Associate Director, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company’s research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials.

The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineering to lead clinical supply manufacturing with scientific rigor of processes, to ultimately enable flexibility and speed of our company's pipeline.

This person will:

• Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.

• Mentor a team of 2-5 process engineers by technical coaching and developing for success through feedback and development guidance.

• Review and approve GMP documentation including but not limited to batch records, specification, equipment qualifications, change records and deviations.

• Provide technical oversight to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence

• Own impactful and complex technical projects that leverage Design of Experiments and Quality by Design (QbD) principles to increase process understanding, address gaps or accelerate scale-up to commercial manufacturing

• Perform early assessments of proposed new technologies to identify feasibility

• Communicate technical results and technology initiatives through internal and external presentations and publications

• Engage with partner organizations for successful scale-up to commercialization.

• Build within and across work groups of formulators, engineers, technicians, safety and quality representatives.

• Foster culture of collaboration, learning and innovation.

• Support in setting specific and measurable short- and long-term goals.

Required Experience and Skills:

• Experience in operations, supporting or leading GMP manufacturing facilities.

• Experience authoring, reviewing and approving batch records and other types of GMP documentation, quality investigations and change controls.

• Extensive knowledge, experience and proven expertise in small-molecule GMP drug product processing, particularly in process robustness assessments, root cause analysis, change control, and deviation management.

• Proven track record in operating in a fast-paced environment to resolve manufacturing issues

• Demonstrated ability of independent problem-solving to identify, fundamentally characterize and address manufacturing challenges through in-depth rationalization and understanding of first-principles.

• Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.

• Small molecule portfolio leadership, with experience supporting oral solid dosage forms (tablets, capsules)

• Desire and willingness to learn, contribute and lead through.

• Desire and willingness to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies

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

• Possess leadership qualities such as working collaboratively, managing change, accountability, adaptability and other attributes in a diverse, cross-functional team.

Education Minimum Requirements:

Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum of 10 years relevant experience, or a Master’s degree with 8 years of relevant experience, or a PhD degree with 4 years of relevant experience.

Preferred Experience and Skills:

• Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology

• Breadth of experience in related functional areas, including: Formulation, Analytical Sciences, and Commercialization

• Knowledge of drug regulatory requirements

• Audit experience: manufacturing, safety, environmental, compliance/quality

• Understanding of Clinical Supply Chain Operations

• Experience with spray dried intermediates and/or hot melt extrusion

• Experience with technical transfer of early-phase drug product

• Experience managing and developing teams, including identifying and assessing goals, creating a learning environment and monitoring progress of growth.

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able tofloat between 1st and 2nd shift.

Work schedules for this role will vary based on the needs and timing of assigned campaigns. While standard working hours will apply most of the time, there may be occasions when you are required to work earlier, later, or extended hours to support campaign requirements. Reasonable notice of schedule changes will be provided whenever possible.

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Required Skills:

Accountability, Accountability, Adaptability, Biomedical Engineering, Biomedical Sciences, Change Management, Chemical Engineering, Clinical Trials Operations, Customer-Focused, Data-Driven Decision Making, Drug Delivery, Drug Product Development, Emergency Care, Engineering Standards, Estimation and Planning, GMP Compliance, Manufacturing Audits, Manufacturing Quality Control, Orthopedics, Pharmaceutical Process Development, Pharmaceutical Sciences, Process Control Automation, Process Engineering, Process Optimization, Product Formulation {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here if you need an accommodation during the application or hiring process.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/5/2026

*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.