Lead Quality Control CAR T
4 weeks ago
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
Job Description:
This individual will hold a pivotal role in delivering Cell therapy products with the highest quality and will fit into a dynamic Quality Control team. This individual will be responsible for the line management of QC specialists responsible for the introduction of novel products and testing in QC. The scope of accountability encompasses both clinical and commercial supply and includes testing of In-process analytics, finished products, raw materials including starting and critical raw materials and stability testing.
The QC Lead will assess the impact of changes and deviations regarding analytical activities and will supervise analytical method validation and tech transfer activities performed by the team. At the same time, the job holder will represent the Quality Control function in all CMC workstreams including specification setting, stability management, manufacturing process technology transfer and qualifications.
Lead the QC Cell therapy team (Flow Cytometry, Molecular Assay qPCR/ddPCR, Bioassay, Cytokine detection, Functional assay & ELISA and Rapid Microbial detection methods) by supporting, coaching and developing team members in reaching quality, business and personal objectives.
Coordinate project planning, timeline, communications, and risk management activities.
Leads the design, development and implementation of department strategies and contributes to the strategic planning for the CAR-T functional area.
Establish and maintain effective working relationships with business and quality partners to ensure alignment of objectives and deliverables.
Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance.
Author, review and approve where necessary SOPs.
Reference standard and stability strategy establishment.
Support Cell therapy manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies.
Anticipate and address issues in manufacturing related to process, documentation, or training.
Provide technical input and investigation support for deviations/OOS.
Assist in the management of changes, and in the implementation of process improvements.
Provide technical input in support of regulatory filings and submissions.
2+ years of relevant experience as a product owner supporting a lab-based LIMS.
Evaluate and assist in statistical design and execution of comparability assessments for cell therapy products.
Review regulatory filings summarising the technology transfer and comparability strategy and results.
Contribute to alignment and harmonization of strategies across multiple stakeholders (e.g Manufacturing, QC, CMC-PD, Quality and RA).
Experience and Technical skills required
Expert knowledge of global cell therapy and logistics along with a comprehensive understanding of facility/clean room architecture, process, equipment, automation, and validation.
Prior experience with Human cell handling, Cell and Gene therapy processes, quality attributes, product control strategy, analytical method life cycle management, trending and regulatory submissions.
Line management experience.
Prior experience with LIMs and SAP is preferred.
Understanding and competency in DoE study design
Experience leading quality and regulatory inspections (e.g DCGI, USFDA and EU).
Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
Experience in in-process characterization/testing of cell therapy/Biologics manufacturing processes.
Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a cross functional team-based environment are required.
Behavioral skills:
Leadership: Effectively lead and motivate a team of MSAT to achieve departmental goals and objectives.
Communication: Clearly communicate with team members, other departments, and management to ensure efficient workflow and collaboration.
Problem-Solving: Ability to analyze complex manufacturing science/processes and technology issues and develop effective solutions to ensure accurate testing and compliance with regulations.
Decision-Making: Make clear and timely decisions to address challenges and drive the department towards success.
Teamwork: Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes.
Time Management: Prioritize tasks, meet deadlines, and ensure timely completion of projects while maintaining quality standards.
Qualifications
Qualifications:
Ph.D. degree or Master's degree or Bachelor's degree in Biology, Chemical Engineering, Microbiology, Biotechnology with 10 - 15 years of experience in working on Cell and Gene therapy (CAR-Ts) and Biological Products.
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