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

Position Overview

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi‑modality drug product development and clinical manufacturing facility located in Rahway, New Jersey. The Non‑Sterile Process Engineering team ensures right‑first‑time manufacture and delivery of high‑quality drug products such as spray‑dried intermediates, tablets and capsules, leveraging unit operations including spray‑drying, hot‑melt extrusion, blending, roller compaction, encapsulation, compression and film coating. This team, part of the company’s research division, supports 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 is looking for an Associate Director – Process Engineering to lead clinical supply manufacturing with scientific rigor of processes, thereby enabling flexibility and speed of the company’s pipeline.

• Lead and strategically plan on‑the‑floor batch manufacturing to ensure safety and quality of clinical supplies.
• Mentor a team of 2–5 process engineers through technical coaching and development.
• Review and approve GMP documentation, including batch records, specifications, equipment qualifications, change records and deviations.
• Provide technical oversight to immediate and indirect teams, supporting continuous improvement and building operational and technical excellence.
• Own 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 evaluate feasibility.
• Communicate technical results and initiatives through internal and external presentations and publications.
• Engage with partner organizations for successful scale‑up to commercialization.
• Build work relationships across formulators, engineers, technicians, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation.
• Support setting specific and measurable short‑ and long‑term goals.

• Experience in operations, supporting or leading GMP manufacturing facilities.
• Experience authoring, reviewing and approving batch records and other GMP documentation, as well as quality investigations and change controls.
• Extensive knowledge and proven expertise in small‑molecule GMP drug product processing, particularly in 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 ability to identify, characterize and address manufacturing challenges through first‑principles reasoning.
• Strong knowledge of cGMP, FDA, EMA and other international regulatory requirements.
• Experience supporting oral solid dosage forms (tablets, capsules).
• Desire and willingness to learn, contribute and lead and to build new capabilities through the evaluation of new technologies.
• Effective interpersonal and communication skills, both verbal and written.
• Leadership qualities such as collaboration, change management, accountability and adaptability in a diverse, cross‑functional team.

• Subject‑matter expertise in at least one drug delivery and/or manufacturing technology.
• Broad experience in related functional areas such as formulation, analytical sciences and commercialization.
• Knowledge of drug regulatory requirements and audit experience in manufacturing, safety, environmental and compliance/quality.
• Understanding of clinical supply chain operations.
• Experience with spray‑dried intermediates or hot‑melt extrusion.
• Experience with technical transfer of early‑phase drug products.
• Experience managing and developing teams, including goal setting, creating a learning environment and monitoring progress.

Minimum:
Bachelor of Science in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 10 years relevant experience; or Master’s degree with 8 years of…