Associate Director, Biologics Process Operations

Merck & Co. • Rahway, NJ

279d • $139,600 - $219,700 • Onsite

About The Position

Applications are sought for a Process Operations Lead position in our Research & Development Division Biologics Process Research & Development (BPR D). The incumbent will support GMP capability built for manufacture of bulk biologic drug substance, as well as lead pilot-scale campaigns for the non-GMP manufacture of bulk biologic drug substance for pre-clinical supplies and development, as required. The GMP clinical manufacturing plant in Rahway, New Jersey will be a new facility, and this opportunity is for an individual to join our Research & Development Division Project team as a lead for GMP Process Operations in preparation for operational readiness, as well as provide leadership to the non-GMP operations. This is an exciting opportunity to enter the team at the ground floor and, manage broad scope of activities, understand the facility network, work in a brand-new facility, learn to work in a dynamic team environment, build your network, etc.

Requirements

• A minimum of 7 years relevant experience in biopharmaceuticals.
• Demonstrated ability to lead functional groups with proven people management and talent development skills.
• Strong knowledge of purification (chromatography, TFF, filtration) unit operations in a single-use environment, aseptic techniques, BSL1/2, clean room practices, closed system, bioprocessing equipment.
• Familiarity with ADCs manufacturing and cell culture processes a plus.
• Strong knowledge of cGMP, Quality Systems, Safety for operations.
• Experience with facility fit assessments, transfer of processes to and from clinical site, and clinical manufacturing experience.

Nice To Haves

• Previous experience in upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.
• Experience with operationalization of GMP operations.
• Working experience with manufacturing of antibody drug conjugates (ADC).
• A thorough understanding of regulatory/compliance expectations across all phases of product development and commercialization.

Responsibilities

• Serve as a scientific and technical resource for upstream and/or downstream operations, lead projects and provide guidance and training to operationalize the GMP operations and operations staff.
• Collaborate with multiple cross functional project teams, manage multiple projects, and establish and meet critical project timelines.
• Support the development of biopharmaceutical products (monoclonal antibodies, fusion proteins, bi-specifics, antibody drug conjugates (ADC)s, etc.) and ensure compliance at all stages of project.
• Design, plan, and efficiently execute batches, effectively evaluate data, and troubleshoot and solve problems, as needed.
• Recruit, manage and engage personnel, plan and assign work, and manage performance. Provide guidance, coaching and mentorship, motivating staff to achieve department/personal objectives.
• Establish both an internal and external network. Active participation in appropriate professional organizations (e.g. PDA).

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree