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Company

Original Job Post

BioSpace · 3 days ago

Process Development Principal Scientist

Thousand Oaks, CA

Full-time

Hybrid

Senior Level

7+ years exp

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Comp. & Benefits

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Responsibilities

Lead all attribute and analytical aspects of a small molecule program in pivotal clinical process development while working cross-functionally within a Product development team

Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization

Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites

Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities

Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification

Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development

Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies

Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff.

Qualification

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Masters degreeScientific experienceChromatographic TechniquesSpectroscopic TechniquesProcess Analytical TechnologiesStructure ElucidationSolid-State CharacterizationAnalytical Method DevelopmentSolid Oral Dosage SupportDissolution Method Development Laboratory Practices Manufacturing PracticesMethod ValidationMethod TransferMethod RemediationPharmacopeia KnowledgeICH/FDA GuidanceImpurities AnalysisTechnical TransferProject ManagementTechnical WritingRegulatory ComplianceProblem-SolvingDecision-MakingCommunicationLeadershipAttention to DetailMultitasking

Required

Bachelors degree and 7 years of Scientific experience OR

Masters degree and 5 years of Scientific experience OR

Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience

Preferred

Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization

Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.

Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase-appropriate manner

Hands-on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing

Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development.

Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations

Ability to multitask managing deliverables on complex projects against timelines

Strong leadership, problem-solving, decision-making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results

Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing document

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