Sr. Manager, Clinical Supply Chain
Watertown, MA
Technical Operations – CMC /
Full-time /
On-site
COMPANY INTRODUCTION
Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.
SUMMARY
Reporting to the Director, CMC, the Sr. Manager, Clinical Supply Chain will plan, build, and optimize clinical supply chain to ensure uninterrupted and timely clinical drug supply for Triveni’s clinical programs. The Supply Chain manager will oversee the packaging, labelling, and distribution activities, manage IRT systems as it pertains to drug product supply, and work collaboratively with clinical operations. The successful candidate will develop, implement, and optimize standardized processes and tools to support effective and efficient end to end planning of clinical trial materials.
RESPONSIBILITIES
· End to End clinical supply chain management with a focus on early-stage global clinical programs
· Work with the CMC team to oversee packaging, labelling, and distribution activities
· Participate in the creation and/or review of departmental SOPs and controlled documents to ensure compliance with cGMP and company SOPs.
· Manage inventories, shipping, and third-party manufacturers/ logistics providers
· Work with Regulatory Affairs, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations
· Maintain knowledge of current best practices of biological manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate.
· Generate global distribution plans, including depot inventory, site seeding, and re-supply strategy with appropriate lead-time, expiry dates, and replenishment quantities via IRT or manually
· Author, review, and/or approve related clinical and technical documents, including clinical label text, clinical/master batch records, clinical trial protocols, IBs pharmacy manuals, INDs, IMPDs, etc.
· Establish internal Supply Chain infrastructure to navigate and manage all planning, development and manufacturing related documentation and tools.
EXPERIENCE AND QUALIFICATIONS
· BS or MS in a relevant discipline
· A minimum of 5+ years of experience in clinical supply chain management for biologics in the biotechnology or pharmaceutical industry
· Experience supporting global clinical programs and understanding of operational requirements for international shipments strongly preferred
· Experience working cross-functionally with CMC, regulatory, clinical operations, and clinical development
· Experience managing contract development and manufacturing (CDMO) partnerships, CROs, and IRT vendors
· Understanding of cGMPs and relevant global regulations
· Familiarity with small start-up environments is strongly preferred.
· Team player that is able to think creatively and integrate perspectives from different functional areas.
· Strong leadership skills with demonstrated track record of success.
· Excellent oral and written communication skills.
Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.
