Lead Manufacturing Associate (Upstream)
Location: San Diego, CA
Typical Duties Include
- Perform work in a cGMP manufacturing environment.
- Operate in a Class 10,000 and Class 100,000 rooms.
- Perform cell vial thaw and flask expansion inside a Bio-Safety Cabinet (BSC) as well as generating Cell Banks for clients.
- Operate and maintain equipment designed for single-use technology as it relates to cell culture such as the GE RTP WAVE 25 and Sartorius STR Systems (50 L to 2000 L).
- Conduct activities in support of production schedules as directed by senior staff.
- Determine necessary supplies, know how/where to obtain and stock supplies, when needed.
- Prepare media supplementation and salt solutions for cell culture production.
- Maintain GMP records to comply with regulatory requirements and assist with in-process testing.
- Work is performed independently.
- Trains all operators on activities prior to GMP execution.
- Write, revise and approve SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.
- Support and direct floor operations for multiple projects simultaneously.
- Initiate deviations, assess product quality impact, propose and execute Corrective and Preventative Actions (CAPA).
- Perform manufacturing and process development activities for projects and products in collaboration with others.
- Provide training to new personnel for Upstream technical processes and equipment.
- Represent departmental activities as needed, including project teams, training, and evaluation of new technologies.
- May cross-train on various tasks including Downstream cGMP manufacturing and PD processes as needed to support overall success of the Biologics group.
- Monitor processes and results to ensure project success.
- Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results, and suggest methods to ensure process success.
- Review completed batch records daily for GMP compliance and completeness.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed to attend professional conferences, train on new technologies or travel between GMP facilities.
- Work requires occasional days of more than the standard eight-hour shift, and weekend duty.
- BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related field.
- Minimum 5 to 10 years of experience in a GMP pharmaceutical or biotech environment.
- Knowledge and skill with aseptic handling required, including BSC operations to maintain the integrity of open cell culture operations.
- Expert knowledge of mammalian cell culture processes.
- Knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
- Skill using single-use technologies, including tube welding, tube sealing, and disposable systems.
- Ability to follow detailed instructions and to maintain accurate records.
- Ability to communicate and delegate skills to effectively coordinate floor operations with staff.
- Organizational skills to prepare team for operating multiple projects.
- Ability to successfully multitask, when required.
- Ability to troubleshoot cell culture operations, preferred.
- Ability to safely operate production equipment in accordance with established practices.