Job Description

Our Global BioTechnology Support - Process Development (BTS-PD) group, is accountable for technology transfer of new biopharmaceutical products from R&D to commercial production. This team leads critical technical activities such as scale-up, process validation/qualification, and process optimization & robustness to ensure successful product launches and maintain robust product supply. In addition, processes need to be transferred to manufacturing site, either internal or with external manufacturing (CDMO) partners. This entails strategic planning and risk management, change control, Process Performance Qualification towards regulatory filing and approval.

Your role

The Associate Director, Biologics New Product Commercialization for monoclonal antibodies (mAbs) is accountable for collaborating with technical SMEs in R&D and at manufacturing sites (internal and external) to transfer new veterinary mAb products from R&D into commercial manufacturing sites. This position provides matrix leadership of a cross-functional project team that drives technology transfer and supports product registration. This critical role provides project management from the first point of contact with R&D through process transfer, Process Performance Qualification, regulatory filing and approval and post-launch support. Reporting progress, escalating issues and highlighting Technical or project management risks to leadership are also an essential aspect of this position.

This role can be located in Boxmeer (NL), Millsboro, DE (USA) or DeSoto, KS (USA).

Job Responsibilities:

This is an individual contributor role with matrix leadership of cross-functional teams to deliver technology transfers for new veterinary monoclonal antibody (mAb) products from R&D into commercial manufacturing (internal & external). To achieve this goal, the position will:

• Partner closely within other Biotechnical Support groups, R&D, and manufacturing sites (internal & external CDMOs) to enable on-time, right-first-time product launches.
• Drive effective project execution through robust planning of budgets, timelines, resources and key milestones for new product transfers.
• Maintain oversight of project schedules, risks and issue registers, and escalate proactively to support successful delivery.
• Provide technical project management throughout the transfer lifecycle, including: internal & CDMO process development, technical reviews, process risk assessments, technology transfers and launches at Internal and External Manufacturing sites.
• Communicate project progress, risks and key decisions clearly to senior stakeholders, governance bodies and global project teams.
• Help shape and strengthen best practices, standards and ways of working within your area of expertise.

Required Qualifications

• Bachelors of Science in Chemical Engineering, Biotechnology, Biochemistry, or related field with at least eight (8) years of relevant post-graduate experience
  • Or Master of Science degree and at least six (6) years of relevant post-graduate experience
  • Or a Doctoral degree with at least four (4) years of relevant post-graduate experience

• Minimum four (4) years of relevant experience as a project leader who can maintain oversight, manage priorities, and deliver on-time results in a complex, fast-paced matrix organization; regulated biopharmaceutical environment
• At least two (2) years of relevant experience with external manufacturing sites (CDMOs)
• Strong expertise in technology transfer methodology and technical problem-solving, with the ability to turn complexity into practical solutions
• Demonstrated effective collaboration with key stakeholders, including: R&D, Manufacturing sites (internal & external), Analytical, Quality, Supply Chain and Regulatory Affairs.

Preferred Qualifications

• Deep technical knowledge in mAb products and manufacturing processes
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines
• Strong working knowledge of key biopharmaceutical business processes, including: Process Performance Qualification/Validation, risk assessments, CMC regulatory processes, and manufacturing change control

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

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Travel Requirements:

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