Senior Manager/Associate Director, CMC

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.

The Role:

Triveni Bio is seeking a highly-motivated and collaborative Senior Manager/Associate Director, CMC to join our organization. Reporting to the Director, CMC, the successful candidate will be involved in managing all aspects of CMC development for Triveni’s pipeline of monoclonal and bispecific antibodies; including, lead selection, process/analytical development, drug substance/drug product manufacturing, clinical supply chain, and CMC operational planning. This is an exciting, high visibility role for an individual looking to have an outsized impact on a growing organization advancing multiple therapeutic candidates to address novel disease targets.

Key Responsibilities:

• Provide broad CMC support for internal programs from lead candidate selection through clinical manufacturing and supply. Support includes both internal initiatives and management of development and manufacturing activities at CDMOs.
• Coordinate with internal and external quality assurance, quality control, and regulatory team members as necessary throughout development, manufacturing, and clinical supply
• Represent CMC within internal cross-functional development teams and collaborate with team members to identify and mitigate risks and roadblocks for pre-clinical/clinical production
• Prepare CMC regulatory filing sections (domestic and international) including drafting and review of supporting documentation
• Partner with Director, CMC to develop CMC strategy; including, short- and long-range planning to support Triveni’s therapeutic candidates and CMC organizational growth.
• Develop and maintain collaborative relationships with internal stakeholders to deliver on Triveni goals and objectives (e.g. discovery, Non-Clinical, CMC, Clinical, Regulatory, Quality, Operations, etc.)

Qualifications:

• BS/MS or PhD in a relevant scientific/engineering discipline
• A minimum of 5 years - 7 years of relevant experience in the biotechnology or pharmaceutical industry (direct experience in Biologics Required)
• Hands-on experience in at least one area of the CMC lifecycle: Process Development, Manufacturing (Drug Substance and/or Drug Product), MS&T, Analytical Development/QC, CMC project management, and/or Supply Chain. Experience in more than one functional area strongly preferred.
• Experience managing contract development and manufacturing (CDMO) partnerships strongly preferred
• Knowledgeable in early to late phase regulatory pathways. Experience authoring CMC sections of regulatory submissions such as INDs and IMPDs strongly preferred.
• Team player and self-starter that is able to think creatively and integrate perspectives from different functional areas
• Experience working in small company environments strongly preferred
• Ability to influence with indirect authority
• Excellent oral and written communication skills
• Ability to work in the US and willing to travel both domestically and internationally as required