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

MSD•Rahway, NJ

1d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.