Xilio Therapeutics, Inc. · 8 hours ago
Principal Scientist, CMC Drug Product Development
Waltham, Massachusetts
Full-time
Hybrid
Senior Level, Lead/Staff
$163K/yr - $190K/yr
6+ years expXilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies. The Principal Scientist, CMC Drug Product Development will oversee drug product development and manufacturing operations, collaborating with various teams to support expedited CMC development strategies.
BiopharmaBiotechnologyHealth CareOncologyTherapeutics
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
Qualification
Required
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
Benefits
An allowance and time to attend appropriate job-related trainings and other professional development courses, seminars, meetings, and similar sessions.
Company
Xilio Therapeutics, Inc.
Xilio is a Waltham, Massachusetts-based clinical-stage biopharmaceutical company focused on defeating cancer.
51-200 employees
H1B Sponsorship
Xilio Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$294.3MKey Investors
Rock Springs CapitalTakeda VenturesF-Prime
2025-06-02Post Ipo Equity· $50M
2024-03-28Post Ipo Equity· $11.3M
2021-10-22IPO
Leadership Team
Rene Russo
President and Chief Executive Officer
Fraser Leslie
Senior Vice President
Recent News
2025-11-15
Xilio Therapeutics, Inc.
2025-11-14
Company data provided by crunchbase