The incumbent will support the ongoing operation of the Manufacturing, Science and Technology team within the manufacturing site. This role will assist the receipt of technology transfers into manufacturing, and critical manufacturing support activities including investigations, change controls, CAPAs, process capability, capacity, electronic batch records, efficiency and quality improvements.
KEY ROLE AND RESPONSIBILITIES:
Equipment Identification, Qualification, and Support
- Work with a cross-functional team to ensure appropriate equipment selection and procurement.
- Facilitate equipment installation, commissioning, and qualification.
- Provide technical support of equipment during the onboarding phase and during ongoing operations.
Product, Process, and Technology Transfers and Changes
- Execute transfers of new products and processes to ensure smooth transition from process development into GMP manufacturing.
- Train Manufacturing staff as necessary on new unit operations and processes being transferred.
- Provide support for the MSAT team and cross-functional project teams in areas of facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
- Train MSAT engineers responsible for technology transfers and process troubleshooting.
- Assist in documenting changes/updates to manufacturing processes and work with cross-functional teams to implement those changes.
- Support the development, validation, and revision of electronic batch records as needed.
- Author and review, as necessary, sections of the regulatory documents and other communications to government authorities.
Investigations and Technical Support
- Provide technical support for deviation management, lot disposition, batch record reviews so that technical issues stay off the critical path for reliable supply.
- Provide real-time technical support to operations.
- Identify opportunities to implement operational excellence and continuous improvement.
- Maintain appropriate level of training for assigned responsibilities.
- Identify, communicate, and help mitigate identified risks that could negatively impact the quality or delivery of patient therapies.
- Assist with CAPA and change controls as needed.
- Build strong relationships with Quality to ensure a compliant manufacturing environment.
- Be a team player, offer assistance, and respond well to requests for help from team members.
- Use good communication and build relationships.
- Demonstrate technical acumen, operational understanding, and GMP compliance.
- Support operational excellence initiatives.
- Promote a culture of safety and GMP compliance.
- Identify opportunities for continuous improvement.
- BA/BSc with a minimum of 6 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing; or
- MBA or MSc with a minimum of 4 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing
- Minimum 2 years’ experience supporting cell or gene therapy manufacturing.
- Experience in technical roles within a GMP biopharmaceutical manufacturing operation, experience working in process development is a plus.
- Experience with manufacturing automation and MES software systems.
- Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge of USA and global regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, including requirements for clinical phase appropriate validation/qualification.
- Strong collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
- Proficient in MS Office and statistical software (R, JMP or Minitab).
- Proven ability to effectively lead projects in a fast-paced environment.
- Excellent written and verbal communication skills.
- Proven track record in a cGMP environment.
- 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.
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.