Sr. Specialist - Warehouse Operations (Onsite)
Our Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline. We collaborate with Discovery, Pre-clinical, and Early Development teams to rapidly develop processes for biotherapeutics and produce material for clinical trials. Additionally, we handle commercial process development and implement new technologies, working closely with the Manufacturing Division to commercialize and launch new products.
This role supports the Next Generation Biologics (NGB) facility, a state-of-the-art, multi-product GMP facility in Rahway, NJ, designed for flexible operations to meet evolving clinical pipeline demands. The facility supports development, pilot-scale production, potent material handling, and integration of new technologies and cell-line platforms.
Responsibilities
- Lead daily warehouse activities, including receiving, storage, picking, staging, kitting, and shipping in compliance with procedures to support process operations.
- Maintain inventory accuracy through cycle counting, reconciliation, and inventory controls.
- Author and revise warehouse-related SOPs and Quality Risk Assessments.
- Manage GMP-compliant storage of ambient, refrigerated, frozen, and cryogenic materials.
- Ensure compliance with GMP, GDP, safety, and quality requirements.
- Support deviations, impact assessments, investigations, CAPAs, audits, and inspection readiness activities.
- Coordinate with the central warehouse for incoming materials and oversee movements between the warehouse and manufacturing.
- Drive proper and effective use of the SAP system to reflect material movements.
- Foster a culture of safety, quality, and continuous improvement.
- Maintain a strong floor presence during GMP operations.
- Manage warehouse personnel, coach junior team members, and provide timely performance feedback.
- Provide off-hours, weekend, holiday, and on-call support after the site is operational.
Requirements
- Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or a related discipline with a minimum of 5 years of relevant experience, or a Master’s degree with a minimum of 3 years of relevant experience.
- Minimum of 5 years of experience in GMP-regulated warehouse operations, logistics, or supply chain.
- Working knowledge of warehouse material handling equipment, including forklifts, reach trucks, pallet jacks, and specialized equipment for GMP and temperature-controlled materials.
- Strong understanding of GMP requirements and experience handling cold chain materials and cold storage.
- Ability to train employees in technical, compliance, safety, and environmental procedures.
- Experience writing SOPs and managing warehouse deviations.
- Demonstrated initiative and ability to work effectively in a fast-paced environment.
- Willingness to support hands-on warehouse activities during escalations, startup activities, training, inventory events, and operational emergencies.
- Demonstrated experience operating forklifts, reach trucks, and other material handling equipment.
- Ability to drive and improve warehouse KPIs.
- Demonstrated ability to use SAP for warehouse-related functionalities and transactions.
- Ability to obtain and maintain certification for forklifts and other powered industrial trucks (PITs).
- Must be willing and able to lift up to 50 lbs, bend, scoop, squat, twist, climb steps, and don/wear required PPE.
Preferred Skills
- Experience with Lean methodologies or Veeva.
- Strong communication skills and experience with GMP materials.
- Ability to prioritize tasks and perform root cause analysis.
- Demonstrated attention to detail, ability to drive improvements, and inspire others.
- Continuous improvement mindset and willingness to challenge the status quo.
- APICS or similar certification.
Pay
The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
- Comprehensive medical, dental, and vision healthcare for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate, and sick days.