Scientist II, Analytical Development
About The Position
Responsible for analytical development activities for small molecule drug substances from preclinical through commercial phases. This laboratory-focused role requires deep expertise in analytical chemistry and strong problem-solving skills. With supervision, the Scientist II independently supports analytical method development, execution, validation, transfer, and troubleshooting for control of raw materials, in-process materials, intermediates, and final products. The role also helps oversee analytical work performed at external CROs and CDMOs and conducts work in compliance with cGMP, safety, and regulatory requirements. The position works cross-functionally with CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions. It contributes to control strategy development and scientific and technical alignment through all phases of product development.
Requirements
- Bachelor's degree in chemistry or a closely related field and 4 years of pharmaceutical-industry experience focused on analytical chemistry; alternatively, a master's degree in chemistry or a closely related field and 2 years of similar experience; or a Ph.D. or equivalent in chemistry or a closely related field and some relevant experience, which may include postdoctoral experience.
- Extensive hands-on experience in pharmaceutical analysis and method development and validation for various active ingredients and/or dosage forms.
- Solid understanding of project and group goals and methods, and ability to explain the process behind data and the implications of results.
- Strong knowledge of one or more scientific disciplines, with developing expertise in one discipline, and strong knowledge of scientific principles, methods, and techniques.
- Strong knowledge of and demonstrated ability to work with a variety of laboratory equipment and tools.
- Ability to work as part of a team and train junior staff; ability to lead teams.
- Excellent computer skills.
- Strong communication, problem-solving, and analytical-thinking skills.
- Detail oriented while able to see the broader scientific impact on the team.
- Ability to meet multiple deadlines with a high degree of accuracy and efficiency.
- Strong project-management skills.
- Effective report-writing and oral-presentation skills; excellent written and verbal communication skills.
- Ability to build effective working relationships and maintain confidentiality regarding company intellectual property and proprietary endeavors.
- Ability to creatively solve complex problems in a team environment.
- Cross-functional understanding related to drug development.
- Working knowledge of regulatory requirements for drug product commercialization, NDA preparation, and cGMP, including quality assurance and quality control practices and issues.
- Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD.
Responsibilities
- Support research and development, technology transfer, and commercialization of drug substance and drug product processes, including oversight of batch testing and release and contributions to regulatory documents.
- Provide analytical project management for Chemical and Product Development projects.
- Analyze and evaluate materials and products at all stages of development.
- Monitor and evaluate the completion of tasks and projects.
- Plan and manage projects.
- Represent Analytical Chemistry on cross-functional teams.
- Maintain accountability for analytical deliverables and progress on R&D and manufacturing plans for development projects.
- Independently design, plan, and execute activities for one or more analytical chemistry projects supporting preclinical through commercial activities.
- Supervise laboratory work and/or laboratory personnel and ensure safe laboratory practices.
- Perform analytical development and optimize methods in support of preclinical through commercialization.
- Create and implement novel ideas and techniques to support analytical activities with Chemical and Product Development.
- Support off-site analytical transfers, manufacturing, and interactions with contractors.
- Contribute to CMC regulatory documentation and supporting work.
- Guide laboratory personnel and support their professional development.
- Contribute to the development of policies and department strategies.
- Build and enhance internal and external professional relationships.
- See projects through to completion and use negotiation, persuasion, and influence effectively.
- Perform other duties as assigned.
Benefits
- Retirement savings plan with company match
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental, and vision coverage
- Annual bonus with a target of 20% of earned base salary
- Eligibility to participate in the equity-based long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
