Quality Control Scientist (Biological Assay Development Scientist)
Mountain View, CA 94040
Must be a US Citizen or Green Card holder.
The Quality Control Scientist will be a member of the Quality Control Department. As a Senior Member of the team he or she will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
- Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients.
- Support routine GMP testing as assigned. Mentor and train team members
- Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements.
- Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports.
- Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data.
- Identify, evaluate, and implement continuous business process improvements.
- Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS).
- Provide support during laboratory investigations.
- Train QC personnel during method transfer and validation. Provide support during equipment qualification.
- Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices.
- Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures.
QUALIFICATIONS:
- B.S in any scientific field; MS/Ph.D. in Analytical Biological Assay preferred
- 8-10 years of experience in the areas of method development, validation, and transfer
- Demonstrated experience in Quality Control laboratories for biotechnology products.
COPETENCIES/CANDIDATE PROFILE:
- Direct GMP Experience
- Proficiency in project management skills and tools
- Strong background and in-depth knowledge in Analytical Biological Assay e.g. Flow Cytometry, ELISA, PCR, etc.
- Must have extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs, Mycoplasm, Cell based assays, Flow Cytometry (BD, Miltenyi), 8 Colors Staining.
- Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required.
- Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
- Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team.
- Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.
- Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external.
Supervisory Responsibility:
Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing
Minimum Required Training:
Must be familiar with GMP lab environment and Aseptic techniques.
Working Environment:
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays, or overtime and as required by the company
- May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
- Must have the ability to work with specialized equipment
- Must be able to handle the standard/moderate noise of the manufacturing facility
- May work with hazardous materials and chemicals
Physical Requirements:
- Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear
- The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance)
- Heavy cryo-gloves must