Associate Director, Process/Facility Engineering

Job Description

Associate Director – Process/Facility Engineering (P4)

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director – Process/Facility Engineering position will report to the Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. CERD is responsible for enabling the pipeline including the demonstration of commercial chemistry and the delivery of clinical material.

The process/facility lead role at the Associate Director level will serve as a technical mentor and process team leader supporting the (two) Potent Prep Labs.  The Prep Lab is used to generate data which contributes to the knowledge capture of process scale-up and provides API and intermediates for further development and clinical trials. This kilo scale capability establishes operating parameters and ensures successful batches when transferring to pilot scale.  RY800-C169 is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing kilo scale laboratory and RY800-B164 is a multi-modality potent development lab, both located at our Rahway, New Jersey campus The Process/Facility Lead will act as a key leader within the Prep Lab team and will serve as a Subject Matter Expert (SME) in potent, cross-modality, GMP processing and overall capabilities of the labs. 

The incumbent will lead small teams of operations specialists, project team members, and potentially insourced staff in planning and executing shop floor operations for projects running batches in the Prep Lab. The Associate Director will manage operations specialists and be directly responsible for their onboarding and technical growth, as well as people management responsibilities such as employee development plans (EDP), compensation planning, and performance reviews. The Associate Director will collaborate with their peers in the Prep Lab Team, the Enabling Facilities group and other operations areas such as MACS and the SSO (see below), as well as key stakeholders in Small Molecule Process R&D, Biologics Process R&D, Analytical R&D, Quality, and Safety.

This is a hands-on leadership role which includes executing batches. The role will be accountable for driving strategic improvements between periods of GMP and non-GMP manufacturing as well as shop floor tactical execution during both GMP and non-GMP manufacturing with a focus on GMP execution. The role will flow between strategic and tactical assignments, based on the needs of the business.

The selected candidate is expected to foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers, chemists, & analysts, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, introduce new technologies, and ultimately to enable flexibility and speed of the Company’s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.  

Some specific responsibilities include the following:

• Primary liaison with lab-based project team members for any steps being run in C169/B164.  As such, is actively involved in planning and technical transfer of lab processes to the Prep Lab (often the first scale-up opportunity), integrating operational best practices and previous learnings to ensure successful performance in the prep lab. 

• Leadership and hands-on execution for GMP processing and non-GMP development work.

• Engineering Step lead for all steps run within C169. 

• Oversee campaign planning and equipment utilization

• Management of electronic batch record process.

• Reviews Process Description and provides coaching to the development team as needed.

• Leads or supports process improvement initiatives (Batch sheet Templates, PAT, knowledge capture, onboarding / training, equipment data sheets, etc.).

• Maintains “just in time” consumables inventory consisting of novel single use equipment for both potent and cross modality operations

• Provides support to the C169 Lab Lead in compliance initiatives, shop floor staff planning, and mechanical setups as needed. Interfaces with Compliance lead for Quality notification investigation related to processing.

• Ownership of Quality investigation closeouts

• Review of GMP documentation

Additional Supported Areas:

As required by the business and in addition to support of the Prep Lab facility the Associate Director will provide direct support of the other areas such as:

• Modality Agnostic Chemistry Scaleup (MACS): The MACS Center is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. Like the SSO, MACS is a GMP facility in the PR&D organization and shares its mission with the SSO but is focused on potent, cross-modality processing.

• Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization.  The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.

Education Minimum Requirement: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 7 years relevant experience, or a Master’s degree with 6 years of relevant experience, or a PhD degree with 4 years of relevant experience.

 

Required Experience and Skills:

• Experience with small molecule drug substance and/or biologics process development.

• Experience providing technical mentorship.

• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills and ability to multi-task.

• Desire and willingness to learn, contribute and lead.

• Track-record of independent problem-solving.

  

Desired Experience and Skills:

• Experience in GMP clinical supply facility

• Experience with Potent Compound processing and containment systems (e.g., isolators).

• Experience interacting with or overseeing the management of process utility systems

• Experience with coordinating maintenance activities around processing to support reliable facility operation.

• Experience in leading and supporting compliance investigations and change management.

• Experience with electronic batch record systems.

• Experience with clean room operations and equipment qualification.

• Familiarity with US and EU GMP and Safety compliance regulations

• Ability to convert new drug substance processing needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Experience with managing direct reports or matrix teams.

• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)

• Experience building high performance teams, from recruiting to onboarding to ongoing talent development. 

Required Skills:

Preferred Skills:

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US and Puerto Rico Residents Only:

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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:

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The salary range for this role is

$142,400.00 - $224,100.00

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 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.

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

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. 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/11/2026

*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.