Associate Director, Quality Analytics - Biotechnology
Managed by Jobot Pro
$130,000 - $150,000
A bit about us:
We bring together a breadth of technologies matched with deep knowledge of cancer-specific targets and TCRs to achieve the next advance in immunotherapy.
Why join us?
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. We offer partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.
- Ensures development of existing and new product analytics.
- Ensures raw materials are handled appropriately, from qualifying and interacting with vendors, to identifying CQAs and writing risk assessments, to identifying and developing testing procedures.
- Plans and develops testing strategies and processes for late-stage clinical development and commercial uses for companies’ cellular immunotherapy products.
- Contributes situational analysis support for business reviews and brand planning.
- Leads the synthesis of complex information, opportunity identification and development of conclusions and recommendations that can be used by management to make better business decisions and to identify opportunities and potential risks.
- Serves as a consultative, trusted advisor to business development and new product development leadership.
- Reviews and provides insight into master technical agreements with key testing vendors to provide compliant biological drug products for the clinical, launch and commercial phases.
- Supports business needs in a timely and efficient manner demonstrating a sense of urgency, tenacity and commitment to quality excellence.
- Provides strategic input to help shape the annual business plan, testing strategies, the launch plan, new product development plans, and development of key performance indicators.
- Communicates and shares findings with key management teams and across other groups as needed, effectively pulling through change within the broader organization.
- Bachelor’s or Master’s degree in Immunology or related scientific discipline, with a minimum of 8 years relevant experience in the cell or gene therapy field and 3 years of experience with biopharmaceutical late-stage clinical development and/or commercial QC.
- Proven background in leading testing strategies for product commercialization in the cell & gene therapy industry.
- Working knowledge in biopharmaceutical based GMP testing operations including experience in flow cytometry and qPCR.
- Working knowledge of raw material testing for late stage clinical development and/or commercial production.
- Experience in client, CMO, and vendor relationship management.
- Exceptional expertise and working knowledge of cGMP guidelines and knowledge of Quality System that meets global regulatory expectations.
- Understanding of industry trends and leading methodologies.
- Excellent communication and interpersonal skills.
- Trained in LEAN processes.