Climb Bio
Director Quality Control
About Climb Bio
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy, and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.
At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate. They reflect our commitment to patients, each other, and the pursuit of transformative science.
The Director of Quality Control (QC) will lead the development and execution of QC strategy for a growing biotech organization that relies exclusively on external manufacturing and testing partners. This role is responsible for building phase-appropriate QC programs, overseeing all analytical activities at CMOs/CDMOs and contract laboratories, and ensuring compliance with global regulatory requirements. The Director will serve as a key subject matter expert for QC, supporting regulatory submissions and driving quality excellence across external partnerships.
Key Responsibilities Strategic Leadership
Define and implement QC strategy aligned with company objectives and regulatory requirements.
Develop phase-appropriate QC programs leveraging external manufacturing and testing capabilities.
External Oversight
Manage and oversee all QC activities performed by third-party vendors, including in-process, release, and stability testing.
Act as the primary QC liaison for CMOs/CDMOs and contract testing laboratories.
Ensure timely review and approval of vendor-generated analytical data, certificates of analysis, and stability reports.
Technical Expertise
Provide QC subject matter expertise for investigations, deviations, and change controls related to external testing.
Oversee analytical method development, qualification, validation, and technical transfer at external sites.
Review and approve comparability study designs and reports to support process changes and regulatory filings.
Regulatory & Compliance
Author and review QC sections of regulatory submissions (IND, IMPD, BLA).
Ensure external vendors comply with GMP, ICH, FDA, EMA, and other applicable guidelines.
Participate in vendor audits and inspections, ensuring QC-related compliance and readiness.
Data & Specification Management
Establish and maintain product specifications for intermediates, drug substance, and drug product.
Develop stability protocols, review stability data, and recommend shelf-life for clinical trial materials.
Oversee stability programs at 3rd party vendors.
Cross-Functional Collaboration
Partner with CMC, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of QC activities.
Provide QC input for vendor selection, qualification, and ongoing performance monitoring.
Leadership & Continuous Improvement
Drive a culture of quality and compliance across external partnerships.
Identify and implement process improvements to optimize QC oversight and data integrity.
Qualifications
Bachelor’s degree in Chemistry, Biochemistry, Biology, or related scientific discipline required; advanced degree (MS or PhD) preferred.
Minimum 10+ years of experience in Quality Control or Analytical Development within the biotech or pharmaceutical industry.
Proven experience managing QC activities through external manufacturing and testing partners.
Strong knowledge of GMP regulations and global regulatory requirements (FDA, EMA, ICH).
Hands‑on experience with analytical method development, validation, and technical transfer.
Experience authoring QC sections of regulatory submissions (IND, IMPD, BLA).
Key Competencies
Excellent leadership and vendor management skills.
Strong analytical and problem‑solving abilities.
Ability to work in a fast‑paced, dynamic startup environment.
Exceptional communication and collaboration skills across internal and external stakeholders.
High attention to detail and commitment to data integrity.
Preferred Qualifications
Experience with biologic products.
Familiarity with phase‑appropriate QC strategies for clinical development.
Prior experience supporting regulatory inspections and audits.
Prior auditing experience is a plus.
This is a hybrid position and will be based out of our Wellesley, MA office. Base salary offered may vary depending on the individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.
Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, disability or any other federal, state, provincial or local protected ground.
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At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate. They reflect our commitment to patients, each other, and the pursuit of transformative science.
The Director of Quality Control (QC) will lead the development and execution of QC strategy for a growing biotech organization that relies exclusively on external manufacturing and testing partners. This role is responsible for building phase-appropriate QC programs, overseeing all analytical activities at CMOs/CDMOs and contract laboratories, and ensuring compliance with global regulatory requirements. The Director will serve as a key subject matter expert for QC, supporting regulatory submissions and driving quality excellence across external partnerships.
Key Responsibilities Strategic Leadership
Define and implement QC strategy aligned with company objectives and regulatory requirements.
Develop phase-appropriate QC programs leveraging external manufacturing and testing capabilities.
External Oversight
Manage and oversee all QC activities performed by third-party vendors, including in-process, release, and stability testing.
Act as the primary QC liaison for CMOs/CDMOs and contract testing laboratories.
Ensure timely review and approval of vendor-generated analytical data, certificates of analysis, and stability reports.
Technical Expertise
Provide QC subject matter expertise for investigations, deviations, and change controls related to external testing.
Oversee analytical method development, qualification, validation, and technical transfer at external sites.
Review and approve comparability study designs and reports to support process changes and regulatory filings.
Regulatory & Compliance
Author and review QC sections of regulatory submissions (IND, IMPD, BLA).
Ensure external vendors comply with GMP, ICH, FDA, EMA, and other applicable guidelines.
Participate in vendor audits and inspections, ensuring QC-related compliance and readiness.
Data & Specification Management
Establish and maintain product specifications for intermediates, drug substance, and drug product.
Develop stability protocols, review stability data, and recommend shelf-life for clinical trial materials.
Oversee stability programs at 3rd party vendors.
Cross-Functional Collaboration
Partner with CMC, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of QC activities.
Provide QC input for vendor selection, qualification, and ongoing performance monitoring.
Leadership & Continuous Improvement
Drive a culture of quality and compliance across external partnerships.
Identify and implement process improvements to optimize QC oversight and data integrity.
Qualifications
Bachelor’s degree in Chemistry, Biochemistry, Biology, or related scientific discipline required; advanced degree (MS or PhD) preferred.
Minimum 10+ years of experience in Quality Control or Analytical Development within the biotech or pharmaceutical industry.
Proven experience managing QC activities through external manufacturing and testing partners.
Strong knowledge of GMP regulations and global regulatory requirements (FDA, EMA, ICH).
Hands‑on experience with analytical method development, validation, and technical transfer.
Experience authoring QC sections of regulatory submissions (IND, IMPD, BLA).
Key Competencies
Excellent leadership and vendor management skills.
Strong analytical and problem‑solving abilities.
Ability to work in a fast‑paced, dynamic startup environment.
Exceptional communication and collaboration skills across internal and external stakeholders.
High attention to detail and commitment to data integrity.
Preferred Qualifications
Experience with biologic products.
Familiarity with phase‑appropriate QC strategies for clinical development.
Prior experience supporting regulatory inspections and audits.
Prior auditing experience is a plus.
This is a hybrid position and will be based out of our Wellesley, MA office. Base salary offered may vary depending on the individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.
Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, disability or any other federal, state, provincial or local protected ground.
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