QC Senior Specialist, Data Analytics & LIMS

Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

QC Senior Specialist – QC Tech Services Data Analytics & LIMS

We are seeking a highly motivated individual to join the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will help provide Quality Control oversight of commercial manufacturing of final drug product. You will be working on data analytics and compliance for bioanalytical methods for cell therapy products and improvement projects.

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.

Department Description

As Senior Specialist for QC Tech Services you will be joining a team in which people of all backgrounds and experiences are respected, and in which working together while being focused on saving lives by finding the cure for cancer is a daily activity.

The QC Tech Services 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 responsible for QC trending, querying data, reporting, visualization of QC data and LIMS business requirement implementation. Additionally, you will work on projects and support efforts in automation development.

You will be reporting to the Associate Director of QC Tech Services.

Your Responsibilities

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:

• Improve/automate the data, metrics and KPI trending and visualization (dashboarding) of data within the QC department.
• Query writing to support data analytics.
• Participate and Collect improvement opportunities and assoc in the global Kite LIMS enhancement forums.
• Represent TCF04 in the global LIMS meetings.
• Support inititated requirements for the business and escalate to the appropriate global working team.
• Plan, Coordinate and lead site specific LIMS project deliverables.
• Support best practices on LIMS development, reporting and any other configuration.
• Obtain cross-functional alignment on LIMS related project requirements and resources to facilitate implementation and ongoing support.
• Lead/Participate in the cross-functional data analytics board within Kite NL.
• Generate and support dashboards for monthly, quarterly and annual data trending.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Act as SME during audits and Regulatory Inspections.
• Perform other duties as required.

Challenges of the Role

• Working in a fast-paced environment
• Maintain compliance and safe working environment despite time pressure.
• Take part in developing the QC department, documentation, processes and culture.
• Global meetings (no 9 to 5 work schedule)

Your Profile

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.

Education

• A BSc degree and minimum 5 years of experience as LIMS Specialist in the Biotech and/or Pharmaceutical Industry.

Knowledge/Experience

Required:

• 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 to engage in teamwork
• Experience at performing and concluding investigations
• Experience with data management systems (LIMS, Power BI, JMP, SQL Query)
• Experience with Query writing
• Experience in writing and implementing deviations and CAPAs is a pre.
• Experience in writing or updating SOPs
• Strong verbal and technical writing skills (English)
• Experience with participating in audits (regulatory, customers, inter-organizational) is a pre.

Personal skills

Required:

• 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
• Flexibility
• Non 9 to 5 mentality
• 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.

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