This position is responsible for maintaining Quality Systems that support the clinical manufacture of cell therapy products. The incumbent will assist in manufacturing batch record and deviations review, internal and contracted product release testing and reporting, and the revision of standard operating procedures and policies through change control. The QA specialist may also support process validations and material management efforts. This is a full-time position and will report to the Directory of Quality.
Position Role & Responsibilities:
- Support clinical production by ensuring compliance with regulatory and industry guidelines.
- Manage implementation of required changes with CMO to meet cGMP requirements and internal standards.
- Develop and manage effective working relationship with CMO personnel
- Review Manufacturing batch records and deviations
- Ensure adherence to Good Documentation Practices (GDP)
- Confirm accuracy in calculations and other reporting
- Prepare Documentation, Protocols and Standard Operating Procedures (SOPs).
- Revise Standard Operating Procedures
- Support Quality Control, Analytical Development, Process Development/Technology Transfer
- Facilitate internal and contract testing
- Assist in technology transfer documentation
- Support Operation and Process Qualifications
- Perform additional job-related duties as required
Education and Experience:
- Must be learned in cell biology and be proficient in cell culture in a product development or manufacturing environment.
- Must embrace positive, pro-active and “no-excuses” style of execution—must emanate ‘can-do’ attitude.
- Successful candidate must be willing to reside in San Diego County—must be willing to visit CMO site(s).
- Minimum of 3 years of relevant cGMP experience.
- Must be a person who enjoys new challenges in areas where prior guidance is not available.
- Experience in FDA regulations in cell therapy or biopharmaceuticals manufacturing
- Education: Bachelor’s degree in relevant science discipline is required
Additional Desired Skills and Knowledge:
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail oriented team player with effective planning, organization and execution skills.
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.