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Company

Original Job Post

BioSpace · 2 days ago

Process Development Senior Principal Scientist

Thousand Oaks, CA

Full-time

Hybrid

Senior Level

10+ years exp

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Comp. & Benefits

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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.

Qualification

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Masters degree6 years Scientific experienceBiotechnologyDrug DeliveryFormulationAseptic ProcessingManufacturingGMPRegulatory FilingsProduct DevelopmentScientific ResearchProject ManagementPatentsLeadershipProblem SolvingCommunicationInfluenceAdaptability

Required

Bachelors degree and 8 years of Scientific experience OR

Masters 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

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.

Benefits

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible