Director, Sterile Product Development

Job Description

The Mixed Modality team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including monoclonal antibodies (mAbs), di- & tri-specific antibodies, and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and development of formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products.  These sterile products include those administered via intravenous, subcutaneous, or intramuscular routes of administration. This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, processes and device/ packaging that enable patient centric products for patients.

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 vision to influence the regulatory environment

• Will be responsible for sub-functional strategic planning, coordinating, and execution of 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 timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.

The incumbent will drive large molecule sterile portfolio while developing new ways of working to meet aggressive timeline requirements and integrate within the broader parenteral portfolio, where appropriate. The incumbent will also have to demonstrate domain expertise in sterile product development and collaborate effectively with multiple stakeholders across both Reseach & Development Division and Manufacturing Division- in particular Discovery Pharmaceutical Sciences, Biologics Analytical Research and Development (BAR&D), Bioprocess research and development (BPR&D), and Sterile Product Development & Commercialization in the design of new formulations and development of robust and scalable processes for commercial products. The applicant will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across the external academic and regulatory community is expected, 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 Mixed Modalities, have a 10-15 group size composed of experienced, senior and associate scientists.  The successful candidate will effectively partner with Mixed Modality leadership and extended leadership teams to implement strategy, conduct scientific research 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 parenteral development processes for human health while ensuing a phase appropriate approach during early development.

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 commitment to a diverse and inclusive work environment.

Essential Knowledge, Duties & Responsibilities for the Director Include:

• Sterile drug product development concepts, tools, and 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 ADC, Complex Biologics and Small molecule portfolio.

• Project management skills

• Attention to technical detail

• Builds collaborations across internal our company