Director/Senior Director, CMC

Job Description

Job Description

Salary:

Job Title: Director/Sr. Director

Reports To: VP, Antibody Engineering

Position:

Mediar Therapeutics is a clinical stage biotechnology company developing therapeutics to halt, or even reverse, fibrosis and restore long-term organ function. The platform and pipeline are based on an emerging class of novel targets- fibrotic mediators that play key roles in modulating myofibroblast biology and the development of fibrosis chronically damaged organs. Mediar was founded by Mass General Brigham Ventures, Massachusetts General Hospital and Brigham & Womens Hospital and has laboratory and office space in Boston.

We are seeking a candidate for Director/Sr. Director of CMC, who will be responsible for overseeing CMC and drug product manufacturing activities of new and existing clinical stage programs at external Contract Development and Manufacturing Organizations (CDMOs). Activities include but are not limited to upstream and downstream process design, formulation, scale up, technology transfer, process validation, and interpretation of data of varying complexity. In this cross functional role, he/she works directly with R&D, Clinical Operations, Supply Chain, Finance, Quality and Regulatory teams at Mediar as well as with external consultants, CDMOs and collaboration partners.

Role Responsibilities:

• Act as the CMC subject matter expert and manage external upstream and downstream development activities to support advancing product candidates in clinical studies
• Support technology transfer for manufacturing processes from CDMO to CDMO to facilitate scale up and late-stage development activities.
• Develop, review, and approve technical reports and controlled GMP documentation such as manufacturing batch records.
• Oversee efforts and work closely with CDMOs, Quality, Supply Chain, Regulatory CMC, and Analytical teams to ensure operational excellence, GMP compliance during manufacturing and timely release of drug product for clinical use.
• Provide technical support for change controls, process deviations, root cause identification and CAPA implementation associated with manufacturing deviations and quality events in a collaborative manner with Quality Assurance (QA).
• Develop phase-appropriate CMC development project plans with budgets and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
• Interpret complex data and make recommendations on process and formulation development directions.
• Contribute to drafting and reviewing of CMC documents for world-wide regulatory filings (IND, IMPD, etc.) and provide subsequent feedback as necessary to relevant agencies
• Maintain awareness of state-of-the-art manufacturing practices. Keep up with the latest regulatory and cGMP guidance.
• Develop and maintain strong relationships with CDMOs and participate in periodic business and technical review meetings with relevant CDMOs.
• Experience developing and implementing high concentration formulations for biologics is preferred
• Hybrid possible Onsite 2-3 days/ week

Required Qualifications:

• MS or PhD degree in Pharmaceutical Sciences, Pharm D., Chemical Engineering or related life sciences discipline.
• At least 10+ years of hands-on experience in biotherapeutic upstream and downstream process development. 8-10 years experience with Ph.D.
• Thorough knowledge of cGMP, regulatory requirements, and approaches for implementation of Quality by design (QbD) principles, Design of Experiments (DoE) in DP development, process validation.
• Ability to work successfully in a team/matrix environment and independently, as required.
• Pragmatic, solution-oriented thinker with excellent verbal and written communication, and strong interpersonal and organizational skills.

Mediar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other classification protected under applicable law. Mediar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.