Current Openings

We are seeking a Principal Scientist to join the Analytical Development / CMC team. The successful candidate will work in multi-disciplinary teams in a fast paced environment to advance pre-clinical and clinical programs at Tarveda. The Principal Scientist will be responsible for execution of internal and outsourced analytical activities spanning pre-clinical research, clinical program development, and will oversee key GMP regulated activities from initial feasibility and technology transfer through analytical method validation, material release, and stability testing. A solid understanding of GMP regulatory law and guidance, compendia, and common industry practice in the US and EU is an advantage. The successful applicant will manage analytical activities for key manufacturing and research vendors (CMO and CTL) to ensure the quality and timeliness of their work while building a strong business relationship. The ideal candidate will have experience developing Phase 1/2 stage drugs, a strong background in chemistry and analytical methodology, and excellent communication and organizational skills.

Key Responsibilities:

  • Proven ability to collaborate with peers and effectively work in an energized, fast-paced and cross-functional results oriented research team environment to deliver the objectives of Tarveda in a timely and cost efficient manner that meets quality requirements. Excellent written and verbal communication skills. Able to work independently and as part of a group.
  • Normally receives broad instructions on routine and new work. Self-motivated, and able to drive own work and that of managed vendors.
  • Deep understanding of underlying science and analytical methodologies common to the pharmaceutical industry (e.g. HPLC, GC, KF, process chemistry) to provide technical expertise towards assay development, product development, quality control, and troubleshooting.
  • Technical project leadership and lab contributions, spanning multiple initiatives in small-molecule analytical development and CMC support.
  • Technical and project management of GMP manufacturing and testing vendors’ analytical / QC work, maintaining clear and efficient business relationships with vendors.
  • Contribution to strategy and execution relevant to pre-clinical and phase 1 & 2 clinical programs
  • Design, perform and lead internal and external analytical work supporting product development, characterization and understanding for process chemistry drug substance, drug product, and key raw materials and intermediates.
  • Oversight and execution of analytical feasibility and technology transfer activities, methods validation, material release and stability, OOS/OOT investigations, etc. as required at CMO and CTL vendors.
  • Author SOP, methods, protocols, reports, CoA, and contribute to regulatory submissions.
  • Coordinate closely with Quality, Process Chemistry, Drug Product Formulations, and management to provide project updates, workflows, and timelines/budgets.
  • Responsible for activities that impact company timelines and corporate goals.
  • Some travel required, less than 10%.

Experience:

  • 5+ years of CMC experience with Ph.D or 8+ years with B.S./M.S. is required.
  • Established background in analytical development, and technical QC GMP experience.
  • Experience with vendor management of CMOs and/or CTLs for Drug Substance and Drug Products (Parenteral) programs is strongly preferred.
  • Experience in the management & mentorship of more junior scientific staff.
  • Experience working with early-phase oncology programs is an advantage.

Qualifications:

  • B.S. with an M.S. or Ph.D. in applicable science field; chemistry preferred.

Please send your resume and cover letter to careers@tarveda.com

Equal Opportunity Employer

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