General Description:

This position reports directly to the Director/Head of Supply Chain and is a 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.

This role will focus on supporting all cGMP operations from a materials management perspective, warehouse operations, inventory management, and 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.

• 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

• WMS experience.

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

• 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.

Professional Experience

• Bachelor's degree OR a minimum 7 years of experience in a cGMP/FDA regulated environment, including, but not limited to: materials management, inventory control, weighing & dispensing, and material flow.

• Minimum of 7 years of experience in Warehouse Material Management in the Biopharmaceutical industry and Biologics; mAbs.

• 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

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

Other Qualifications:

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.