Position: BioManufacturing Manager
Term: Full Time
Job Description/Key Responsibilities:
This role leads and manages GMP manufacturing as needed by the organization; writing and reviewing GMP documentation; training on GMP manufacturing operations; training of other associates; manufacturing, assembly, basic testing, packaging and shipping of products. Strong familiarity with the field’s concepts, practices, and procedures surrounding cell therapy. This position will contribute to the successful delivery of released product in support of clinical trials and commercial requirements. The Manufacturing Manager will work in different activities including manufacturing processes, facility cleaning, document review, inventory control and materials management.
- Manages the operations of all production areas to ensure that volume, cost, and quality standards are achieved.
- Plans and establishes work schedules, staffing requirements, and production sequences to maximize productivity.
- Leads the set up and administrating MRP software, along with ability to structure & produce Bills of Material
- Reads and follows work SOPs and schematics or receives verbal instructions regarding duties to be performed
- Works with executives, scientists, supervisors, and managers to improve quality and process efficiency
- Leads the set up and preparation of equipment for production runs in an aseptic environment.
- Participates in Quality Control inspections and Quality Assurance audits.
- Handle and deliver products and hazardous materials in compliance with all regulations and Company Policies.
- Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures.
- Trains other associates as needed
- Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management.
- Ensures that project/department milestones/goals are met and adhering to approved budgets.
- Works under minimal supervision
- Performs other duties as assigned
Travel Requirements: 10%
Subject to extended periods of sitting and/or standing in a clean room environment (ISO 7 or 5). Work is generally performed in an office, manufacturing clean room or clinical environment.
- College graduate (B.S. in Life Sciences/Biochemical/Bioengineering preferred)
- Five years of related manufacturing experience.
- Ability to communicate, receive and understand instructions regarding duties to be performed
- LEAN knowledge and application of LEAN principles.
- Demonstrated ability to follow instruction, SOPs, ability to communicate with co-workers and company leadership.
To Apply send resume and cover letter to firstname.lastname@example.org