QC Team Lead AnalyticalNetherlands - HoofddorpQualityRegular
Job Description QC Team Lead Analytical
As the Team Lead for QC analytical you will be responsible for line management, supervision and coordination of a group of QC analysts (8-12 analysts) whose primary goal is to test commercial and clinical in-process samples, final drug product, incoming goods and stability samples.
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As the Team Lead for QC analytical you will be joining a team in which people of all backgrounds and experiences are respected, and where working together while being focused on saving lives by finding the cure for cancer is a daily activity.
The QC analytical group is part of the Quality Control department. The Quality Control department ensures consistent quality throughout the manufacturing process by providing accurate testing of Incoming Goods, in-process samples, final product, environmental monitoring, and stability samples. The team is diverse, enthusiastic and hard working.
You will be reporting to the Manager of QC Analytical.
In this role, you will lead a group of QC analysts, whose primary goal is to test in-process samples and final drug product while ensuring total cGMP compliance. The team lead will manage all resources (analysts, equipment, batches, documentation) to ensure timely delivery of high quality analytical testing and reporting.
You will be involved in improvement projects of the lab and designing the processes that will make the QC laboratory more efficient and compliant as well as participate in building a team of qualified individuals. Due to the nature of the product and speed of treatment, this role requires a high level of proficiency and ownership of the process.
Your responsibilities, among others, will be:
- Lead one of the QC analytical groups (approx. 8-12 analysts)
- Act as an advisor and technical resource to your team
- Coordinate and perform training of new personnel and manage training records for the QC analytical group
- Coordinate and work with the team to troubleshoot issues and provide solutions
- Organize and prioritize daily tasks to ensure an efficient process and timely analysis of batches
- Monitor the GMP systems currently in place to ensure compliance with documented policies and safety regulations
- Lead investigations and supporting continuous improvement initiatives
- Write, review and/or implement deviations, change controls and CAPAs
- Write, review and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.)
- Act as a SME during audits and Regulatory Inspections
- Interact with other departments and within QC in a professional manner and join in applicable meetings.
- Support other groups within QC to reach the departmental goals
- Perform other duties as required by QC management.
Challenges of the Role
- Working in a fast-paced environment: coordination of large number of batches with tight timelines.
- Maintain compliance and safe working environment despite time pressure.
- Take part in developing the QC department, documentation, processes and culture.
The ideal candidate has a can-do attitude and thrives in a fast-paced environment. Because the QC group is involved daily with multiple departments, a strong ability to communicate and coordinate is essential to ensure a smooth and efficient process. The ideal candidate should possess a technical mind but is also able to think outside the box in order to use logic and sound judgement to provide solutions to problems.
- A BSc degree and minimum 6 years of experience in the Biotech and/or Pharmaceutical Industry
- Full working knowledge of GMPs, pharmacopoeia and regulatory requirements.
- Proficient in application of QC principles, concepts, industry best practices and standards
- Management, organization and prioritization skills
- Strong interpersonal skills and willingness for team work
- Previous hands-on experience in a QC lab capacity
- Proficiency in quality control systems, methods and procedures for routine and non-routine analysis of raw materials
- Experience at performing and concluding investigations
- Experience in writing and implementing deviations, change controls and CAPAs
- Experience in writing or updating SOPs and analytical methods
- Strong verbal and technical writing skills (English)
- Experience with participating in audits (regulatory, customers, inter-organizational)
- Willingness and ability to work in shifts (day shifts, including Saturdays and Sundays)
- Can-do attitude
- Hands-on, roll up your sleeves mentality
- Comfortable in a fast-paced environment with minimal direction
- Ability to adjust workload based upon changing priorities
- Strong organizational skills
- Team player
- Excellent communication skills
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.
Only candidates in possession of a valid EU work permit will be considered.