Principal Scientist, CMC Drug Product Development

Waltham, MA - USA

Monthly Salary: $ 163000 - 190000

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

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 visitingand 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.

Job 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

Skills Qualifications and 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

Equal Opportunity and Inclusion

Our human capital resources objectives include as applicable identifying recruiting retaining incentivizing and developing our existing and additional are committed to equal opportunity and inclusion across all aspects of our organization including in our recruitment advancement and development conduct annual performance and development reviews for each of our employees to discuss the individuals strengths and development opportunities career development goals and performance goals. We also regularly survey employees to assess employee engagement and addition each regular full-time employee is provided an allowance and time to attend appropriate job-related trainings and other professional development courses seminars meetings and similar sessions. If you are an individual with a disability who requires an accommodation with the hiring process please reach out to .

The pay range for this position is $163000-$190000. 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 candidates qualifications.

Required Experience:

Staff IC