General Description:

　　This position reports directly to the General Manager (Site Head) and is a site leadership position at Hopewell, NJ. Expectations of this role is to work collaboratively with other functional teams in providing material management service including W&D. Responsibilities include CQV commissioning and GMP readiness for Green-Field start-up conditions related to Cold chain systems of 2-8C and -40 C to -70C cryogenics freezers.

　　This role will focus on supporting from a materials management perspective, inventory management, Weigh and dispense of large scale powder and liquid, leading technical implementation of cutting edge large molecule manufacturing; Build an organization with strong core values and behaviors into a culture that supports high quality manufacturing processes.

　　Core Responsibilities/Experience:

　　Leading and building a highly skilled, focused and well trained organization.

　　Building an organization of professional core behaviors.

　　Must have specific technical experience in Global Health inspections for Warehouse Material Management.

　　Experience in leading of authoring, review, and update of SOP’s, MBRs, WI’s, Forms & Training documents

　　Must have good communication and writing skills including change controls, CAPA, and deviations.

　　Must have extensive experience in Weigh and Dispense for Bio-Pharmaceuticals, CHO cell production.

　　Provide daily on-hand support to all functional teams, as needed.

　　Harnessing safe behaviors and ensuring upmost importance for a safe working environment.

　　Lead and Participate in any CQV related activities including documentation preparation and execution, equipment installation and commissioning.

　　Line Clearance and product changeover

　　Strong experience in SAP for inventory management

　　Automatic Search and Retrieval Systems.

　　WMS experience.

　　50% of time should be on Production Shopfloor and 50% administration work during Phase 1.

　　To be responsible for leading commercial production according to schedule for the Phase 1 project timeline.

　　Responsible for Equipment FAT/SAT/IOQ/ and commissioning maintaining established timelines. Supporting EMPQ of Cleanrooms, Cold Chain described above.

　　Leading production teams in warehouse workshops, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production and release of Raw Materials.

　　To be responsible for effective management of product quality and cost control to ensure compliance with expected objectives and requirements.

　　Qualifications:

　　Bachelor's degree with a minimum 8 years of experience in ERP systems, warehouse materials management, weighing & dispensing, and material flow in the Biopharmaceutical industry and Biologics.

　　Familiarity with pharmaceutical manufacturing operations is preferred

　　Physical Requirements:

　　Must be able to stand for long periods, up to 8 to 10 hours/day

　　Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently

　　Must be able to work scheduled minimum 40 hours/week

　　Ability to lift up to 50 lbs

　　The working environment will require dedicated gowns to be worn and additional PPE as required

　　Comfortable and Knowledgeable

　　Computer Skills: Microsoft Software (Excel, PP, Word, Access etc.), ERP, WMS

　　Travel: 10%

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.