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Veranova · 1 day ago

Analytical Scientist - Structural Characterization

Devens, MA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $135K/yr

3+ years exp

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients for pharma and biotech customers. The Structure Characterization Analytical Scientist will utilize their expertise in structural elucidation of drug substances and impurities through various analytical methods, ensuring compliance with regulatory standards and supporting drug development efforts.

BiotechnologyHealth CareManufacturingPharmaceutical

No H1B

Responsibilities

Exercise sound technical judgment in the planning, execution, and analysis of experiments to determine structural identification of pharmaceutical actives and related substances including forced degradation for impurity enrichment, 2D NMR, high-resolution MS, HPLC and GC method development

Implement characterization approaches for the preparation, isolation, and identification of low-level impurities in a drug development environment

Author analytical test methods, protocols, reports, relevant SOPs and regulatory documents as needed

Develop and apply qNMR methods for accurate quantification of drug substances and impurities

Support method development, qualification, transfer, and validation activities for analytical procedures

Provide support for cGMP manufacturing campaigns, ensuring compliance with regulatory requirements and documentation standards

Communicate technical findings and results to both internal and external stakeholders, including clients and regulatory bodies

Collaborate with key partners including chemistry development scientists, quality control and regulatory affairs teams to ensure successful project delivery

Mentor and develop scientific staff. Ensure continued technical and professional growth of department members, encourage efforts towards excellence and knowledge sharing

Maintain and troubleshoot NMR and LCMS instrumentation (e.g., Orbitrap, Q-TOF, Triple Quad)

Qualification

Structural characterization2D NMRHigh-resolution MSAnalytical chemistryOrganic chemistryCGMP experienceCommunicationLeadership skillsProblem-solving skillsAttention to detail

Required

Ph.D. or M.S. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field. Demonstrated mastery of one or more subject areas related to structural characterization

Strong hands-on experience with 2D NMR, HR-MS

3+ years of hands-on experience in structural characterization of impurities for active pharmaceutical ingredients under cGMP's

Strong knowledge of organic structure elucidation – forced degradation, MS, NMR, etc., with the ability to train/mentor colleagues

Excellent communication, organizational, and leadership skills with ability to work independently and in a team environment

Well organized with good problem-solving skills, a high level of attention to detail and have a passion for delivering high quality data in a fast-paced environment