Associate Director, Supply Chain Management Lead

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Companys biologics pipeline. We work closely with colleagues in Discovery Pre-clinical and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility which will be a premier state-of-the-art facility that is a key part of our Chemistry Manufacturing and Controls (CMC) hub at our site headquarters in Rahway NJ. This facility will be fully online in the next few years both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites which can adjust as the clinical pipeline demands change. It is capable of meeting all historic currently existing and cutting-edge biologics program demands from supporting development to pilot scale small and large scale potent material handling and the ability to integrate new technologies and cell-line platforms.

The Associate Director Supply Chain Management Lead will oversee the warehouse team and will be a member of the NGB Operations Leadership team reporting to the Head of Operations. They will be responsible for managing and coordinating the warehouse and facility supplies in alignment with the Process operations teams needs and ongoing GMP facility activities. Beyond warehouse workflows this individual will be a key leader in the pilot plant supply chain network and integrated into the Rahway site warehousing operations.

Job Responsibilities:

• Oversee all NGB warehouse operations ensuring compliance with GMP storage requirements and handling considerations.

• Manage the logistics team responsible for material movement inventory control outbound logistics local cell banks and ensure compliance with EHS and quality standards.

• Interact with various on-site and off-site centralized warehouse partners to ensure shipping and reciept of NGB materials is scheduled and delivered.

• Integrated into the Process Operations leadership team in order to better understand clinical campaign needs and voice of the customer.

• Oversee warehouse operations including storage and handling of cryogenic frozen and ambient materials and includes all SAP/COMET system transactions.

• Working as a lead for the materials planning and management function to build ERP (i.e. SAP) for the new facility.

• Drive continuous improvement in warehouse processes and collaborate with operations engineering safety and quality teams.

• Deliver on quality adherence and performance metrics.

• Conduct audits and inspections approve SOPs and monitor adherence to GMP standards.

• Develop strategies to optimize warehouse operations and improve efficiency.

• Establish priorities for raw material (RM) and single-use process consumables procurement in collaboration with operations teams.

• Track and manage inventory of RMs and GMP Supplies (including but not limited to single-use technology and product contact components).

• Manage and provide guidance to junior staff on all aspects of materials management.

Required Education Experience and Skills:

Education:

• Minimum of bachelors degree in chemical/biochemical engineering pharmaceutical sciences chemistry biochemistry biology microbiology or related discipline with minimum of 8 years pharmaceutical materials management experience.

Experience & Skills:

• Demonstrated experience in a GMP-regulated manufacturing environment ideally pertaining to biologics drug substance materials using single-use systems.

• Prior experience of implementing or working within SAP for GMP operations or proficiency of SAP usage in biopharma environment.

• Strong working knowledge of cGMP Quality Systems (problem deviations change management etc.) and safe operating practices for operations.

• Prior experience in people management team performance management for shop floor activities coordination of cross-functional warehouse teams and regulatory compliance.

• Strong focus on delivery metrics and quality adherence.

• Demonstrated proficiency in logistics inventory management and quality systems.

Preferred Experience and Skills:

• Culture Building: Establish a high-performance culture that promotes innovation diversity and inclusion within the team.

• Track record of working effectively with team-members of diverse skill sets and backgrounds.

• Strong verbal and written communication skills.

• Experienced in the administration of GMPs Good Documentation Practices (GDPs) and S&E regulations as it pertains to materials handling.

• Experience with operationalization of GMP Materials Management and warehouse operations as well as ability to work in a fast-paced environment.

• Proven self-motivation ability to drive improvements and inspire others.

• Strong problem-solving skills and excellent attention to detail highly independent with initiative.

• Ability to challenge the status quo with a continuous improvement mindset.

• Ability to lift 25 lbs if required.

#PRD PRD

Required Skills:

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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.

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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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