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

• Kn