BioSpace · 3 days ago
Process Development Principal Scientist
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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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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
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Recent News
2024-05-31
2024-05-05
2024-04-06
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