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Company

Original Job Post

BioSpace · 2 days ago

Scientist - Analytical Development (AD) - Late Development

Boston, MA

Full-time

Onsite

Senior Level

$108K/yr - $170K/yr

8+ years exp

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Comp. & Benefits

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Responsibilities

Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC functions and other development functions.

Contribute to complex/multiple projects or functional areas through leading or influencing others.

Influence and support initiatives related to driving scientific and technical improvement within a function and potentially cross-functionally.

Review, interpret, and communicate data cross functionally within CMC and project teams.

Coordinate with others in creating technical reports including reviewing and editing.

Conduct analysis of technical and conceptual risk and trends.

Identify process trends and define process strategy or use of novel technologies.

Recognized as a technical expert and resource within function.

Significant technical responsibility for a project area/technical program within the department and potentially across CMC.

Represent functional area on CMC project teams by communicating activities from designated functional area to project team.

Integrate scientific/technical efforts around cross-functional issues.

Identify topics for initiatives and may lead local/global initiatives as directed by senior management.

Ensure a productive and development-rich environment; Serve as a technical resource or mentor for junior staff and leverage expertise in laboratory technology as a functional resource/trainer.

Define more complex/novel approaches and methodologies to solving complex technical challenges.

Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.

Manage key vendor relationships across projects as appropriate, and affect resolution of issues arising at vendors.

Initiate and influences project direction outside department.

Prepare and review technical reports and regulatory filing documentation.

Coordinate cross-functional teams and resolutions, with a focus on scientific /technical challenges.

Qualification

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ChemistryBiologyPharmacyPharmaceutical ScienceCMC Pharmaceutical DevelopmentCGMP Manufacturing PracticesRegulatory FilingsAnalytical TechnologyProgram StrategyLate-Stage AssetsRegulatory AgenciesAnalytical TechniquesLCGCMSDissolutionParticle Size AnalysisLab SettingMethod DevelopmentMethod ValidationMethod TransferAnalytical StrategyProject CoordinationAnalytical testingLiposomeLNPFormulationsTechnical writingKnowledge management

Required

Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 8+ years relevant industry experience

Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 6+ years relevant industry experience

PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science

Experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's

Sound knowledge of current Good Manufacturing Practices (cGMP)

Experience with the use of contract facilities

Experience contributing to regulatory filings

Have developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on late-stage assets and with various regulatory agencies

Knowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, MS, dissolution, particle size analysis, etc.; Able to work in a lab setting and independently interpret results of complex experiments and integrate data produced by other disciplines

Experience with a variety of method development, validation, and transfer; Ability to design and direct analytical strategy to meet CMC project objectives

Able to coordinate resources (internal/external) to support a project

Preferred

Experience with analytical testing for liposome or LNP or other complex formulations preferred

Able to expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; has sound technical writing skills to support authorship and approval of internal technical documents.

Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors

Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use

Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferred