Xilio Therapeutics
Principal Scientist, CMC Drug Product Development
Xilio Therapeutics, Waltham, Massachusetts, United States, 02254
Principal Scientist, CMC Drug Product Development
Waltham, Massachusetts
Xilio Therapeutics is a clinical‑stage biotechnology company discovering and developing tumor‑activated immuno‑oncology therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current 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 at http://www.xiliotx.com.
Summary The Principal Scientist, CMC Drug Product Development, is a crucial role within Technical Operations with responsibility for technical oversight of 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 collaborates with internal cross‑functional teams and external project teams and supports the Head of Technical Operations in developing expedited CMC development strategies.
Job Responsibilities
Collaborate with Analytical Sciences on early formulation and developability studies
Provide 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
Perform technical review and approval of CDMO‑generated drug product documentation, including development protocols/reports, master and executed batch records, stability protocols/reports, risk assessments, deviations, change controls, and temperature excursions
Serve as person‑in‑plant (remote or in‑person) for non‑GMP and GMP drug product manufacturing campaigns
Oversee and coordinate 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
Build and maintain external relationships with third‑party service providers
Represent Technical Operations in cross‑functional project meetings
Skills, Qualifications, and Requirements
Minimum of an M.S. degree in science (e.g., biology, chemistry, pharmacy, medical, engineering or related field) with 8+ years of biologics drug product development experience, or a Ph.D. with 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
Knowledge of applicable regulations (cGMP, FDA regulations, PTC and guidelines, ICH guidelines, EU guidelines, applicable pharmacopoeias)
Strong communication skills in a cross‑functional team environment
Ability to work independently with direction and within functional teams to attain group goals
Strong organizational skills, including the ability to prioritize workload, pay close attention to detail, and think strategically
Equal Opportunity and Inclusion We are committed to equal opportunity and inclusion across all aspects of our organization, including recruitment, advancement, and development practices. We do not discriminate on the basis of any protected group status under any applicable law.
Compensation The pay range for this position is $163,000–$190,000. This pay range represents a good faith estimate of the annual salary for this role. Final compensation may be higher or lower depending on the candidate’s qualifications.
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Xilio Therapeutics is a clinical‑stage biotechnology company discovering and developing tumor‑activated immuno‑oncology therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current 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 at http://www.xiliotx.com.
Summary The Principal Scientist, CMC Drug Product Development, is a crucial role within Technical Operations with responsibility for technical oversight of 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 collaborates with internal cross‑functional teams and external project teams and supports the Head of Technical Operations in developing expedited CMC development strategies.
Job Responsibilities
Collaborate with Analytical Sciences on early formulation and developability studies
Provide 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
Perform technical review and approval of CDMO‑generated drug product documentation, including development protocols/reports, master and executed batch records, stability protocols/reports, risk assessments, deviations, change controls, and temperature excursions
Serve as person‑in‑plant (remote or in‑person) for non‑GMP and GMP drug product manufacturing campaigns
Oversee and coordinate 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
Build and maintain external relationships with third‑party service providers
Represent Technical Operations in cross‑functional project meetings
Skills, Qualifications, and Requirements
Minimum of an M.S. degree in science (e.g., biology, chemistry, pharmacy, medical, engineering or related field) with 8+ years of biologics drug product development experience, or a Ph.D. with 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
Knowledge of applicable regulations (cGMP, FDA regulations, PTC and guidelines, ICH guidelines, EU guidelines, applicable pharmacopoeias)
Strong communication skills in a cross‑functional team environment
Ability to work independently with direction and within functional teams to attain group goals
Strong organizational skills, including the ability to prioritize workload, pay close attention to detail, and think strategically
Equal Opportunity and Inclusion We are committed to equal opportunity and inclusion across all aspects of our organization, including recruitment, advancement, and development practices. We do not discriminate on the basis of any protected group status under any applicable law.
Compensation The pay range for this position is $163,000–$190,000. This pay range represents a good faith estimate of the annual salary for this role. Final compensation may be higher or lower depending on the candidate’s qualifications.
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