Merck
Associate Director, Process Operations Lead
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Associate Director, Process Operations Lead
role at
Merck .
The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state‑of‑the‑art facility and a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, current, and cutting‑edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell‑line platforms.
The Associate Director, Process Operations Lead will be a member of the NGB Operations Leadership team, reporting to the Head of Production Operations.
Job Responsibilities
Strategic member of the capital project delivery project team providing Operational knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility.
Lead a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical campaigns.
Oversee the coordination efforts for Drug Substance Manufacturing Execution (Shop Floor Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
Manage the Operations team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.
Drive operational excellence for Right First Time (RFT) batch execution.
Oversee production planning and associated activities, integrated with the NGB Multiproduct platform.
Ensure operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
Accountable for the management of GMP systems in support of operations. Develop future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
Collaborate across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.
Required Education, Experience and Skills
Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master’s degree with minimum 6 years of relevant experience, or a PhD degree with minimum 3 years of relevant experience.
Experience & Skills
Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single‑use systems.
Prior experience of operations team management and monitoring performance.
Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.
Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.
Experience with facility fit assessments, New Product Introduction, transfer of processes to and from clinical site, and clinical manufacturing experience.
Delta V and MES (Manufacturing Execution System) knowledge and experience
Ability to perform technical analysis using software such as JMP, efficiency in Microsoft office, project management (plus), communication.
Preferred Experience And Skills
Experience in Lean Manufacturing & Root Cause Analysis
Previous experience in process engineering, upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.
Experience with operationalization of GMP operations and/or large facility builds or renovations as well as ability to work in a fast-paced environment.
Proven self‑motivation, ability to drive improvements, and inspire others.
Demonstrated ability to work effectively as part of diverse teams.
Strong problem‑solving skills and the ability to overcome technical and organizational challenges.
Excellent attention to detail, highly independent with initiative.
Excellent troubleshooting and problem‑solving skills.
Ability to challenge the status quo with a continuous improvement mindset.
Strong leadership ability and collaborative skills.
Strong analytical and presentation skills.
Ability to lift 25 lbs, if required.
Salary Range $139,600.00 - $219,700.00. The salary is the low‑to‑high salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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.
Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, healthcare, 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.
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. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. Learn more about your rights, including under California, Colorado and other US State Acts.
How to Apply 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.
Requisition ID: R378644
Job Posting End Date: 01/31/2026
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Pharmaceutical Manufacturing
Location restrictions: US And Puerto Rico Residents Only.
Applicants from San Francisco or Los Angeles are welcome under the respective state fair chance ordinances. Search firms are not accepted for this position.
Domestic relocation is required; no visa sponsorship; no travel required; flexible work arrangements not applicable; shift not indicated; valid driving license not required; hazardous materials unknown; job posting end date as above.
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Associate Director, Process Operations Lead
role at
Merck .
The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state‑of‑the‑art facility and a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, current, and cutting‑edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell‑line platforms.
The Associate Director, Process Operations Lead will be a member of the NGB Operations Leadership team, reporting to the Head of Production Operations.
Job Responsibilities
Strategic member of the capital project delivery project team providing Operational knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility.
Lead a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical campaigns.
Oversee the coordination efforts for Drug Substance Manufacturing Execution (Shop Floor Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
Manage the Operations team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.
Drive operational excellence for Right First Time (RFT) batch execution.
Oversee production planning and associated activities, integrated with the NGB Multiproduct platform.
Ensure operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
Accountable for the management of GMP systems in support of operations. Develop future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
Collaborate across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.
Required Education, Experience and Skills
Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master’s degree with minimum 6 years of relevant experience, or a PhD degree with minimum 3 years of relevant experience.
Experience & Skills
Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single‑use systems.
Prior experience of operations team management and monitoring performance.
Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.
Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.
Experience with facility fit assessments, New Product Introduction, transfer of processes to and from clinical site, and clinical manufacturing experience.
Delta V and MES (Manufacturing Execution System) knowledge and experience
Ability to perform technical analysis using software such as JMP, efficiency in Microsoft office, project management (plus), communication.
Preferred Experience And Skills
Experience in Lean Manufacturing & Root Cause Analysis
Previous experience in process engineering, upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.
Experience with operationalization of GMP operations and/or large facility builds or renovations as well as ability to work in a fast-paced environment.
Proven self‑motivation, ability to drive improvements, and inspire others.
Demonstrated ability to work effectively as part of diverse teams.
Strong problem‑solving skills and the ability to overcome technical and organizational challenges.
Excellent attention to detail, highly independent with initiative.
Excellent troubleshooting and problem‑solving skills.
Ability to challenge the status quo with a continuous improvement mindset.
Strong leadership ability and collaborative skills.
Strong analytical and presentation skills.
Ability to lift 25 lbs, if required.
Salary Range $139,600.00 - $219,700.00. The salary is the low‑to‑high salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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.
Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, healthcare, 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.
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. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. Learn more about your rights, including under California, Colorado and other US State Acts.
How to Apply 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.
Requisition ID: R378644
Job Posting End Date: 01/31/2026
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Pharmaceutical Manufacturing
Location restrictions: US And Puerto Rico Residents Only.
Applicants from San Francisco or Los Angeles are welcome under the respective state fair chance ordinances. Search firms are not accepted for this position.
Domestic relocation is required; no visa sponsorship; no travel required; flexible work arrangements not applicable; shift not indicated; valid driving license not required; hazardous materials unknown; job posting end date as above.
#J-18808-Ljbffr