Director: Vaccine Drug Product Development (Live Virus Vaccines)

Job Description

Our Company 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 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 bui