Senior Associate Scientist / Scientist (Process Analytical R&D)
Cambrex is a leading global contract development and manufacturing organization (CDMO) providing drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts, Cambrex offers specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
About the role
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 in a fast-paced, dynamic environment.
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.
Requirements
- 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.
- 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.
Pay
The estimated salary range of $74,000 - $92,000 reflects an anticipated range for the Senior Associate Scientist, ARD position. The estimated salary range of $92,000 - $110,000 reflects an anticipated range for the Scientist, ARD position. The actual base salary offered may depend on qualifications, years of relevant experience, specific skills, education, certifications, and location.