Scientist, PRD (Process Analytical R&D)

Overview:

Snapdragon Chemistry is seeking exceptional candidates for the position of Senior Associate Scientist or Scientist in our Analytical R&D group. The successful candidate will join a team of innovative and entrepreneurial scientists dedicated to providing high-quality analytical support for synthetic process development projects. We are looking for a candidate with a strong foundation in organic chemistry and analytical sciences who is passionate about working in a fast-paced, dynamic environment.

The ideal candidate will hold a BS or MS in Chemistry with 3-5+ years of experience, or a PhD with 0+ years of experience in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field within the pharmaceutical industry. The candidate should possess a strong understanding of synthetic chemistry and reaction processes, combined with broad experience in analytical method development using technologies such as (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analysis, and other techniques used to characterize pharmaceutical intermediates, APIs, impurities, and process-related materials. Knowledge of regulatory guidelines and experience in quality control testing are preferred. Candidates must possess strong written and oral communication skills and be able to work closely with process chemists to solve complex development challenges.

Responsibilities:

• Partner closely with Process Development scientists to support route scouting, reaction optimization, impurity investigations, and process understanding activities.
• Apply knowledge of organic chemistry, reaction mechanisms, and impurity formation pathways to develop analytical strategies that support process development and scale-up.
• Characterize reaction mixtures, intermediates, APIs, starting materials, and process impurities using a variety of analytical techniques.
• Develop, optimize, and qualify analytical methods for pharmaceutical intermediates, APIs, and high-value specialty chemicals.
• Utilize analytical techniques, including (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analysis, and wet chemistry assays.
• Perform moisture content testing (e.g., Karl Fischer) and other physical/chemical property determinations.
• Conduct USP and other compendial tests as required to support product release, stability, and compliance.
• Author and review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations.
• Conduct GMP testing and documentation in support of batch release, stability studies, and method transfer activities.
• Lead and execute method transfers between internal teams and external partners, ensuring technical alignment and smooth execution.
• Engage in cross-site technical interactions, including collaborative work with Cambrex sites, to align analytical strategies and ensure project continuity.
• Manage outsourced analytical testing at third-party laboratories, including project scoping, technical oversight, and data review.
• Ensure all analytical work meets cGMP standards and company quality system requirements.
• Maintain a strong sense of urgency to meet project timelines and client deliverables without compromising quality.
• Communicate directly with clients to provide project updates, interpret results, address technical inquiries, and present analytical strategies and timelines.

Qualifications / Skills::

• Strong background in analytical chemistry with a solid understanding of organic chemistry, synthetic processes, and pharmaceutical process development.
• Experience supporting process chemistry programs through analytical method development, impurity characterization, reaction monitoring, and troubleshooting.
• Demonstrated understanding of synthetic reaction pathways, degradation mechanisms, impurity profiling, and control strategies.
• Proven experience in method development, validation, troubleshooting, and transfer for pharmaceutical intermediates, APIs, and synthetic molecules.
• Broad expertise in analytical instrumentation, wet chemistry techniques, and data interpretation.
• Experience performing moisture analysis (Karl Fischer) and other USP compendial tests.
• Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations (FDA, EMA).
• Experience in quality control testing, stability programs, outsourced testing management, and cross-site collaboration preferred.
• Demonstrated ability to work with urgency while maintaining accuracy and compliance.
• Strong organizational, problem-solving, and communication skills (written and oral).
• Ability to interact confidently with clients and work effectively in a fast-paced, multi-project environment.

Qualifications:

• For the Senior Associate Scientist role, a BS or MS in chemistry or related field with 3-5+ years of experience is required. Pharmaceutical GMP experience is required. 
• For the Scientist role, a BS, MS with 5-7+ years of experience or a PhD in chemistry or related field with 0+ years of experience is required.