
QC Specialist II
Netherlands - HoofddorpQualityRegularОписание вакансии
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Kite Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. We are a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp).
Department Description
As QC Analytical Senior Technician (QC specialist II), you will be joining a team in which people of all backgrounds and experiences are respected. Together we are focused on saving lives, by finding the cure for cancer, as a daily activity.
You’ll be reporting to the Team lead QC Analytical.
Your challenge
As a QC Analytical Senior Technician, you will keep an overview of the lab and keep track of equipment issues, completion of documentation, OOS handling, deviations, planning, repeat assays and high invalid rates. You will analyze all kinds of samples (raw material, in process, final product and validation samples). You will execute qualification and validation of analytical methods. Due to the nature of the treatment this role requires high level of proficiency and ownership of the process, with the highest skill level of accurate and sterile techniques. You will be able to develop yourself by revising and reviewing SOP's and make a substantial contribution to our treatment and the growth and development of Kite Pharma.
Responsibilities (include but are not limited to)
- Perform testing of raw material, in process, final product and validation related samples
- Review test results
- Keeping overview in the lab and adjusting the planning if needed for business continuity
- Oversight in batch release testing overview for QC Analytical
- Participate in Tech Transfer of (Bio) Analytical methods, during the transfer of new product
- Execute qualification/validation of (Bio)Analytical methods
- Participate in SOP updates
- Perform lab investigations regarding out of specifications (OOS) results and deviations related to QC Analytical and incoming goods testing procedures
- Troubleshoot instrumentation/ test methods
- May serve as a technical resource within the department as well as cross-functionally
- Participate in routine maintenance of lab equipment and lab spaces
- Coordinate waste management and perform other duties as required
- Upkeep of the GMP in the lab
Qualifications
- Bachelor’s degree in Analytical Chemistry/ Molecular Biology or equivalent preferred with at least 5 years of QC experience in the Biotech and/or Pharmaceutical Industry
- Proficiency in Molecular Biology, Analytical and/or Biochemical testing techniques required in determining the quality and efficacy of parenteral products, preferably with reference to cell therapy products (e.g., Cell Culture/ Flow Cytometry/ ELISA/ qPCR/ ddPCR).
- Working knowledge of cGMP, GLPs, Pharmacopoeia, regulatory requirements for testing and validation pertaining to the Pharmaceutical Industry
- Understanding of testing techniques required in determining the quality and efficacy of parenteral products preferably with reference to cell therapy products.
- Proven investigation skills and technical writing skills
- Proficiency in Microsoft Office applications
- Strong interpersonal, verbal, and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
- Additional requirements:
- Ability to be flexible to work in shifts, flexible with your schedule, and work overtime as needed