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 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.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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