Current Openings

Tarveda Therapeutics, Inc. is a clinical stage biotechnology company that discovers and develops Pentarins™, a new class of potent and selective miniaturized drug conjugates with enhanced targeting capabilities for the treatment of solid cancer tumors. Tarveda’s lead Pentarin drug candidate, PEN-221, is a miniaturized drug conjugate that targets the somatostatin receptor 2 (SSTR2) for treatment of patients with neuroendocrine and small cell lung cancers. PEN-221 comprises a highly selective peptide that targets SSTR2 linked to the potent cytotoxic DM1 through a cleavable linker.

Tarveda is also advancing its HSP90 drug conjugate platform with lead drug candidate PEN-866, which is a miniaturized HSP90 targeting drug conjugate that comprises a small molecule HSP90 targeting ligand conjugated to SN-38, the highly potent, active metabolite of irinotecan. Tarveda’s strategy includes developing its own proprietary Pentarins as well as applying the Pentarin platform to enhance the effectiveness of the targeting moieties and novel payloads of pharmaceutical collaborators.

Position Summary:

Tarveda is seeking a Drug Product Development Leader, CMC who will lead drug product development and external GMP manufacturing for clinical trial material. The successful individual will work in multi-disciplinary teams in a fast-paced environment to advance drug development at Tarveda. In this position, you will be responsible for strategy and execution of drug product development and manufacturing, including: communication and management of GMP suppliers, technology transfer, scale-up, process development, and GMP manufacturing of drug product to support clinical studies.

Additionally, in this position you will contribute significantly towards achieving company timelines and corporate goals by driving drug product development and manufacturing to deliver clinical trial material meeting program demands from phase 1 through to commercialization. Experience developing investigatory drugs, a strong background in GMP manufacturing and drug development, and excellent communication and organizational skills are required.

Essential Functions:

  • Manage drug product vendors towards successful technology transfer, process development, scale-up, and manufacturing of GMP drug product for clinical use. Ability to coordinate and contribute towards vendor contracts, quality agreements, and negotiations.
  • Author, revise, and approve project documents, including: manufacturing batch records, SOP, study protocols, technical reports, specifications, CTD sections, deviations, change control, etc.
  • Review completed Manufacturing documents and drive batch disposition.
  • Contribute significantly towards drug production planning and strategy. Proactively identify program risks, recommend solutions, drive informed decision-making, and communicate project status with relevant critical details to stakeholders and team members.
  • Lead planning and execution of phase-appropriate development studies (in-house and external) and manufacturing activities.
  • Vendor management.
  • Approximately 5% travel internationally.

Education and Experience:

  • Bachelor’s degree in chemistry, chemical engineering, pharmaceutics or related discipline within pharmaceutical sciences; Master’s degree preferred.
  • 10 years’ experience working in GMP regulated drug development and manufacturing is required. Must be well versed with regulatory law and guidance, compendia, and common industry practice in the US and EU for early and late phase development programs.
  • Experience in managing outsourced activities at international CMOs.
  • Experience with aseptic filling; lyophilization is required.
  • Excellent planning, organizational, verbal & written communication skills.
  • Ability to think intuitively and problem solve.
  • Experience working in a fast pace, small, start-up environment requiring the management of multiple and shifting priorities. Experience working with early-phase oncology programs is an advantage.

Required Competencies:

  • Ability to think intuitively and problem solve
  • Team oriented
  • Effective communication (written and verbal)
  • Detail oriented
  • Independent
  • Results oriented
  • Multi-tasking
  • Strong sense of urgency

Tarveda Therapeutics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Please send your resume and a brief cover letter describing why you should be considered for the position to the careers@tarveda.com

Tarveda Therapeutics, Inc., 134 Coolidge Ave., Watertown, MA
Website: www.tarveda.com