Quality Control Bioanalytical, Manager
San Francisco + Competitive Salary + Growth Opportunities!!!
A newly partnered CRO and Clinical stage immuno-oncology company are looking to expand their Quality team in their new location in South San Francisco to assist in the commercialization of cell and gene therapies and vaccines!
Manage, direct, and evaluate bioanalytical testing activities of the Quality Laboratory to ensure the safety of products and to comply with quality and regulatory requirements. Work independently with teams from GMP Manufacturing, Process Development, Quality Assurance, and Manufacturing Science and Technology (MSAT) to assist GMP Manufacturing facilities.
If you're looking for the step up in your career and have the drive to move forward, then apply for the position of Quality Control Bioanalytical, Manager today!
Responsibilities
- Oversee QC bioanalytical testing services provided to our clients, in support of process development, product manufacturing, product release, and stability evaluation.
- Scheduling day-to-day operations of bioanalytical testing, personnel, and equipment to ensure support of development and clinical manufacturing runs
- Review of records of testing and studies performed by the QC Bioanalytical group to assure accuracy, completeness, and in conformance with the applicable procedures and regulatory compliance.
- Manage the technical transfer and qualification of analytical procedures for clients, including commissioning and qualification of laboratory equipment and instruments used in the QC Bioanalytical laboratory.
- Implementation and maintenance of QC laboratory quality systems and assure their area of responsibilities comply to those systems, including deviation and OOS investigations, CAPA implementation, and change control.
- Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits.
- Ensure adherence to cGMP practices for QC laboratory operations and testing performed by the QC Bioanalytical staff.
- Set individual goals and objectives for QC personnel in alignment with the department, the company, and client goals
- Fosters an empowering environment where team members develop innovative solutions that improve performance and gain team support for change to achieve optimal productivity and proficiency
- Establish expectations for collaboration within the team and model effective collaboration; supports collaborative efforts with other teams and departments and build strong partnerships that lead to improved results
The ideal candidates will have:
- Bachelor's Degree in Biochemistry, biological sciences, or related field
- 8 years of relevant field experience
- 2 years of Supervisory Experience
- Flow Cytometry, PCR, Immunoassays, and Bioassays
Benefits will include:
- Tuition reimbursement
- LCIO
- Upward mobility
Does this sound like you? Apply today!
