Director: Vaccine Drug Product Development (Manufacturing & Delivery Technologie

Job Description

Our Compnay is on a quest for cures and is committed to be the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. our Compa Research Laboratories is a true scientific research facility of tomorrow and will take our Company’s leading discovery capabilities and world-class R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Our Company is seeking a highly motivated candidate for the position of Director, Vaccine Drug Product Development. Vaccine Drug Product Development (VDPD) team is responsible for the research and development of vaccine drug products and various innovative technology platforms. The candidate will lead and direct the development for a range of vaccine modalities within our Company’s portfolio including live viruses, subunits, conjugates, VLPs, nucleic acid based vaccines, and be engaged in adjuvant development.

The successful candidate:

• Should have a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory environment, and competence to influence the functional partners and regulatory environment

• Will effectively team with VDPD leadership and extended leadership teams to implement strategy, direct phase appropriate research & development from the laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for vaccine development processes for human health

• Will be responsible for sub-functional strategic planning, coordinating, and execution of VDPD initiatives for the our Company portfolio from discovery to launch.

• Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across the organizations such as Quality, Regulatory CMC, and technical functions, to ensure development of robust & scalable processes, timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.

• Will drive disruptive innovation technologies while developing new ways of working to meet aggressive timeline requirements and integrate within the portfolio, where appropriate.

• Will be responsible for review of potential DP CMO opportunities, engage in technology transfer to commercial sites, and support manufacturing efforts including CAPAs, process monitoring, robustness, and characterization

• Will complete necessary phase appropriate risk assessments, and support regulatory filings including INDs/IMPDs and NDAs

• Is expected to have a strong network internally and across the external academic and regulatory community, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development

The Director will report to the Executive Director of Vaccine Drug Product Development, have 3 – 5 direct reports and will be responsible for a team of 10-20 senior and associate level scientists. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our Company’s commitment to a diverse and inclusive work environment.

Essential Knowledge, Duties & Responsibilities for the Director Include:

• Sterile drug product development concepts, tools, and technical/ operational/ regulatory requirements for all dosage forms (liquid, lyo, drug-device combinations)

• Review and approval of data and technical documents

• Ability to recruit, select, develop, and mentor talent.

• Strategic and critical thinking to advance VDPD strategy

• Project management skills

• Builds collaborations across internal our Company departments and key stakeholders.

• Ability to lead and champion organizational structure and be a change agent when necessary.

• Developing the departmental budget and meeting the agreed upon spend.

• Collaborates and builds strong relationships with upper management and other disciplines to select and qualify new CMOs/CROs/CDMOs

Qualifications:

Education:

• Ph.D. in pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, chemical engineering, biology, virology, or relevant field with minimum of 8 years of industrial experience.

• B.S. or M.S. in biochemistry, biology, chemistry, pharmaceutical sciences, biochemical / biomedical engineering, chemical engineering, or relevant field with minimum of 10 years of industrial experience

Minimum Qualifications Include:

• Experience in developing liquid, lyophilized, injectable drug product formulations and/or Drug Delivery and Technology initiatives. Knowledge of adjuvant evaluations, adjuvant development and understanding of parenteral formulation development.

• Experience with design of injectable sterile drug products including drug-device combination products for biologics or vaccine modalities (e.g. live virus vaccines, adjuvants, subunit, conjugated, RNA based)

• Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams & engineering drawings

• Process development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools.

• Experience with regulatory submissions including writing / review of regulatory filings including INDs and BLAs.

• Must be innovative and drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory posture

• Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong experience in safety and environmental knowledge and site presence.

• Candidate should have solid understanding of integration and partnering for Pharmaceutical development/CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas

• Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaboration skills.

• A strong track record of publications in parenteral drug product development and/or delivery

• Demonstrated ability to lead cross-functional teams with proven talent development skillsets.

• Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings for biopharmaceuticals or vaccine products.

Preferred Experience and Skills:

• Expertise in biological and/or vaccine clinical and commercial manufacturing would be ideal

• Strong process development (including upstream and downstream) and technology transfer experience is sought.

• Knowledgeable of the Capital Process having participated on a large capital project team

• Exposure to project / engineering work process and deliverables (e.g. equipment fabrication, FAT, SAT, Validation etc.)

• Experience in regulatory compliance expectations across all phases of product development to commercialization.

• Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).

• Experience in budget planning & management, establishing development strategies, and managing scientific staff from a budgetary and personnel decisions standpoint.

• Highly motivated, flexible, a change agent, and ability to work in a fast-paced environment.

• Willing to implement novel and innovative technologies into vaccine programs. Ability to provide novel and creative solutions to challenges and pinch points in vaccine development. Encourages innovative thinking / risk-taking and eliminates obstacles / barriers to implement change

• Ability to present clear and compelling quality and business cases. Ability to engage and align other stakeholders outside the project team.

• Ability to apply and promote a growth mindset with teams and partnerships

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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