Associate Director/Director, CMC
About Climb:
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 are seeking a highly motivated Associate Director/Director, CMC based at our corporate headquarters in Wellesley, MA. Reporting to the VP of CMC, this is a pivotal role in ensuring progression of our biologics pipeline from IND enabling work through clinical development across USA, EU and APAC.
Key Responsibilities
- Oversee the execution of Chemistry, Manufacturing, and Controls (CMC) work across a global CDMO network—from cell line development to bulk drug substance, tech transfer and scale-up, drug product manufacturing, quality control, and stability testing.
- Review and approve technical documents such as process development protocols/reports, batch records, deviations, analytical qualification protocols and reports.
- Partner with Quality and Regulatory Affairs to implement and monitor quality control systems and regulatory compliance measures in accordance with FDA and other applicable guidelines.
- Develop and execute supply chain strategies to ensure timely procurement of raw materials and distribution of clinical supplies.
- Oversee inventory management and shipping logistics for drug products and critical materials, ensuring timely delivery and supporting clinical trial timelines.
- Manage contract review, negotiation, and execution with vendors, suppliers, and contract manufacturers to secure optimal terms and performance.
- Collaborate closely with Non-clinical and Clinical Development, Regulatory Affairs, Quality, and Finance Departments to ensure the seamless advancement of projects.
- Serve as the primary liaison with external partners and internal teams, fostering clear communication and coordinated action across all functions.
Qualifications:
- Advanced degree (Ph.D. or M.S.) in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 8 years of experience in biologics/gene therapy CMC roles within the biopharmaceutical industry.
- Demonstrated experience as a CMC technical lead with hands-on experience managing CDMOs.
- Knowledge of global regulatory requirements (FDA, EMA and NMPA), GMP, and ICH guidelines.
- Exceptional problem-solving and communication skills, and the ability to operate in a collaborative and fast-paced environment.
- Candidates with technical expertise in more than more areas are encouraged to apply, e.g. process development and/or analytical/formulation development.
This position will be based out of our Wellesley, MA office and candidates are expected to come on-site at least 3 days per week to collaborate with the team.
Base salary offered may vary depending on individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.
Qualified candidates are encouraged to forward their resumes to [email protected]
Climb Bio 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, and disability or any other federal, state, provincial or local protected ground.