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Pfizer · 1 month ago

Principal Scientist, Analytical Project Lead - Peptides

United States - Connecticut - Groton

Full-time

Onsite

Senior Level, Lead/Staff

$103K/yr - $172K/yr

4+ years exp

Pfizer is a leading pharmaceutical company dedicated to delivering breakthroughs that change patients' lives. The Principal Scientist will lead analytical strategies for synthetic peptide drug substance development, ensuring quality and regulatory compliance while mentoring team members.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

Developing analytical strategies in support of synthetic peptide drug substance during all development phases, including supporting manufacturing process development, assessment of starting materials, developing, validating and transferring analytical methods, designing stability studies to understand degradation mechanisms and for shelf-life assignments, developing impurity control strategies, and authoring associated regulatory documentation

Perform lab work and will plan, direct, and review the lab work of other scientists in a matrix environment

Collaboration with internal colleagues and external partners to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate

Critically review and interpret scientific data to derive clear conclusions and provide direction for future work and will communicate results and conclusions through various media including presentations and technical reports

Evaluate new approaches, instrumentation or analytical technologies and mentor other scientists

Author relevant sections of the quality modules of regulatory submissions

Qualification

Analytical ChemistrySynthetic Peptide DevelopmentChromatographyMass SpectrometryNMRData VisualizationRegulatory SubmissionsOral CommunicationWritten CommunicationInterpersonal SkillsOrganizational SkillsProblem Solving

Required

Ph.D in Analytical Chemistry or related field, with 4+ years of R&D experience or MSc with 9+ years' of R&D experience

Demonstrated oral and written communication skills, including visualization of data, presentations and authoring technical articles

Demonstrated ability to meet timelines and interact with multi-disciplinary teams

Demonstrated ability to learn new techniques and solve complex analytical problems

Attention to detail, strong organizational skills, and effective interpersonal and communication skills are required

Proficient with a wide variety of software and information systems

Preferred

Experience with analytical aspects of synthetic peptide modalities, including hands on experience with advanced chromatographic analysis and method development along with fundamental understanding and working knowledge of various analytical techniques key to synthetic peptide drug substance development including MS, NMR, AAA, ICP-MS, GC, as well as higher order structure techniques (CD, MALS, etc.)

Understanding of impurity control strategies for synthetic peptides, including highlighting key risk factors associated with the synthetic scheme and purification processes

Knowledge and experience with formal structural elucidation of peptide related impurities

Demonstrated experience authoring and defending analytical strategies in regulatory submissions

Demonstrated breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

Sound knowledge of stage appropriate method development and related regulatory considerations