Materials Management Manager

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

We are seeking an experienced Materials Management Manager at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative cell therapies. This position will require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will be responsible for all aspects of materials management and flow, while maintaining control and accuracy over all inventory.

DUTIES AND RESPONSIBILITIES:

• Lead the materials management program and management of supporting staff and their development.
• Perform hands-on materials management operations including, ordering, receiving, inspecting, dispositioning, and stocking of raw material and supplies for cGMP manufacturing of cell and gene therapy products.
• Work with Facilities, Manufacturing, Quality Control, and Quality Assurance teams to support local GMP and non-GMP activities.
• Coordinate and ship products, samples, and ensure temperature sensitive material reach their destinations on time and in full.
• Create and/or update raw material/supplies specification as well as develop or modify SOPs for material management processes, as necessary.
• Organize storage rooms, perform cycle counts, data entry to maintain a cGMP inventory system thus ensuring all our departments have adequate access to the materials they need.
• Implement and maintain strict GMP procedures and lead any efforts required to address and close any material deviations or non-conformance.
• Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external cGMP compliant operations, regulatory audit preparedness.
• Perform disposition of all expired materials and maintains applicable documentation.
• Support Facilities with the management of refrigerators, freezers, and room temperature storage of cGMP materials.
• Work closely with the Planning/Buying team and suppliers to ensure efficient material throughput supporting local activities.
• Drive continuous improvement of supplies, movement and processes to reduce waste and improve service levels.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in life science or supply chain management.
• Minimum of 6 years’ experience in a regulated materials management environment.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
• Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries.
• Experience with regulatory audits of cGMP manufacturing sites.
• Technical working knowledge and/or experience with materials across CRT, 2-8C, -20C and <-80C required.
• Experience with validated ERP system for cGMP environment required. Experience with ERP implementation is preferred.
• Excellent computer skills with Microsoft Office and the ability to quickly learn new applications.

DESIRED KEY COMPETENCIES:

• Comfortable in a fast-paced company environment and able to change direction easily to accommodate the situation at hand, while maintaining a positive attitude.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Highly motivated with excellent interpersonal, collaborative and team-oriented skills to work well with the rest of the organization and build relationships with suppliers.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Strong quantitative and analytical skills.
• Ability to understand and execute on the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits and open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.
• Working conditions and physical requirements:
  1. Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies
  2. May need to work with hazardous materials
  3. Able to stand up to 4 hours at a time

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

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