Browse New and Exciting Opportunities

Process Development Senior Principal Scientist

Thousand Oaks, CA 91362

Posted: 07/02/2024 Employment Type: Contract Job Category: Scientific Job Number: 3880

Job Description

In this vital group leader role for the Pivotal Biologics, Drug Product Technologies group you will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. A key, and differentiating, responsibility of this role will be partnering with the DPT platform lead to progress the drug product platform, in addition to supporting pipeline program development.

Responsibilities:
  • Oversight of late-stage biologics drug product formulation and fill/finish process development.
  • Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development / characterization, technology transfer and regulatory authoring for pipeline and lifecycle management projects.
  • Lead all aspects of and engage in the planning, design, execution, and documentation of formulation and fill/finish process development studies.
  • Lead maintenance and expansion (as needed) of the core product-enabling platform knowledge assets that enable our product teams to deliver high-quality data packages and advance products through commercialization milestones.
  • Collaborate with DPTLs, unit op owners and process engineers to ensure platforms are serving the needs of product teams.
  • Provide guidance, feedback, and best practices to product teams on how to leverage the platform capabilities.
  • Ensure platforms and regulatory strategies maintain alignment, collaborating with UOOs and SME reviewers to close any gaps.
  • Measure performance of portfolio against platform targets and draw insights from fit to platform assessments and identify actions required.
  • Manage a team of engineers and scientists to advance program and functional objectives.
  • Participate and lead cross-functional teams working effectively in a highly matrixed team environment to motivate change, efficiency and strong relationships.
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of INDA and marketing application submissions.
  • Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
  • Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, strategy and future program and functional needs.
  • Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications:
  • Bachelor’s degree and 8 years of Scientific experience OR
  • Master’s degree and 6 years of Scientific experience OR
  • Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of Scientific experience

Preferred Qualifications:
  • Advanced degree in Engineering, Pharmaceutics, Biotechnology or Material Science.
  • 10+ years of post-PhD experience including elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.
  • Leadership of highly technical professionals with demonstrated results driving forward pipeline and lifecycle management programs.
  • Hands-on experience bringing new biotech products to market, across various dosage forms and device delivery systems.
  • Experience with advanced drug delivery for biologics including sustained release, nasal, pulmonary, or dermal delivery.
  • Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings.
  • Strong problem solving and effective cross-functional communication skills and ability to influence colleagues with ideas.
  • Previous scientific and managerial experience in support of drug product development, investigations and regulatory filing.
  • Ability to learn and act on dynamic information at a rapid pace.
  • Demonstrated track record of publication, patents and presentations.
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.