

·Strong interpersonal and influence skills to cultivate relationships, facilitate negotations, and build strong partnerships.

·Demonstrated success in developing and implementing supply chain strategies that drive efficiency and cost savings.

·Proven ability to work collaboratively with cross-functional teams and stakeholders.

·Knowledge of industry regulations and compliance requirements related to the supply chain.

·Strong project management and organizational skills to manage multiple supply chain initiatives.

·Familiarity with demand forecasting and production planning.

·Operational knowledge of Microsoft Tools with an advanced level of knowledge with Excel.

·Experience with Power BI, Tableau, or other business intelligence system.

Qualifications

·Education: bachelor’s degree in supply chain management, business administration, finance, or related field.

·Experience: 5+ years’ proven experience managing supply chain operations within a manufacturing or distribution environment.

·Internal applicants: 6+ months successful demonstration of current position responsibilities, approval from current manager, and a relevant combination of education, continuing education, and experience.

·Candidates who do not meet the specified educational or experience requirements but possess equivalent qualifications and relevant experience may be considered for this position. The company will assess candidates on a case-by-case basis to determine their suitability for the role based on their overall qualifications, skills, and demonstrated capabilities. The decision to consider education and experience equivalencies will be at the sole discretion of the hiring team and will comply with applicable laws and regulations.

This is a summary of the primary accountabilities and requirements for this position. The company reserves the right to modify or amend accountabilities and requirements at any time at its sole discretion based on business needs. Any part of this job description is subject to possible modification to reasonably accommodate individuals with disabilities. Equal Opportunity employer/Veterans/Disabled

Offering a very competitive base salary plus bonus and comprehensive benefits package

If interested, please send updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately

Unfortunately Visa Sposorship or Transfer not available for this role

Packaging Sourcing Manager-Perm-Dallas, TX

This is a new position. The position is hybrid and the office is near DFW airport. 

Job Description – Packaging Sourcing Manager

The Packaging Sourcing Manager is responsible for developing and executing sourcing strategies to optimize our supply chain, enhance cost efficiency, and ensure high-quality sustainable solutions. This includes identifying, evaluating, and managing suppliers for packaging materials.

Duties/Responsibilities

Develop and implement comprehensive sourcing strategies for packaging materials, including containers, labels, cartons, and other relevant components.

Analyze market trends, supplier capabilities, and cost drivers to identify opportunities for cost savings and quality improvement.

Identify, evaluate, and manage supplier relationships, ensuring a reliable and diverse supply chain.

Conduct supplier audits and evaluations to ensure compliance with quality standards and sustainability requirements.

Negotiate pricing, contracts, and terms with suppliers to secure favorable agreements while maintaining quality standards.

Monitor and analyze packaging material costs and trends, conducting regular cost-benefit analyses to identify cost-saving opportunities.

Collaborate with suppliers and cross-functional teams (production, supply chain, R&D, and marketing) to develop innovative packaging materials that meet product specifications and sustainability goals in line with business objectives while maintaining both aesthetics and functional product requirements.

Balance sourcing needs for regular production as well as quick-turn sample/prototype needs for NPD projects.

Proactively communicate potential supply chain disruptions, quality issues, and production needs.

Establish and maintain packaging material specifications and designs that comply with relevant labeling and regulatory requirements.

Monitor and address any packaging quality issues or non-conformities.

Ensure that packaging material meets regulatory and compliance requirements, including sustainability and environmental considerations.

Identify potential risks in the supply chain related to packaging materials and develop

mitigation strategies.

Utilize data analysis tools and systems to track and report key performance indicators (KPIs) related to packaging sourcing.

Perform responsibilities in a manner consistent with Schumacher’s purpose, core values and strategic anchors.

Regular attendance is an essential function of the job. Other duties as assigned.

Required Skills/Abilities

In-depth knowledge of packaging materials, technologies, and industry trends.

Strong negotiation and contract management skills.

Analytical mindset with proficiency in data analysis tools and Excel.

Excellent communication and interpersonal skills for effective collaboration with cross-

functional teams and suppliers.

Problem-solving and decision-making abilities to address complex sourcing challenges.

Familiarity with regulatory requirements and sustainability initiatives in packaging sourcing.

Knowledge of ISTA and Amazon Frustration-Free Packaging Program Certifications.

Ability to manage multiple projects and priorities in a fast-paced environment.

