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

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi‑modality drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non‑Sterile (Oral Solid Dosage) Process Engineering team ensures right‑first‑time manufacture and delivery of high‑quality drug products (spray‑dried intermediates, tablets and capsules) by applying pharmaceutical unit operations such as spray‑drying, hot‑melt extrusion, blending, roller compaction, encapsulation, compression, and film coating.

The FLEx Center supports partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to accelerate delivery of new medicines to clinical trials.

Lead clinical supply manufacturing with scientific rigor of processes, enabling flexibility and speed for the company’s pipeline.

• Strategically plan on‑floor batch manufacturing to ensure safety and quality of clinical supplies.
• Mentor a team of 2–5 process engineers through technical coaching and performance development.
• Review and approve GMP documentation including batch records, specifications, equipment qualifications, change records and deviations.
• Provide technical oversight to immediate and indirect teams to support continuous improvement and operational excellence.
• Own impactful technical projects that apply Design of Experiments and Quality by Design principles to enhance process understanding, address gaps, or accelerate scale‑up to commercial manufacturing.
• Perform early assessments of proposed new technologies to evaluate feasibility.
• Communicate technical results and initiatives through presentations and publications.
• Engage partner organizations to support successful scale‑up to commercialization.
• Collaborate across work groups of formulators, engineers, technicians, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation.

• Experience in operations supporting or leading GMP manufacturing facilities.
• Experience authoring, reviewing and approving batch records and other GMP documentation, quality investigations and change controls.
• Extensive knowledge of small‑molecule GMP drug product processing, process robustness assessments, root cause analysis, change control and deviation management.
• Track record of operating in a fast‑paced environment to resolve manufacturing issues.
• Independent problem‑solving to identify, characterize and address manufacturing challenges through rationalization and first‑principles understanding.
• Strong knowledge of cGMP, FDA, EMA and other international regulatory requirements.
• Experience supporting oral solid dosage forms (tablets, capsules).
• Strong communication skills, verbal and written.
• Leadership qualities including collaboration, change management, accountability and adaptability.

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

• Subject‑matter expert in at least one drug delivery and/or manufacturing technology.
• Broad experience in related areas including formulation, analytical sciences and commercialization.
• Knowledge of drug regulatory requirements.
• Audit experience in 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, creating learning environments and monitoring growth.

Operational coverage across multiple shifts. Candidates must be willing to float between 1st and 2nd shift and accommodate variable working hours as campaign requirements dictate.

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 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 the EEOC website. We are proud to embrace the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds.