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Manufacturing Associate I
The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations.
KEY ROLE AND RESPONSIBILITIES:
Startup Facility and Operations
- Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences on all aspects of facility qualification and start-up.
- Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations.
Execute the Day-to-Day Manufacturing Processing
- Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
- Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
- Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
- Maintain appropriate level of training for assigned responsibilities.
- Work with TechOps teams to execute technology transfers and capacity building projects.
- Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
- Use strong communication and teamwork skills to build relationships across the manufacturing site.
- Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
- Support operational excellence initiatives, and the implementation of new technologies and systems.
- Ensure a strong culture in safety and GMP compliance
- BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)
- 0 - 2 years of experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
- Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
KNOWLEDGE, SKILLS AND ABILITIES:
- Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
- Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
- Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
- The desire and ability to work in a fast-paced, start-up environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
- Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.