Senior Scientist/Manager, Chemistry, Manufacturing and Control (CMC)
This position is responsible for the execution of CMC plans to support nonclinical and clinical development of Disc Medicine’s portfolio pipeline, which includes monoclonal antibodies and small molecules. The position reports into the Director of CMC.
Work with Contract Manufacturing Organizations (CMOs) to design, execute and finalize processes towards process development, analytical methods, stability protocols, reference standard characterization, and GMP DS/DP release
Oversee processes involving analytical method qualification, technology transfer and GMP manufacturing readiness at CMOs
Review batch records, protocols, development, and manufacturing reports; manage their timely execution and approval
Ensure internal and external compliance with quality and process attributes (CQAs/PQAs) in support of robust manufacturing operations
Contribute to the development of phase appropriate control strategies, out of specification and out of trend investigations and implementation of technical improvements
Collaborate with Disc Medicine internal functions such as quality, regulatory, non-clinical, clinical, business development and project management; ensure alignment of program goals
Review and interpret CMC data; communicate results and findings at internal meetings and meetings with collaborators
Author sections of the CMC modules in support of regulatory submissions
Manage collaborations with key external consultants to ensure the relevant expertise is present for scientific discussion and decision-making; seek alignment on development, manufacturing, and regulatory expectations
Identify industry trends and propose innovative solutions that support compliance and operational excellence
MS in Pharmaceutical Sciences or equivalent. Candidate must have 5 to 8 years of experience in developing processes, methods and manufacturing unit operations including direct hands-on experience with antibodies and small molecules.
Experience in both start up biotech and large pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions.
Solid knowledge of principles of cGMP manufacturing and guidance documents from FDA, EMA, ICH, and USP.
In-depth understanding of process, analytical and formulation development with relevant exposure to statistical data analysis.
Must have ability to independently design and facilitate execution of technical experiments/protocols with an emphasis on high quality outcome.
Strong problem-solving, troubleshooting and written/oral communication skills.
Develops and maintains effective working relationships with people across cultures and encourages collaboration across teams, vendors, and geographies.
Responds resourcefully to changing business demands and opportunities.
ABOUT DISC MEDICINE:
Disc Medicine is a Series A biotechnology company, formed as an Atlas Venture seed company in October of 2017 with the intent of discovering new medicines for hematological disorders with a specific focus on the discovery and development novel therapies for the treatment of hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and is supported by a panel of advisors with a strong track record of discovering and developing new and innovative therapies.
In October 2019, Disc Medicine Completed a $50 Million Series A Financing led by Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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