GMP Materials Management Associate

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 GMP Materials Management Associate (level determined by candidate experience) to work on-siteat our Germantown, MD location, to join us in our mission to serve patients with our next generation of innovative gene and 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 focused on the cGMP operations, while maintaining control and accuracy over all inventory.

Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.

DUTIES AND RESPONSIBILITIES :

• Manage activities and develop Materials Management Associate I staff.
• Perform materials management activities with cGMP compliance and support regulatory audit readiness.
• 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 Manufacturing, Quality Control, and Quality Assurance teams and inventory systems to ensure adequate materials are available and released in time to support GMP production.
• 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 Facilities, Manufacturing, Quality Control, and Quality Assurance in supporting internal and external materials management operations, and resolution of issues.
• Perform disposition of all expired materials and maintains applicable documentation.
• Monitor temperature conditions of refrigerators, freezers, and room temperature storage of cGMP materials.
• Generate Master Schedules and tactically ensure material supply supports forecasted production plans.
• Work closely with the internal departments to support lean inventory management and mean material demand needs.
• Drive continuous improvement of supplies, movement, and processes to reduce waste and improve service levels.
  
  

EDUCATION AND EXPERIENCE :

• Associate or Bachelor's degree in life science or supply chain management, or equivalent combination of education and experience.
• Minimum of 4 years’ experience in a regulated materials management environment.
• Knowledge of 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.
• Strong computer skills with Microsoft Office and the ability to quickly learn new applications.
• Experience with Inventory Management Systems/ERP and OE/5S is a plus.
• Technical working knowledge and/or experience in product packaging or design a plus.
  
  

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 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:
• Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies
• May need to work with hazardous materials
• Able to stand up to 4 hours at a time
  
  

EOE MFDV