Glycomine is driven to develop therapies that provide significant improvements to the quality of life for patients and families with serious rare diseases. Our team has a diverse background of drug development experience, scientific and medical expertise, and a spirit of collaboration and teamwork. This is an exciting period of growth for the company, and we are seeking passionate and talented individuals who share our mission.
About the Role
Reporting to the Vice President of Pharmaceutical Development and CMC, the Director, Analytical Chemistry will lead analytical development activities for clinical and preclinical programs by overseeing the work of contract laboratories and contributing a combination of technical expertise and collaboration skills to the drug development process. This is a unique opportunity to build the Analytical Chemistry function from the ground up while being a hands-on contributor to the success of our growing pipeline.
- Oversee the analytical development activities at contract laboratories performing GMP and R&D activities on both drug substance and drug product
- Serve as Analytical Chemistry subject matter expert supporting clinical phase and pipeline projects
- Develop and validate effective and efficient analytical methods for raw materials, in-process control, finished drug product release, and stability testing for drug substance and drug product
- Interpret technical results and convey their implications to internal and external stakeholders
- Evaluate stability studies to determine product shelf-life and set specifications
- Manage analytical data and generate relevant technical reports to support future regulatory submissions
- Key contributor to the writing and review of CMC sections in regulatory dossiers
- Represent the Analytical Chemistry function in regulatory inspections and responses
- Collaborate cross-functionally to ensure that analytical development activities are aligned with other aspects of project plans, timelines, and resources
- Manage the administrative aspects of analytical development outsourcing, including budgets, project timelines, forecasts, invoices, and contracts
- Direct or participate in compliance enhancement; required to advance company to support late-stage clinical trials and commercialization
- Direct chemical characterization studies to support the pharmaceutical development requirements
- Key stakeholder in technical transfer activities, process/product troubleshooting, and technical comparability studies
- Prefer a Ph.D. with 10+ years of relevant industry experience, or a master’s degree with 15+ years of relevant industry experience
- Experience with selecting and managing contract laboratories
- Deep expertise in analytical method development and validation for small molecules; additional biologics/proteins expertise a plus
- Experience with liposomes or lipid nanoparticles; experience with injectables a plus
- Experience implementing drug development programs (i.e., shelf life setting, impurities, etc.)
- Extensive understanding of ICH guidelines and other regulatory requirements
- Experience contributing to regulatory filings and inspections
- Skilled interpersonal communicator; able to convey complex information clearly
- Team-player who thrives in a collaborative culture
- Willingness to be a hands-on contributor in a start-up environment
- Experience with DOE and using JMP® Software for data tracking and analysis is a plus
- Experience using Microsoft Project for project management is a plus
- Previous experience with HPLC, UPLC, GC, CAD, Dynamic Light Scattering, IR, and other standards pharmaceutically relevant analytical techniques for drug product and drug substance characterization
- Position is remote with a strong preference for candidates located in Research Triangle Park, NC
- Up to 10% travel expected for vendor management
Glycomine is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(K), FSA, and much more.
To apply, please submit a cover letter and your resume to email@example.com or click the submit button below to send an email.