Qualifications

Education: bachelor’s degree in supply chain management, business administration, industrial design, or related field.

Experience: 5+ years’ proven experience managing sourcing strategies within a manufacturing environment, with a focus on packaging materials within the consumer-packaged goods industry.

Internal applicants: 6+ months successful demonstration of current positionresponsibilities, approval from current manager, and a relevant combination of education, continuing education, and experience.

Candidates who do not meet the specified educational or experience requirements but possess equivalent qualifications and relevant experience may be considered for this position. The company will assess candidates on a case-by-case basis to determine their suitability for the role based on their overall qualifications, skills, and demonstrated capabilities. The decision to consider education and experience equivalencies will be at the sole discretion of the hiring team and will comply with applicable laws and regulations.

Unfortunately, Visa sponsorship or transfer not available for this role

Very competitive base salary, plus 10% bonus, plus comprehensive benefits package

If interested, and more importantly qualified, please send your updated resume with contact info to vince@techedgerecruiting.com

ARx Director of Business Development-Perm-PA location

Summary

Responsible for the generation of new business, project and customers, including all sales activities, from lead generation through closing of business in an assigned territory. Develops and implements sales strategy to achieve the target goals in our strategic plan, specifically regarding number of accounts contacted, visited, new opportunities entered, and new projects entered meeting target revenue requirements.

Essential Functions:

Generates new revenue growth for us by expanding the number of work plans with new and existing customers. Responsibilities include:

· Effectively prospects new contacts at multiple levels in multiple functions including formulation development, clinical development, and lifecycle management at top global pharmaceutical companies and specialty pharmaceutical companies in order to generate new work plans.

· Meet or exceed financial sales goals.

· Develops a database (Sugar) of qualified leads through referrals, telephone canvassing, trade show prospecting, direct mail, email, and networking, documented in Customer Relationship Management database.

· Coordinates initial meeting with prospective customers, which may include travel. Lead meeting strategy with delivery of company presentation and capabilities.

· Identifies and evaluates potential opportunities with prospect, determining if project and prospect is a strategic fit with our business objective.

· Performs initial project due diligence analysis with a key understanding of market and customer unmet needs and our value proposition. Provides project forecast and financial to management.

· Generating scope of work, budget and key contractual terms according to our business model for internal review by functional Directors utilizing due diligence work. Assist Director of Marketing and Business Development in final negotiations to secure desired business opportunities.

· Applies and shares a comprehensive understanding of and expertise in our drug delivery systems and drug product development and manufacturing services, as well as customer needs in pharmaceutical development.

· Sells consultatively and makes recommendations to prospects and customers of the various solutions we can offer to solve their business issues.

· Maintains accurate records of all sales and prospecting activities including sales calls, presentations, forecast, opportunity info, closed sales, and follow-up activities within their assigned territory, including the use of Sugar to maintain accurate records to maximize territory potential.

· Develops and executes portion of Strategic Plan in partnership with Director of Marketing and Business Development for assigned territory assuring new revenue growth.

· Provide market feedback to Director of Marketing and Business Development for the development of new drug delivery technologies.

· Conducts self and executes all responsibilities in a professional and effective manner consistent with Company Guiding Principles

Additional Responsibilities:

· Contributes to the annual strategic planning process as requested.

· Maintains contact with all customers in the market area to ensure high levels of customer satisfaction.

· Demonstrates ability to interact and cooperate with all company associates.

· Build trust, value others, communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity.

· Follows all cGMP requirements and procedures specified for the position.

· Works with other functional units to ensure identification of and compliance with best practices across sales and business functions.

· Applies company policies, ensures good housekeeping, and enforces safety regulations.

· Performs other duties and responsibilities as assigned.

Job Specifications

· > 5 years of consultative selling or customer facing pharmaceutical project management, engineering or R&D experience

· BA/BS degree required.

· Willingness to travel and work with a global team of professionals.

· Strong listening, written and oral communication skills and presentation skills.

· Ability to think strategically and work in a team environment.

· Proven track record of entering and closing new project opportunities, generating new sales revenue and ability to attain sales goals.

· Seek to have a positive impact on the business with a strong drive for results.

· Strong understanding of customer and market dynamics and requirements.

· Excellent project management and organizational skills.

· Ability to work cross functionally and influence without authority.

· Ability to maintain confidentiality of customer, company, and products.

· Functioning capability with standard office software (word processing, spreadsheet, etc.).

