Associate Director - Analytical Development

Location
Menlo Park, CA, United States
Posted
Apr 05, 2021
Ref
36323
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
ASSOCIATE DIRECTOR - 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.



THE ROLE

The responsibilities of this role will be to oversee and lead the department in development, qualification, and validation of analytical methods, establish specifications for testing mRNA, lipid nanoparticles (LNPs) drug product and raw materials throughout product development from preclinical stage to product approval by the regulatory agencies. In addition to methods development the incumbent will be expected to be establish systems in the department to enable stage-appropriate methods qualification, initial release and stability testing of GLP toxicology and clinical batches under GMP. Further responsibilities include creating and developing analytical strategies and collaborate with cross-functional teams including Formulation Development, Process Development, Production, Clinical Ops., Reg. Affairs and Quality in development and commercialization of gene therapy drug products.

HERE’S SOME OF WHAT YOU’LL DO

· Provide leadership in development, qualifications, and validation of a combination of analytical test methods to analyze lipid raw materials, RNAs (drug substances) and RNA/LNP (drug products)

· Establish specifications for drug substance, drug product and excipients / processing aids. Provide science-based approach to analytical methods development and validations following ICH guidance and recommendations.

· Work with mRNA process development and LNP process development teams in developing drug substances and drug products that are well characterized, stable and highest quality.

· Establish required quality systems, SOPs and standard test methods (STMs) to enable release and stability testing of materials for GLP toxicology and clinical studies.

· Prepare appropriate eCTD sections for regulatory submissions.

· Responsible for managing a department, hire, train and coach staff.

· Summarize and present data, author development reports and provide recommendations to product development teams

· Some hands-on work in the lab is expected

HERE’S WHAT YOU’LL BRING TO THE TABLE

· Minimally possess a Ph.D. in analytical or bioanalytical chemistry or a related discipline with 7+ years of directly relevant experience. Comparatively, a candidate possessing an MS in analytical or bioanalytical chemistry or a related discipline with 12+ years of directly relevant experience will be considered.

· 7+ years of analytical method development and stage appropriate methods qualification experience that include analysis of lipids and mRNA, tRNA or siRNA.

· Hands-on experience with liposomes or lipid nanoparticles or other lipid-based drug delivery systems.

· Knowledge of mass spectrometry, chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, ChemStation, Empower).

· Experience with setting specifications and stability program for parenteral drug products

· In depth knowledge of GMP and regulatory CMC.

· Highly self-motivated, driven, can-do, make it happen attitude with ability to own and drive major projects

· Strong collaborator with cross-functional teams and external partners

· Continuous learning, open-minded, curious, highly organized, thorough, relentless, diligent, detail-oriented

· Understanding of the in-vitro and in-vivo experiments and biological assays used for screening candidate formulations is a plus.

· Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules strongly preferred.

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits with a friendly, collaborative culture that values employee engagement and ongoing career development. ReCode Therapeutics is an Equal Opportunity Employer.