Crescent Biopharma , Inc.
Director / Senior Director, Biologics CMC
Crescent Biopharma , Inc., Waltham, Massachusetts, United States, 02254
About Us
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. Visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Position Overview We are seeking an experienced CMC leader to oversee GMP development and manufacturing activities for biologics executed at external CDMOs. This individual will serve as the program CMC lead, directing end-to-end process and manufacturing strategy, execution, and compliance across all development phases. The ideal candidate must possess strong technical expertise in downstream protein purification, complemented by demonstrated program management and vendor oversight experience.
This role places significant emphasis on downstream purification, including chromatography development, filtration strategies, viral clearance, and UF/DF process robustness across all phases.
Responsibilities
Provide deep technical leadership in downstream purification operations, including chromatography (capture, intermediate, and polishing), filtration, and UF/DF.
Lead downstream process characterization, scale‑up strategy, resin lifetime studies, and impurity clearance evaluations.
Troubleshoot purification performance issues such as aggregation, low yield, impurity breakthrough, or filtration bottlenecks.
Provide overall CMC leadership for assigned biologics programs, including bsAb and ADC molecules, from development through clinical and commercial manufacturing.
Oversee CDMO activities and serve as the primary technical and strategic interface between internal teams and external partners.
Deliver expert guidance on purification process design, optimization, and troubleshooting to ensure robust, scalable processes.
Monitor process development, MSAT, and manufacturing timelines to ensure timely, high‑quality execution aligned with program goals and budgets.
Manage CDMO performance and proactively address technical or operational issues.
Coordinate with Quality, Regulatory, and Clinical functions to align CMC activities with development and regulatory strategies.
Prepare and review CMC sections of regulatory submissions (IND/IMPD/BLA).
Promote continuous improvement and ensure adherence to GMP, data integrity, and compliance requirements.
Support budgeting, vendor selection, and contract oversight for external manufacturing activities.
Provide technical leadership within a lean, collaborative team environment.
Education & Experience
Ph.D. or M.S. in Biochemistry, Chemical Engineering, Biotechnology, or related field.
Minimum 10 years of industry experience in biologics process development and GMP manufacturing, including substantial CDMO oversight.
Strong expertise in purification/downstream process development; experience in upstream, formulation, or fill‑finish is desirable.
Extensive experience in late‑stage and commercial manufacturing, including PC, PPQ, and PAI readiness.
Demonstrated ability to lead CMC strategy and operations in a small or virtual biotech setting.
Comprehensive knowledge of GMP, ICH guidelines, and regulatory expectations for biologics.
Strong communication, organizational, and problem‑solving abilities.
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.
The anticipated salary range for candidates for this role at the Director level is $219,000 – $243,000 and at the Senior Director level is $259,000-$286,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑and long‑term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found through the link below. https://www.crescentbiopharma.com/careers/#benefits
E-Verify:
Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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.
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Position Overview We are seeking an experienced CMC leader to oversee GMP development and manufacturing activities for biologics executed at external CDMOs. This individual will serve as the program CMC lead, directing end-to-end process and manufacturing strategy, execution, and compliance across all development phases. The ideal candidate must possess strong technical expertise in downstream protein purification, complemented by demonstrated program management and vendor oversight experience.
This role places significant emphasis on downstream purification, including chromatography development, filtration strategies, viral clearance, and UF/DF process robustness across all phases.
Responsibilities
Provide deep technical leadership in downstream purification operations, including chromatography (capture, intermediate, and polishing), filtration, and UF/DF.
Lead downstream process characterization, scale‑up strategy, resin lifetime studies, and impurity clearance evaluations.
Troubleshoot purification performance issues such as aggregation, low yield, impurity breakthrough, or filtration bottlenecks.
Provide overall CMC leadership for assigned biologics programs, including bsAb and ADC molecules, from development through clinical and commercial manufacturing.
Oversee CDMO activities and serve as the primary technical and strategic interface between internal teams and external partners.
Deliver expert guidance on purification process design, optimization, and troubleshooting to ensure robust, scalable processes.
Monitor process development, MSAT, and manufacturing timelines to ensure timely, high‑quality execution aligned with program goals and budgets.
Manage CDMO performance and proactively address technical or operational issues.
Coordinate with Quality, Regulatory, and Clinical functions to align CMC activities with development and regulatory strategies.
Prepare and review CMC sections of regulatory submissions (IND/IMPD/BLA).
Promote continuous improvement and ensure adherence to GMP, data integrity, and compliance requirements.
Support budgeting, vendor selection, and contract oversight for external manufacturing activities.
Provide technical leadership within a lean, collaborative team environment.
Education & Experience
Ph.D. or M.S. in Biochemistry, Chemical Engineering, Biotechnology, or related field.
Minimum 10 years of industry experience in biologics process development and GMP manufacturing, including substantial CDMO oversight.
Strong expertise in purification/downstream process development; experience in upstream, formulation, or fill‑finish is desirable.
Extensive experience in late‑stage and commercial manufacturing, including PC, PPQ, and PAI readiness.
Demonstrated ability to lead CMC strategy and operations in a small or virtual biotech setting.
Comprehensive knowledge of GMP, ICH guidelines, and regulatory expectations for biologics.
Strong communication, organizational, and problem‑solving abilities.
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.
The anticipated salary range for candidates for this role at the Director level is $219,000 – $243,000 and at the Senior Director level is $259,000-$286,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑and long‑term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found through the link below. https://www.crescentbiopharma.com/careers/#benefits
E-Verify:
Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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.
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