Senior Scientist I, Analytical Chemistry

The Role

Transform Lives Through Scientific Innovation
Join a growing pharmaceutical CDMO where your expertise will directly support the development of innovative drug products that improve patient health worldwide.

Responsibilities

• Lead the development, optimization, and validation of robust analytical methods for drug substances and drug products in accordance with ICH, USP, and regulatory guidelines.
• Design and execute complex analytical studies to support formulation development, process development, stability programs, and customer projects.
• Lead or support technology transfer of analytical methods to internal and external QC laboratories and CMOs.
• Implement new analytical techniques and instrumentation to expand internal capabilities.
• Act as a subject matter expert (SME) for analytical technologies, method troubleshooting, and regulatory inspections.

Scientific Leadership & Technical Execution

• Provide leadership and execution of complex scientific experiments.
• Utilize creative thinking to generate solutions to complex technical problems.
• Prioritize personal workload to ensure key objectives are achieved on time and within project expectations.
• Stay current with advancements in analytical technologies, industry best practices, and regulatory expectations.
• Mentor and provide technical oversight to junior scientists and analysts, ensuring scientific rigor and compliance with quality standards.

Documentation, Compliance & Regulatory Support

• Author and review technical documents, including method validation protocols and reports, specifications, analytical development reports, and regulatory submissions (IND, NDA, ANDA, BLA).
• Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
• Ensure compliance with GMP requirements, regulatory expectations, and internal quality systems.
• Support regulatory inspections, customer audits, and compliance initiatives as required.

Cross-Functional Collaboration & Business Support

• Collaborate cross-functionally with Formulation Development, Process Development, Quality Assurance, Regulatory Affairs, Manufacturing, and customer teams to ensure successful product development.
• Represent Analytical Chemistry in project meetings and customer meetings with limited supervision.
• Contribute to continuous improvement initiatives and innovation within the analytical development function.
• Support Marketing and Business Development activities through technical presentations, posters, publications, blogs, white papers, and industry conferences.
• Support cross-functional training and execution of activities within the R&D Product Development & Design Team as needed.

Qualifications

• PhD in a scientific discipline with 1+ years of relevant experience; Master's degree with 3+ years of experience; Bachelor's degree with 6+ years of experience; or 9+ years of equivalent experience without a degree.
• In-depth experience with analytical techniques including HPLC, UPLC, GC, UV, FTIR, spray testing, compendial methods, and related analytical technologies.
• Demonstrated success in analytical method development, optimization, validation, and troubleshooting under GMP and ICH guidelines.
• Strong understanding of regulatory requirements and CMC components of pharmaceutical drug development.
• Experience with stability testing, impurity/degradant characterization, and forced degradation studies.
• Proven ability to lead technical projects and work effectively within cross-functional teams.
• Strong written and verbal communication skills, including experience authoring technical and regulatory documentation.
• Demonstrated ability to mentor, influence, and develop junior scientists and technical staff.
• Experience with nasal spray drug products and device-related analytical testing is preferred.
• Experience within pharmaceutical, biotechnology, contract development and manufacturing (CDMO), or regulated product development environments strongly preferred.

Physical Demands / Qualifications

• Employee is required to regularly use hands in order to handle laboratory materials and supplies.
• Employee is required to use computers for extended periods each day.
• Employee is required to effectively communicate through both verbal and electronic means.
• Employee is required to regularly stand and walk for extended periods of time.
• Employee must occasionally lift and/or move up to 25 pounds.
• Able to use proper lifting techniques and remain aware of laboratory and workplace hazards.
• Employee is required to follow all site safety procedures and wear appropriate PPE.