Associate Director, Biologics Process Operations

Company: Merck
Location: Rahway
Posted on: April 7, 2025

Job Description:

Job DescriptionApplications 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 a 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.Manage an organization of 8-10 exempt and non-exempt employees responsible for bulk clinical manufacturing of biologic drug substances, including limited hands-on assignments on the processing floor. Responsibilities include: Leading clinical manufacturing of our Company's biologics programs, coaching and maintaining an effective operations team, driving best practices, providing strategic direction of the organization, and partnering with Process Development, Quality, Facilities & Engineering to achieve successful clinical manufacture and release.Responsibilities Include:

• 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).
• Leadership Skills: Ability to provide functional leadership through delegating, developing, and motivating employees. Establish and maintain productive cross-functional partnerships with diverse groups internal to the organization and with key stakeholders.
• Training skills: Ability to train employees in technical, compliance, safety, and environmental procedures; ability to write SOPs, batch records, technical reports and present to peers and senior management.
• Analytical skills: Ability to analyze complex data and make recommendations for actions.
• Project Management skills: Ability to serve as subject matter expert and lead multidisciplinary project teams.
• Communication skills: Strong organization, negotiation, presentation, written, and verbal skills.
• Innovation Skills: Ability to conceive and implement innovative technologies that can reduce cost and production lead time. Able to implement and facilitate changes. Effectively apply state-of-the-art technologies and best practices to improve operational efficiency.
• Planning/Strategic Thinking: Ability to develop goals/objectives and translate them into action plans that benefit the department long term.Education Minimum Requirement:
  • BS with greater than 8-10 yrs experience. MS or Ph.D. degree in Biological Science, Engineering or Life Science with greater than 5 yrs experience.Required Experience and Skills:
    • 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.
    • The incumbent should be highly motivated with the ability to work in a fast-paced setting.Preferred Experience and Skills:
      • 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.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 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 ModelEffective 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. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.Expected US salary range: $139,600.00 - $219,700.00Available 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.Search Firm Representatives Please Read Carefully: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.Employee Status:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:04/18/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID:R343365
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Keywords: Merck, Trenton , Associate Director, Biologics Process Operations, Executive , Rahway, New Jersey