Your Role:
Responsible for daily supervision of eight to ten assigned team of hourly MM Associates within a GMP warehouse and manufacturing environment. The team's duties include but, are not limited to receiving, storage, picking, packing, shipping, filling of internal reservations, and inventory management. Most activities are performed in an ambient environment but, there are some activities that are performed in 2-8 C, and -20 C environment and work with -30c, -73c and -135c freezers. Some activities occur in a high bay warehouse. This role requires knowledge of each of the areas and technology which is used for assigned work group.
Essential Duties and Responsibilities:
- Supervise, train, and coach materials management associates to develop a high performing and diverse team capable of supporting 24/7 commercial LV manufacturing and CGT manufacturing.
- Provide daily supervision of all general warehouse functions to include receiving, put away, stock replenishment, picking, packing, shipping, and basic inventory transactions in a GMP environment.
- Lead the material management team to operate in a safe and compliant manner at all times.
- Assign daily tasks and adjusts resources throughout the day based on workload and operational priorities.
- Troubleshoot inventory, equipment, and system issues to identify resolution, as needed, escalates issues effectively to supporting functions.
- Lead team huddle, approve vacations, and provide first level support to staff on escalated issues.
- Author and edit Standard Operating Procedures (SOPs) as needed.
- Lead corrective actions associated with deviations and audit findings.
- Provide daily status reports and metrics as directed to manager with recommendations on ways to improve performance if needed.
- Act as a subject matter expert on all processes, equipment, and procedures.
- Ensure appropriate levels of packaging supplies are maintained, and work areas are organized.
- Lead continuous improvement for warehouse operations through Yellow Belt, Green Belt, and 5S initiatives.
- Support and lead operational tours associated with client, internal, and regulatory audits.
- Manage commercial drug substance freeze-down, storage, cell bank storage, distribution and shipment to clients.
- Help client audits for the Materials Management organization, serving as the subject matter expert.
- Support FDA regulatory inspections and ensuring GMP compliance with no critical observations within the department.
- Other duties as assigned.
Requirements:
- High school diploma/equivalent and 5+ years as an individual contributor; 5 years' experience in warehousing or warehouse activities.
- 3 years experience in lead roles (People or Projects).
- 4 years' experience in ERP (SAP MM preferred).
- 4 years' experience in GMP and/or ISO environment.
Knowledge / Skills / Abilities:
- Excellent organizational and leadership skills.
- Proficient in SAP, or other ERP systems.
- Proficient in Microsoft Office.
- Experience in GMP environment.
- Continuous improvement training.
- Working knowledge and understanding of GMP, GCP, GDP, and other regulatory requirements.
- Working knowledge and understanding of Quality management system likes: Trackwise, QUMAS, QLIMS, Veeva, Master Controls and ENNOV.
- Ability to communicate effectively in English (both written & verbal) in order to ensure understanding of SOPs and safety requirements.
- Ability to work across functional disciplines.
- Ability to adapt in a constantly evolving environment.
- Self-motivated with a strong sense of ownership in areas of responsibility.
- Ability to lead team members.
- Customer service oriented.
- Ability to solve problems quickly.
Physical and Mental Demands:
- Ability to organize/coordinate
- Comprehend and follow instructions
- Direct, control and plan solve
- Analyze/Interpret data and information
- Problem Solve
- Make decisions using sound judgment
- Perform with frequent interruptions
- Good eye/hand coordination
- Use keyboard/computer/phone
- Maintain stationary position
- Repetitive movement activities
- Reaching
- Position self to move
- Move/Transport [50] lb.
Work Environment:
- Regular and predictable attendance
- Work around extreme temperatures (cold or hot)
- Travel Requirements: 0-5% travel requirement (Domestic sites only)
The hiring range for this position is expected to fall between $75,516-$88,914/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.
