Crescent Biopharma
Sr / Principal Scientist, Analytical Sciences / Quality Control (AS/QC)
Crescent Biopharma, Bridgeport, Connecticut, us, 06610
Overview
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit crescentbiopharma.com and follow the Company on LinkedIn and X. Position Overview
Our Senior / Principal Scientist (AS/QC) will support analytical & formulation development as well as quality control activities related to the early phase development of bispecific monoclonal antibodies and antibody drug conjugates that are designed to be treatments for a variety of solid tumor indications. This individual will report directly to the Sr. Director of AS/QC and will serve as a key contributor in overseeing day-to-day CMC activities of CDMO partners, including review of raw data, release and stability data, drafting, review and approval of quality control SOPs, and participating in cross-functional meetings as the analytical/QC representative. This role is designed to provide scalable, phase-appropriate CMC support as the company advances its programs toward IND. Responsibilities
Analytical Sciences Collaborate with internal and CDMO partners to develop phase appropriate analytical methods to be used for the release and stability testing of our bispecific mAb and ADC products Oversee analytical method qualification at CDMOs Assist with troubleshooting method development, qualification and implementation at external CDMOs and CROs as needed Review and approve CDMOs method SOPs, reports and other documentation as required Review analytical, formulation and stability data Provide analytical support for formulation development, clinical in-use and other related studies at CDMO partners Quality Control Serve as QC point of contact for CDMO partners, ensuring appropriate quality control oversight of manufacturing campaigns Collaborate with CDMO/CRO partners to transfer, in a phase appropriate manner, methods for release and stability testing as needed Review and approve vendor batch records and other required documentation Generate COAs for DS/DP, collaborate with QA to facilitate batch disposition Maintain the internal Crescent stability program Monitor CDMO stability studies, review data and recommend shelf life/expiry dating for our products Review and approve vendor recommended changes to analytical method SOPs and related quality documentation Education & Experience
Bachelor’s or master’s degrees in Chemistry, Biochemistry, Pharmaceutical Sciences or related fields 12+ years’ experience in analytical and formulation development in the biopharmaceutical industry Demonstrated success developing, qualifying and transferring analytical methods Prior experience working in or collaborating with Quality Control Strong working knowledge of US FDA cGMP requirements for early-phase clinical programs Experience supporting clinical manufacturing and tech transfers preferred Excellent attention to detail, communication skills, and collaborative mindset Ability to thrive in fast-paced, dynamic environments Comfortable managing multiple priorities and engaging cross-functionally Strong commitment to quality, compliance, and continuous improvement Strong analytical, strategic thinking, and problem-solving skills What We Offer
Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment Competitive compensation, including base salary, performance bonus, and equity 100% employer-paid benefits package Flexible PTO Two, one-week company-wide shutdowns each year A commitment to your professional development, with access to resources, mentorship, and growth opportunities Equal Opportunity:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Research, Analyst, and Information Technology
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Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit crescentbiopharma.com and follow the Company on LinkedIn and X. Position Overview
Our Senior / Principal Scientist (AS/QC) will support analytical & formulation development as well as quality control activities related to the early phase development of bispecific monoclonal antibodies and antibody drug conjugates that are designed to be treatments for a variety of solid tumor indications. This individual will report directly to the Sr. Director of AS/QC and will serve as a key contributor in overseeing day-to-day CMC activities of CDMO partners, including review of raw data, release and stability data, drafting, review and approval of quality control SOPs, and participating in cross-functional meetings as the analytical/QC representative. This role is designed to provide scalable, phase-appropriate CMC support as the company advances its programs toward IND. Responsibilities
Analytical Sciences Collaborate with internal and CDMO partners to develop phase appropriate analytical methods to be used for the release and stability testing of our bispecific mAb and ADC products Oversee analytical method qualification at CDMOs Assist with troubleshooting method development, qualification and implementation at external CDMOs and CROs as needed Review and approve CDMOs method SOPs, reports and other documentation as required Review analytical, formulation and stability data Provide analytical support for formulation development, clinical in-use and other related studies at CDMO partners Quality Control Serve as QC point of contact for CDMO partners, ensuring appropriate quality control oversight of manufacturing campaigns Collaborate with CDMO/CRO partners to transfer, in a phase appropriate manner, methods for release and stability testing as needed Review and approve vendor batch records and other required documentation Generate COAs for DS/DP, collaborate with QA to facilitate batch disposition Maintain the internal Crescent stability program Monitor CDMO stability studies, review data and recommend shelf life/expiry dating for our products Review and approve vendor recommended changes to analytical method SOPs and related quality documentation Education & Experience
Bachelor’s or master’s degrees in Chemistry, Biochemistry, Pharmaceutical Sciences or related fields 12+ years’ experience in analytical and formulation development in the biopharmaceutical industry Demonstrated success developing, qualifying and transferring analytical methods Prior experience working in or collaborating with Quality Control Strong working knowledge of US FDA cGMP requirements for early-phase clinical programs Experience supporting clinical manufacturing and tech transfers preferred Excellent attention to detail, communication skills, and collaborative mindset Ability to thrive in fast-paced, dynamic environments Comfortable managing multiple priorities and engaging cross-functionally Strong commitment to quality, compliance, and continuous improvement Strong analytical, strategic thinking, and problem-solving skills What We Offer
Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment Competitive compensation, including base salary, performance bonus, and equity 100% employer-paid benefits package Flexible PTO Two, one-week company-wide shutdowns each year A commitment to your professional development, with access to resources, mentorship, and growth opportunities Equal Opportunity:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Research, Analyst, and Information Technology
#J-18808-Ljbffr