Manager / Senior Manager (Small Molecule External Manufacturing)
Disc Medicine is looking for a CMC professional who will be responsible for the execution of process, formulation, analytical development, and cGMP manufacturing activities with focus on small molecules. This person will report into the Director of CMC and join a high-caliber CMC team that values a healthy, high-functioning workplace culture.
- Work with Contract Manufacturing Organizations (CMOs) to develop and qualify analytical methods in support of process development, stability studies, reference standard characterization, and GMP DS/DP release.
- Oversee analytical method transfer, qualification / validation, specifications, QC release, stability programs, and control strategies at CMOs.
- Ensure internal and external compliance with QA/QC in support of GMP DS/DP release.
- Partner with QA to develop phase appropriate control strategies, assist out of specification (OOS) and out of trend (OOT) investigations, implementation of technical improvements, CAPAs and change controls.
- Author and implement recommendations from guidance documents (FDA, EMA, ICH, and USP) towards lot release specifications, stability sections, batch release, and relevant manufacturing sections for IND and NDA submissions.
- Collaborate with internal functions such as quality, regulatory, supply chain, non-clinical, clinical, business development and project management to ensure alignment of program goals.
- Review and interpret analytical data, communicate results and findings at internal meetings and meetings with collaborators.
- Manage collaborations with key external consultants to ensure the relevant expertise is present for scientific discussions 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 (5-8 years) or PhD (3-5 years) in Pharmaceutical Sciences, Analytical Chemistry or equivalent. Candidate must have hands-on experience in a CMC focused role performing formulation and analytical development / qualification / validation in support of early and late-stage small molecule GMP campaigns.
- Proficiency in transfer of analytical methods with experience in physicochemical characterization and solid-state analysis of small molecules and dosage forms.
- Solid knowledge of principles of cGMP manufacturing involving small molecules, solid dosage forms and associated characterization methods.
- Experience writing CMC sections of IND, NDA, or other relevant regulatory submissions.
- Demonstrated understanding of the interdependencies of research, technical operations, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, and Regulatory CMC functions.
- 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.
- Develop and maintain effective working relationships with people across cultures and encourages collaboration across teams, vendors, and geographies.
- Respond resourcefully to changing business demands and opportunities.
- Ability to communicate and present results cross-functionally.
ABOUT DISC MEDICINE:
Disc Medicine is a biopharmaceutical company dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and financed by Series A lead investor Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture. Disc Medicine values communication, professional development, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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