Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
We are seeking a strategic and motivated Senior Scientist in analytical method development to help build and lead the analytical development function and contribute to the overall CMC strategy of drug development. The ideal candidate is expected to support analytical development of small molecule candidates (API and drug product) from Phase I through NDA for both drug substances and drug products. Inhalation experience a plus.
- Able to evaluate, design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.
- Able to conduct pre-formulation and stability studies on lead compounds.
- Collect, analyze and document results and prepare study reports.
- Communicate results of experiments with the potential to present findings to the project team.
- Manage routine laboratory operations, including safety, instrumentation, and waste.
- Prior experience with pulmonary delivery of drugs a plus.
- Able to work in a fast-paced, team-oriented environment to accelerate early drug development.
- Develop phase-appropriate quality control strategy for drug substance and drug product
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Demonstrate familiarity with QBD approach to provide analytical support to drug substance and drug product manufacture
- Author analytical development and validation reports and analytical sections in IND and NDA filings
- Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing
- Guide internal analytical development laboratory and analytical personnel to support pipeline programs
- PhD in analytical chemistry with up to five (5) years or BS/MS with a minimum five (5) years analytical development experience in the pharmaceutical industry
- Excellent scientific knowledge in analytical chemistry and organic chemistry
- Strong analytical development knowledge/experience for drug substance and drug product
- Experience with Inhalation and combination products a plus
- Prior experience with Empower a plus
- Effective verbal and written communication skills
- Experience drafting, reviewing and submitting required documentation pertaining to the cGMP environment
- Proven track record of implementing phase appropriate quality control strategies
- Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC team
- Experience managing CROs and CMOs
- Ability to navigate and be successful in a fast-paced, matrixed work environment
- Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.