Crescent Biopharma , Inc.
Director / Senior Director, CMC Drug Product
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. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Position Overview We are seeking an accomplished CMC professional to oversee formulation development, drug product (DP) development, and manufacturing for our pipeline of biologics and ADCs. Within the Technical Operations Team, this role will help build CMC strategy and deliver technical leadership across all stages of drug product development, from IND‑enabling activities through late‑stage process validation and commercialization. The ideal candidate offers extensive subject‑matter expertise and has a history of effective program management and external CDMO oversight.
Responsibilities
Lead formulation, DP development, and manufacturing strategy for biologics and ADCs
Direct DP efforts from early phase development through process characterization, validation and commercial launch
Provide technical guidance across liquid, lyophilized, and high‑concentration DP formats
Oversee CDMO DP manufacturing operations and function as the primary point of contact
Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives
Serve as a key subject matter expert contact for both internal teams and external partners
Prepare and review CMC sections for regulatory submissions (IND/IMPD/BLA)
Coordinate CMC activities with Quality, Regulatory, and Clinical functions to ensure alignment with development and regulatory goals
Promote continuous improvement and uphold GMP, data integrity, and compliance standards
Support budgeting, vendor selection, and contract management of CDMO partners
Champion a collaborative, diverse, and inclusive team environment
Education & Experience
Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
At least 8 years’ experience in formulation development, DP development, and external CDMO manufacturing
Demonstrated leadership in manufacturing development, including hands‑on experience and person‑in‑plant exposure
Expertise in developing liquid, lyophilized, and high‑concentration drug product formulations
Experience working with ADCs is highly preferred
Comprehensive understanding of GMP, ICH guidelines, and regulatory requirements for biologics and ADCs
A track record of innovation, problem‑solving, and ability to deliver high‑quality work supporting Company objectives
Outstanding communication and leadership skills, capable of influencing across organizational levels
Ability to excel in fast‑paced environments and manage multiple priorities
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.
Pay Transparency The anticipated base pay range for this position is:
The anticipated salary range for candidates for this role at the Director level is $223,000 – $246,000 and at the Senior Director level is $260,000-$288,000. 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.
Equal Opportunity Employer 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 accomplished CMC professional to oversee formulation development, drug product (DP) development, and manufacturing for our pipeline of biologics and ADCs. Within the Technical Operations Team, this role will help build CMC strategy and deliver technical leadership across all stages of drug product development, from IND‑enabling activities through late‑stage process validation and commercialization. The ideal candidate offers extensive subject‑matter expertise and has a history of effective program management and external CDMO oversight.
Responsibilities
Lead formulation, DP development, and manufacturing strategy for biologics and ADCs
Direct DP efforts from early phase development through process characterization, validation and commercial launch
Provide technical guidance across liquid, lyophilized, and high‑concentration DP formats
Oversee CDMO DP manufacturing operations and function as the primary point of contact
Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives
Serve as a key subject matter expert contact for both internal teams and external partners
Prepare and review CMC sections for regulatory submissions (IND/IMPD/BLA)
Coordinate CMC activities with Quality, Regulatory, and Clinical functions to ensure alignment with development and regulatory goals
Promote continuous improvement and uphold GMP, data integrity, and compliance standards
Support budgeting, vendor selection, and contract management of CDMO partners
Champion a collaborative, diverse, and inclusive team environment
Education & Experience
Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
At least 8 years’ experience in formulation development, DP development, and external CDMO manufacturing
Demonstrated leadership in manufacturing development, including hands‑on experience and person‑in‑plant exposure
Expertise in developing liquid, lyophilized, and high‑concentration drug product formulations
Experience working with ADCs is highly preferred
Comprehensive understanding of GMP, ICH guidelines, and regulatory requirements for biologics and ADCs
A track record of innovation, problem‑solving, and ability to deliver high‑quality work supporting Company objectives
Outstanding communication and leadership skills, capable of influencing across organizational levels
Ability to excel in fast‑paced environments and manage multiple priorities
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.
Pay Transparency The anticipated base pay range for this position is:
The anticipated salary range for candidates for this role at the Director level is $223,000 – $246,000 and at the Senior Director level is $260,000-$288,000. 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.
Equal Opportunity Employer 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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