Sr. Scientist/Principal Scientist/Sr. Principal Scientist, Analytical Development
Boulder, Colorado /
Technology Operations – CMC /
Full-Time
/ On-site
Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team
Responsibilities
- This is a laboratory role where the successful candidate will provide technical expertise to analyze, characterize, and purify compounds to support preclinical/research to late-stage CMC laboratory activities to progress small-molecule products in the pipeline.
- Apply phase-appropriate drug development to support the analytical aspects of drug substance and drug product.
- Provide technical support in resolving manufacturing and/or analytical testing issues, which may involve designing and executing experiments to understand root cause.
- Responsible for the routine maintenance and qualification of analytical instrumentation as well as the procurement of new instrumentation and training of colleagues.
- Prepare standards, mobile phases, and reagents.
- Prepare, review and/or approve technical documents (methods, specifications, protocols, reports).
- Manage and review data packages for release and stability of drug substances, intermediates and drug products generated by contract manufacturing organizations.
- Support the preparation of CMC sections of regulatory submissions along with other functional groups.
- Participate in analytical investigations for deviations/OOS/OOT and ensure proper corrective actions are taken.
Qualifications
- Bachelor’s degree in Chemistry, Pharmaceutical Chemistry or related discipline with 10+ years’ experience OR
- Master’s degree in Chemistry, Pharmaceutical Chemistry, or related discipline with 7+ years’ experience OR
- PhD in Chemistry, Pharmaceutical Chemistry, or related discipline with 5+ years’ experience.
- Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, as well as ability to work independently are essential.
- Experience in a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, spectroscopic techniques (e.g., FT-IR, XRPD, etc.), HPLC /UPLC & GC with a variety of detection methods, dissolution, wet chemical analysis (e.g., KF, pH, etc.), particle size, heavy metal analysis, NMR, and interpretation of data.
- Expertise in one or more analytical techniques.
- Experienced in method development, qualification, validation and technology transfer and oversight of activities at contract development and manufacturing organizations.
- Autonomous accomplishment of analysis in the laboratory.
- Good understanding of the drug development process, knowledge of GMP and applicable FDA, EMA and ICH guidance documents and familiarity with the USP and other compendia are expected.
- Strong technical writer, reviewer, and communicator.
- Able to express oneself clearly and concisely within team.
- Exercise good time management and prioritization skills and can successfully manage multiple tasks simultaneously.
- Approximately 75% of the time will be in the laboratory supporting R&D activities.
- Self-motivated, organized, reliable, and safety-minded.
- Requires expertise and proficiency with lab equipment (HPLC, LC/MS and/or GC) and data collection/processing/interpretation.
- May be required to lift, up to 25 pounds without assistance.
- Approximately 5% travel may be required.
Required Abilities
Compensation
- Salary: $115,000 - $155,000
- Target Bonus: 12.5 - 15&
Exact compensation may vary based on skills, experience, and location.
