Obsidian Therapeutics is seeking an Associate Director of QC Operations to support manufacturing with a critical CDMO partner for their clinical trials in metastatic melanoma and non-small cell lung cancer. The ideal candidate will have experience directing and overseeing QC of drug product manufacturing completed at a CDMO from clinical to commercial, preferably in cell and/or gene therapy.
Requirements
- Bachelor's degree in biology, chemistry, life sciences or a related field, and 10+ years of analytical experience in biologics or CGT in an industry setting (or M.S. and 8+ years of experience)
- At least 6 years of experience in a GMP setting
- Expertise with analytical method transfer and phase appropriate validation/qualification
- Familiarity with relevant FDA/EMA and ICH regulatory guidelines relevant to gene and cell therapy, analytical development, and method validation
- Experience enabling and overseeing contract test laboratories for cell and/or gene therapy products and managing quality events and investigations
- Experience with late phase to commercial programs (cell therapy, gene therapy or biologics)
- Experience with QC analytical methods optimization and troubleshooting for cell and gene therapy products including potency assay, immunoassays/flow cytometry, PCR, etc.
- A clear sense of ownership and accountability to meet commitment and high standards promoting the same with CDMO partners
- Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment
- Excellent organizational skills, with a proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans
- Flexibility - ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient
- Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns
- A track record of context-based sound judgement, including when to elevate risks and issues to leadership
- An ability to be on-site at CDMO up to 30-40% of time
- Collaborative and accountable – recognizes success requires interdisciplinary thinking and teamwork; shares feedback and ideas, productively challenges own and others’ assumptions to facilitate better outcomes
- Self-motivated, with a proven ability to work with general direction to meet objectives and timelines, managing multiple responsibilities in parallel
- Curious and humble – seeks and welcomes input/expertise of others, continuous learner
- Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments
- Operates with urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners.
- Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives.
- Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose; reflective and self aware.
Benefits
- Comprehensive medical, dental, and vision coverage
- Company contributions to health savings and retirement accounts
- Ample paid time off
- Access to wellness programs
- Rich career growth opportunities
