SENIOR SCIENTIST/SCIENTIST – ANALYTICAL DEVELOPMENT
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting respiratory diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: harnessing our multi-platform approach to develop disease-modifying medicines. Our team is uniquely positioned to tackle this challenge, given our extensive experience in RNA delivery technologies, protein structure, tRNA biology, mRNA manufacturing, gene editing, and drug development.
HERE’S SOME OF WHAT YOU’LL DO
- Develop, optimize, and validate analytical methods for the characterization and quality control of LNPs-mRNA process and formulation development.
- Author analytical methods, protocols, reports and develop SOPs for analytical instrument operation and analytical guidelines.
- Manage general analytical laboratory activities including maintenance of analytical equipment, qualification of new instrument as needed, organizing lab reagents and chemicals, maintaining an inventory of lab supplies and performing lab clean up on a routine basis. Also responsible for development of lab safety and compliance procedures.
- Work closely with process and formulation teams to support R&D through late phase product developments and deliver the project milestones.
- Provide technical direction to the analytical development research associates and junior scientists on experimental design, method development and troubleshooting, product characterization and data interpretation as needed.
- Coordinate method development, validation and transfer activities at CRO or CDMO and review analytical documents and testing data as appropriate.
HERE’S WHAT YOU’LL BRING TO THE TABLE
- PhD with 3+ years (or MS with 6+ years or BS with 10+) relevant industry experience preferably in an analytical development or QC environment.
- Hands-on experience with HPLC, UPLC, LC-MS and various analytical techniques is a must. Extensive hands-on experience on the analysis and characterization of mRNA and lipids is preferred.
- Track record of analytical method development, troubleshooting, optimization, validation and transfer preferably under GMP environment.
- Solid understanding of relevant regulatory guidelines and pharmacopeia as applicable to analytical method development and validation and applying the guidelines to phase appropriate analytical strategy.
- Extensive technical writing experience in authoring analytical methods, protocols, reports and SOPs.
- Attention to detail and excellent skills in Microsoft Office and data analysis software (e.g., Empower, ChemStation, Chromeleon, etc.) and other applications.
- Experience of working in a GxP environment, and CRO management for analytical method transfer is a plus.
- Must be comfortable to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
- Self-starter with excellent interpersonal skills, strong planning and tracking skills, and demonstrated success working with multi-disciplinary teams in a matrix environment.
- Strong oral and written communication skills to support internal and external communications/presentations.