Please see below for our current openings and email your CV to HR@sentienbiotech.com if you’d like to apply.

We are always looking for talented individuals to join our team, so even if you don’t see a job description below that is a good fit, we would still encourage you to reach out to us.

JOB TITLE:  DIRECTOR OF MANUFACTURING

DEPARTMENT:  Manufacturing

REPORTS TO:  VP Operations

SUPERVISES:  Process Engineering

The position manages all aspects of manufacturing, focusing on CMOs producing drug substance (cells) and drug product (biologic-device combination) for the company. The Director will develop a team to drive process engineering for future manufacturing needs through late-stage clinical trials and US commercialization. This requires tight collaborations with R&D, Quality and Regulatory to improve upon existing process and implement next-generation manufacturing.

GENERAL RESPONSIBILITIES:

  • Management of existing CMO producing cell banks and CMOs making biologic-device
  • Optimizes current processes and develops a next-generation process capable of supplying cells and final product for late-stage clinical trials and commercialization
  • Builds and leads a cross-functionally-minded team, dedicated to process engineering and manufacturing, that works seamlessly with key functional stakeholders.
  • Leads as the company’s main point of manufacturing expertise, contributing as a technical subject matter expert.
  • Has an unwavering appreciation of product integrity and patient safety, and can implement systems and processes throughout manufacturing to safeguard these values.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Knowledge of cGMP / ICH compliance regulations for manufacturing of cell therapies, primarily for the US / FDA market, with EU and Asian markets a bonus
  • Experience with cell culture techniques (2D & 3D), combination products (device-biologic), assays, release criteria, etc, including understanding of evolving standards and industry best practices.
  • Knowledge and experience with adherent cell cultures, ideally mesenchymal stromal cells
  • Intimate understanding of and experience with the discipline of process engineering
  • Ability to work in a fast-paced, small company environment
  • Highly organized, detail oriented, results driven and accountable for his/her team
  • Effective verbal and written communication skills, including high emotional intelligence
  • Ability to work in a collaborative group setting, and able to work with and through others
  • Willingness to travel

EDUCATION AND EXPERIENCE: 

  • BS/MS or PhD in degree in pertinent biologic or engineering discipline
  • 8+ years’ experience in developing and managing FDA-regulated (clinical or commercial) cellular GMP manufacturing
  • 8+ years’ senior management experience in the biopharma industry
  • 8+ direct years of relevant industrial and management experience in an FDA biologics regulated environment.
  • Experience in creating, or significantly contributing to, CMC sections of an IND or BLA

JOB TITLE:  SCIENTIST / SENIOR SCIENTIST, CELL THERAPY

The successful candidate will have scientific knowledge and demonstrated success in process development of cell therapy products including experience in adherent cell culture and cell behavior inside bioreactors.  Will lead certain aspects of product characterization, defining CQAs and CPPs.  This position has a laboratory-based component.

Other important qualifications include a commitment to scientific excellence, an appreciation for the balance between technology platform execution and development, and an ability to troubleshoot and solve problems.  The successful candidate must be able to independently manage the technical and strategic needs of their project(s), work productively with junior and senior colleagues, and be able to adapt to the changing needs of an early-stage company.  Excellent communication skills are also required.

QUALIFICATIONS:

  • Ph.D in Cell Biology or a life science with 3 or more years of experience the pharmaceutical and/or biotechnology industry
  • Familiar with conducting research within a quality management system, including documentation and experiments informed by design control / quality-by-design
  • Recent laboratory experience in adherent mammalian cell culture and cell behavior in bioreactors
  • Mesenchymal stem cell experience is ideal
  • Skilled in cell-based assay development
  • Ability to work in a small company environment, including making clear decisions in the face of ambiguity, conflicting deadlines, and changing priorities
  • Pre-clinical development and process development experience in cell therapy is desired
  • Experience in supervising a small team is a plus
  • Highly organized, detail oriented, results driven and accountable
  • Effective verbal and written communication skills, including high emotional intelligence
  • Ability to work in a collaborative group setting, and able to work with and through others
  • Ability to independently manage the technical and strategic needs of projects, and to concisely communicate results and recommendations. Project leadership experience is a plus.