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Director Large Molecule Development

MERCK
Rahway, NJ Full Time
POSTED ON 3/23/2025
AVAILABLE BEFORE 4/19/2025

Merck Director Large Molecule Development Rahway, New Jersey Apply Now

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.

Apply fast, check the full description by scrolling below to find out the full requirements for this role.

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 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.

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.

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.

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.
  • Attention to technical detail.
  • Builds collaborations across internal 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.
  • US and Puerto Rico Residents Only :

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

    We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

    U.S. Hybrid Work Model

    Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

    The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Expected US salary range : $169,700.00 - $267,200.00.

    Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.

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    Salary : $169,700 - $267,200

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