· Basic knowledge in negotiating confidentiality, master services, or developmental/supply agreements.

Physical Demands

Ability to travel 50 %+ of the time.

Location

Flexible in the Mid-Atlantic area, close to a major airport

Must Haves

Must be fully vaccinated against covid-19 (no exceptions)

Must be able to travel at least twice a month (for 2 days typically each time) to Glen Rock, PA

Must have pharmaceutical experience

Must have drug development experience in the sales dept. (not looking for someone that has sold product to hospitals, clinics, etc. Someone that has worked with other pharmaceuticals in order to develop their product, so the product it still not fully developed. Technology or Dosage Form development services experience ideal).

Offering a competitive Base Salary, plus Bonus, comprehensive benefits, and relocation if needed.

Unfortunately, Visa sponsorship or traansfer not available for this role.

If interested and qualified, please send updated resume with contaact info to vince@techedgerecruiting.com and you will be contacted immediately.

Regulatory Affairs Manager-Perm

Located in Tampa, FL, Alachua, FL, or Vandalia, OH!

The Regulatory Affairs Manager will provide direction, leadership, and regulatory oversight in the development and implementation of domestic and international regulatory strategies and processes to assure the timely global commercialization of products in compliance with applicable regulations and standards as a part of the regulatory asset management team. Working collaboratively in a cross-functional environment on a diverse range of topics that require in-depth Regulatory knowledge, understanding of industry trends, and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership. As a part of the regulatory asset services team, the Manager will additionally provide direction and support to centralized submissions planning, lifecycle management solutions, and regulatory intelligence activities, and supervise the preparation and planning of regulatory deliverables to introduce new/ changed products to domestic and international markets for assigned asset(s).  Responsible to assist in the preparation of departmental and project budgets as well as vendor management for services outsourced by the regulatory department relevant to assigned asset(s). 

Requirements of the Regulatory Affairs Manager

High School Diploma or GED

Minimum 5 years of experience in regulatory affairs

Experience in writing and submitting successful regulatory submissions both domestic and international.

Experience with electronic submissions, specifically eCTD and the use of Major Regulatory Authority Platforms/Gateways.

Excellent oral and written communication skills

Must be proficient in MS Office 365 (with an emphasis on MS Word, Teams, and Excel)

Experience with Adobe Acrobat and publishing-related plugins and viewers

Highly motivated, and results-oriented leadership style.

Ability to be flexible with changing priorities.

Ability to travel approximately 20%

Preferred:

Regulatory Affairs Certification (RAC) or comparable regulatory credential

Experience in regulatory affairs with matrixed management responsibilities

Previous experience with IND/CTAs and Drug/Biologics Pathways

Strong knowledge of eDocument Management Systems (eDMS) and eCTD Publishing Systems and Regulatory Information Systems (VEEVA platforms, RIM preferred)

Responsibilities of the Regulatory Affairs Manager

The specific duties of the Regulatory Affairs Manager include but are not limited to:

Acts as a global regulatory lead to drive asset or portfolio-level global development and submission activities across the lifecycle i.e. lead candidate selection through post-marketing to include development of target product profile, regulatory pathway, and product designations, planning, authoring, reviewing, coordination, and marketing authorization activities through post-market surveillance and change management activities.

Regulatory Affairs Point of Contact (POC) for the Regulatory Authority for assigned asset(s). Negotiate and interact with regulatory (domestic and international) authorities during the development, review, in stages peri-approval through marketing/pre-marketing applications (IND/CTA, NDA/BLA, PMA, 510K, RMAT/PRIME, PIP/PAS) procedures to ensure the necessary market authorization/clearance.

Prepare or maintain technical files as necessary to obtain and sustain product approval/clearance

Provide regulatory oversight for assigned assets and the regulatory maintenance of marketed products in-scope of the assigned asset. Ensuring reporting compliance through timely, appropriate, and accurate assessments (including assessments of change) regarding product surveillance, pharmacovigilance, product complaint handling, medical device reports (MDRs), adverse events, and field actions (recalls, corrections, removals). Responsible for AE, MAUDE, and periodic safety report filings as appropriate for the asset and filing of adverse event notifications to domestic and international Regulatory Authorities.

Management of regulatory activities associated with development programs for the assigned asset including tracking the status of regulatory submissions and project assignments, providing status updates, and other communications to Sr. Leadership and consumers of regulatory information.

