What are the responsibilities and job description for the Director Large Molecule Development position at Merck Sharp & Dohme?

Job Description

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The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics including monoclonal antibodies (mAbs), di- & tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, 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 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 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 our Research & Development Division and our 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 (SDPC, our Manufacturing Division) 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 Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists. The successful candidate will effectively partner with Biologics and Biopharmaceutics 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’s 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 Biologics and Biopharmaceutics strategy.

Project management skills.

Attention to technical detail.

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.

Must be available to work on-site at the Rahway, NJ facility. This is not a remote position.

Qualifications : Education :

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

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

Required :

Relevant experience in pharmaceutical development with exposure to all stages and aspects of development (pre-clinical, clinical, and commercial) and cGMP industrial background.

Experience with design of IV and SC drug products including drug-device combination products for biologics.

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.

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

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

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

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.

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.

Demonstrated ability to identify, mitigate and clearly articulate program risks.

Preferred Experience and Skills :

Experience in developing broad suite of sterile products and understanding of parenteral formulation development.

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

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.

Experience in equipment Fabrication, FAT / SAT, start-up, qualification and / or validation is preferred.

Fill / finish process scale-up, Drug Delivery and / or technology transfer experience including the use of gap analysis and risk assessment tools.

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

Willing to implement novel and innovative technologies into large molecule programs. 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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