- Title: Senior QC Specialist
- Code: RCI-11815
- Location: Santa Monica, CA 90404
- Posted Date: 06/23/2022
- Duration: 6 Months
- Name:Rohit Sughani
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 293
Everyone at Company is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join us as a QC Research Associate III to support Company’s new, Cell Culture Ops at Santa Monica, California. The QC Research Associate III will be part of the Commercial QC Global Raw Materials and Reagents, COE, Cell Culture Operations team and will have the responsibility for helping to manage the execution of cell culture operations, planning, coordination, and operational activities in the QC laboratory.
In this exciting new role you will provide daily support for cell culture activities, analytical testing and sample management in support of commercial manufacturing of cell lines used as a method reference in testing of raw material, final drug product and stability testing of Cell Therapy products. You will also be responsible for the upkeep and maintenance of QC instrumentation and lab in GMP compliance.
Responsibilities for QC Research Associate III include:
- Assist managing the Company Global Raw Materials and Reagents Cell Culture Operations lab and oversee daily lab activities.
- Understand and execute protocols related to media and buffer preparation, cell culture and cell banking and other activities as needed.
- Accountable for the execution of routine testing like cell banking, PCR, Flow cytometry and ELISA.
- Manage samples and inventory related to each cell bank.
- Develop, revise and review SOPs.
- Provide necessary training and ongoing coaching.
- Establish user requirements for purchase, qualification of Company’s QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
- Provide updates at daily and weekly meetings and establish timely communication and escalation of issues to management.
- Adopt and implement Lean and six sigma lab concepts including setting up maintaining a Kanban system and 5-S program.
- Assist in regulatory inspections and interact with regulatory agencies and participate in inspections.
- Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents associated with testing.
- Assist managing and conduct lab investigations, write deviations, and own change controls.
- Other responsibilities as assigned.
- Master’s Degree in Molecular Biology/Biochemistry/Life Sciences 4+ years’ experience in the biotech/biopharmaceutical setting OR Bachelor’s Degree and 6+ years’ experience in the biotech/biopharmaceutical setting OR Associate Degree and 8+ years’ experience in the biotech/biopharmaceutical setting OR High School Degree and 10+ years’ experience in the biotech/biopharmaceutical setting
- 3+ years of cell culture or cell therapy manufacturing experience
- Experience in various cell and molecular biology methods: Flow cytometry, ELISA, PCR, cell-based assay, and other applicable methods in a Quality Control laboratory under GMP compliance.
- Knowledgeable of testing compendial methods (USP, Eur and JP Pharma Standards) and various QC analytical techniques including HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents.
- Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry is required.
- Possesses strong project and time management skills.
- Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace dynamic team setting.
- Exceptional attention to detail and ability to keep track of multiple ongoing projects
- Excellent communication and strong interpersonal skills are required
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning
- Comfortable in a fast-paced commercial environment with minimal direction and able to adjust workload based upon changing priorities
- The ability to accommodate occasional weekend work.
- Experience with implementing and maintaining lean, and six sigma concepts
- Familiarity with validation and technology transfer to internal and external analytical labs.
- Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control.
- Demonstrated ability to develop, coach, and mentor key employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment