Principal Scientist, CMC Drug Product Development
About The Position
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn ( Xilio Therapeutics, Inc .). SUMMARY: The Principal Scientist, CMC Drug Product Development is a crucial role within Technical Operations with the responsibility for technical oversight of the drug product development and manufacturing operations at Xilio Therapeutics. The ideal candidate will have strong technical experience in biologics formulation and drug product development from candidate discovery through IND filing. This role will collaborate with internal cross-functional teams and external project teams and have a key role in supporting the Head of Technical Operations in developing expedited CMC development strategies.
Requirements
- Minimum of M.S. degree in science (e.g., biology, chemistry, pharmacy, medical, engineering or related field) with 8+ years of biologics drug product development or Ph.D. + 6 years of relevant experience
- Experience in formulation and drug product development for Biologics
- Experience working with external third-party vendors and/or biological contract manufacturing and the ability to execute CMC development projects
- Understanding of applicable regulations (cGMP, FDA regulations, PTC and guidelines, ICH guidelines, EU Guidelines, Applicable Pharmacopoeias)
- The ability to communicate effectively in a cross-functional team environment.
- Ability to work both independently with direction and within functional teams, to attain group goals
- Demonstrate strong organizational skills, including the ability to prioritize workload ability to pay close attention to detail and think strategically
Responsibilities
- Collaborate with Analytical Sciences on early formulation and developability studies
- Technical oversight of formulation and drug product development activities at CDMO(s), including determination of final dosage form and container/closure system
- Collaborate with Drug Substance Process Development on determination of appropriate formulation and storage conditions for drug substance
- Technical review and approval of CDMO generated drug product documentation, including but not limited to, development protocols/reports, master and executed batch records, stability protocols/reports, risk-assessments, deviations, change controls, and temperature excursions
- Person-in-plant (remote or in-person) for non GMP and GMP drug product manufacturing campaigns
- Oversight and coordination of clinical in-use studies, working with Clinical and Clinical Operations on study design and materials
- Work with key stakeholders to develop product supply plans and associated operational plans to ensure continuity of drug supply and materials availability
- Compile and/or review Drug Product related CMC sections for pre-INDs, INDs and other regulatory documents
- Cultivate and maintain external relationships with third party service providers
- Represent Technical Operations in cross-functional project meetings
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