Manage processes involved with maintaining annual licenses, registrations, listings, and patent information

Provide guidance to multidisciplinary teams on the content, format, style and architecture of Clinical Trial Authorizations (IND/IMPD/CTAs) for Domestic and ex-US/ex-EU studies. Provide regulatory submission requirements and submission plan for US, ex-US, and ex-EU.

Provides regulatory reviews in the context of Medical, Legal, Regulatory (MLR) expectations, and technical regulatory advice to prepare pre-marketing and post-marketing submissions and ensure high-quality standards that meet expectations.

Provide input on and regulatory de-risking reviews for specifications, process design controls, human factors study protocols, prescribing information (PI/PIL), instruction for use (IFU), artwork, and other labeling and marketing materials, etc. as the global Regulatory lead for the asset or program.

Manage processes involved with maintaining annual licenses, registrations, and FURLs including establishment and device listings as appropriate.

Perform regulatory intelligence for information, guidance, and standards pertinent to Axogen assets including our pipeline and provide a preliminary assessment of the impact of new or modified regulations and guidance. Identify and further develop contracts/services with vendors which support streamlining and advancing our Regulatory Intelligence capabilities.

Support Regulatory Authority Inspections or Audits when necessary

Communicate options and recommend solutions to a wide range of difficult problems. Foster collaboration with Sales, Marketing, and Clinical to develop effective global launch plans.

Provide continuing regulatory education and dissemination of regulatory information to the Research and Development teams, Operations team, Marketing, and Clinical teams.

Compensation

The anticipated base wage or salary range for this position is 105-135K plus up to 15% of base annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, Equity, and Disability insurance, as described in more detail in summary plan descriptions.

Company is on a hybrid work schedule at some facilities, with 3 days in office and 2 days remote.

Business Development Executive-perm-Northeast Territory and International-based in Boston area

My client is a trusted, full-service, contract development manufacturing organization (CDMO) producing organic chemicals for investigational and commercial pharmaceutical products since 1956. Their 80,000 sq/ft. of manufacturing and laboratory facilities are centrally located in the Chicagoland Area serving Biotech and Pharmaceutical companies around the world.

Regis Offerings

• CGMP Manufacturing for API and HPAPI
• Process Development and Scale-up
• Solid State Chemistry and Micronization
• Analytical Method Development and Validation
• Impurity Isolation, Characterization, and Reference Qualification
• Stability Storage and Product Testing

This role will report to the Director of Business Development and will support activities related to strategic business development in the Northeast Territory and International. The Business Development team provides key leadership to company.

Essential Duties & Responsibilities

• Develop new business for CGMP Manufacturing and associated Pharma Services to achieve Sales Order Target objectives in territory.
• Perform sales role by prospecting, communicating with clients, negotiating, and closing opportunities.
• Structure and negotiate contracts and proposals with an eye toward detail.
• Maintain relationships with existing client base to develop and close repeat business opportunities.
• Recognize client needs
• Design Custom Synthesis and Services Sales plans for territory and execute with reporting into CRM
• Interact and effectively communicate with all departments at company
• Match prospective opportunities that are “good fits” for our capabilities and resources
• Qualify opportunities, scope RFPs, review proposals
• Represent us to clients in a positive and professional manner

Qualifications

• A science degree (B.S. or higher) is required, with a focus in any of the following fields: Chemistry, Biology, Biochemistry, or other relevant life sciences field.
• A minimum of five (5) years of sales/business development experience in contract manufacturing or chemical synthesis is highly preferred.
• Comprehension of CGMP, phases of drug development, FDA requirements
• Analytical and strategic thinker possessing a sense of appropriateness and business acumen.
• Prolific networker with strong existing business development connections within biotech companies.
• Superior communicator with effective strategies for addressing various audiences.
• Project management skill, attention to detail and ability to follow-through on multiple projects.
• Collaborative, transparent and ability to foster teamwork.
• Deliver quality results under pressure in a dynamic environment within tight time constraints.
• Strong MS Excel and PowerPoint skills.
• Willingness to travel up to 50% to various networking events, conferences, and target/partner sites.
• Must reside within the territory with a strong preference for the Greater Boston Area.

Offering a very competitive base salary plus bonus, comprehensive benefits package, relocation if needed

If interested, please send your updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately

Unfortunately, Visa sponsorship or transfer NOT available for this role