PRIMARY OBJECTIVE: This person is accountable for the continuous development and administration of Arcellx Quality Assurance which meets all compliance requirements. The incumbent should have experience with both manufacturing (GMP) and non-clinical QA (GLP), guidance documents and industry best practice.
ABOUT ARCELLX: Arcellx (http://arcellxdev.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The main responsibilities will include but are not limited to:
- Author, revise and review SOPs required to maintain the Quality Management System.
- Provide training to Arcellx personnel on the Quality Management Systems as required.
- Manage internal and external auditing program. Conduct GMP/GLP audits of internal departments, contract manufacturing organizations, outside testing laboratories, animal facilities, and other outside providers.
- Manage vendor qualification program.
- Lead batch disposition activities for the assigned manufacturing projects. Review of Batch Records and Laboratory Test Records and generation of documents needed for release e.g. COA, Animal Derivative Statement, Compliance Statement, Release Notification, etc.
- Lead investigations and CAPA program. Work with cross-functional teams to investigate quality events (deviations and quality incidents), CAPA implementation, closures and evaluate CAPA effectiveness.
- Perform trend analysis of Quality Event, internal and external audit finding and generate trend reports. Report trends identified to Quality Management and recommend CAPA and improvements to eliminate or decrease the risk/impact associated with the trends.
- Lead or be part of the quality team that is managing the manufacturing and testing facility commissioning, including facility validation, and equipment validation.
- Manage Quality Assurance department personnel.
- Lead and support various QA and cross-functional activities and projects, as needed.
- BS/MS in the life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology, related field.
- Experience in managing quality department personnel.
- 7-10 years of Quality Assurance experience in regulated industry (biotech); prefer experience with both manufacturing (GMP) and non-clinical QA (GLP).
- Minimum 5-7 years of experience conducting internal audits, vendor audits, leading investigations and lot disposition activities.
- Strong working knowledge in GMP/GLP regulations, including FDA and EMA guidelines applicable to biologics and cell therapy manufacturing.
- Able to work with cross functional teams, maintain good communication and relationship with all staff, contractor, and consultants.
- Able to independently interpret complex results and situations, recognize risk, and develop recommendations for solutions.
- Commitment to ethical scientific investigations and rigorous experimental methods.
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
- Demonstrated ability to think critically and analyze and interpret data independently.
- Sense of urgency in performance of duties.
- Interpersonal skills that promote a collaborative and productive lab environment.
- Effective and efficient written and oral communication skills.
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.