Description
Job Description
The Modality Agnostic Chemistry Scaleup (MACS) Operations 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 MACS Operations Lead Senior Director as a member of the MACS Operations Team at the Rahway NJ facility.
The Associate Director will serve as a technical mentor and process team member supporting the MACS Center, which is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The incumbent will build and lead a team of 5-10 engineers and operations specialists, and potentially insourced staff as well. The Associate Director will be responsible for their team’s onboarding and technical growth, as well as people management responsibilities such as employee development plans (EDP), compensation planning, and performance reviews. Since the facility is embarking on operational readiness and qualification the Associate Director will work alongside their peers in the MACS Operations Team, the Enabling Facilities group and other operations areas such as the SSO and Prep Lab (see below), as well as key stakeholders in Process R&D, Analytical, Quality, and Safety. They will be instrumental establishing the requirements in this first-of-a-kind facility by the ready for science target date of 2Q 2027.
As the MACS facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup and subsequent batch processing. The selected candidate is expected to build and develop a team of process/facility engineers and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, 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.
Additional Supported Areas
Required
As required and in addition to support of the MACS facility the Associate Director may need to provide direct support of the other areas at the Rahway site such as:
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.
Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.
Education Minimum Requirement
Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 8 years relevant experience, or a Master’s degree with 7 years of relevant experience, or a PhD degree with 5 years of relevant experience.
Required Experience And Skills
- Experience in GMP clinical supply facility.
- Experience with Equipment start-up and/or qualification.
- Experience providing technical mentorship.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in leading and supporting compliance investigations and change management.
- Familiarity with US and EU GMP and Safety compliance regulations
- Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
- Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
- Experience with quality systems
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
- Experience building high performance teams, from recruiting to onboarding to ongoing talent development.
Desired Experience And Skills
- Experience with GMP facility design, start-up, commissioning.
- Experience with managing direct reports or matrix teams.
- Experience with Potent Compound processing and containment systems (e.g., isolators).
- Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
- Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
- Experience with coordinating maintenance activities around processing activities to support reliable facility operation.
Required Skills
Accountability, Accountability, Adaptability, Applied Engineering, Bioconjugation, Chemical Engineering, Chillers, Communication, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance, Good Manufacturing Practices (GMP), Hazard Analysis, Leadership, Manufacturing Quality Control, Pharmaceutical Process Development, Pilot Plant Operations, Process Control Automation, Process Optimization, Product Formulation, Production Process Development, Quality Assurance (QA), Safety Compliance {+ 4 more}
Preferred Skills
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Current Contingent Workers apply HERE
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Requirements
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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. 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”.
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/International
VISA Sponsorship
Yes
Travel Requirements
10%
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
N/A
Job Posting End Date
04/23/2026
- 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.
Requisition ID:R390983
