Director, Raw Materials & Medical Device Analytical R&D

Job Description

Raw Materials & Medical Device Director, Small Molecule Analytical Research & Development

The Small Molecule Analytical Research and Development (SMAR&D) GxP Operations team has an opening for a Director based in Rahway, NJ. The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies. In this role, the Director of the Raw Materials and Medical Devices will lead a team of approximately 10 specialists and scientists supporting excipients, package component, medical device component, and combination product release testing across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a state of inspection readiness at all times. The Director should be well engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.

In addition, the Director will effectively partner with SMAR&D leadership and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard, and develop employees to their full potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.

Primary Responsibilities:

• Leading a team of specialists and scientist supporting raw material release and medical device & combination product testing

• Ensuring on-time release testing of raw materials to enable clinical manufacture, right first time

• Contract laboratory oversight including supporting any lab investigations and deviations

• Review and approval of GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs.

• Serve as the raw material & MDCP SME during internal and external compliance audits

• Ensuring operational excellence and drive process improvements

• Staff development and talent recruiting

• Work with the leadership team to help drive departmental strategic and cultural initiatives

Education Minimum Requirements:

BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development. Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.

Required Experience and Skills:

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills

• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines

• Proven talent development skillsets

• Ability to partner in a team environment with cross-functional interactions to drive results

Preferred Experience and Skills:

Though not required, the ideal applicant would have prior experience managing a GMP lab that supports raw material, excipient, and/or package component release testing. Prior experience with medical device components and combination products is a plus.

#AR&D

Required Skills:

Accountability, Accountability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Chemical Biology, Chromatographic Techniques, Communication, Cross-Functional Teamwork, Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness, Medical Device Management, Medical Device Manufacturing, Medical Devices, People Leadership, Personnel Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance, Regulatory Submissions, Release Testing, Results-Oriented {+ 5 more}

Preferred Skills:

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