Gene Therapy In Vivo Bioanalytical Lead
Charlestown, Boston, MA, USA
Posted on Wednesday, February 1, 2023
Solid Biosciences is seeking an experienced and independently motivated scientist to lead our growing bioanalytical lab with an emphasis on methods development to support preclinical in vivo studies. This dynamic position will lead the design, development, and implementation of bioassays to advance the company’s preclinical gene therapy assets and support transition of these methods to the clinic. The qualified applicant will contribute to multiple projects, serve as a bioanalytical subject matter expert, contribute to study designs, lead and mentor junior team members, present data and workplans in cross functional meetings, establish and manage external bioanalytical vendor relationships. The ideal candidate will possess a strong background in preclinical in vitro and in vivo bioanalytical methods development and will be familiar with the bioanalytical regulations for preclinical and clinical drug development. The qualified applicant will be comfortable working hands-on in the lab or leading projects from the desk, as needed. We are seeking an applicant who thrives in a fast-paced, team-oriented environment. Preference will be given to applicants with experience managing bioanalytical studies conducted at 3rd party CROs.
- Lead the in-house development of bioanalytical methods to quantify AAV vector biodistribution, transgene mRNA expression, protein expression, and/or immunogenicity in a variety of biological matrices and tissues, with adherence to established program timelines.
- Serve as a bioanalytical leader and subject matter expert in cross functional teams and within the preclinical team to build internal capabilities and lead/mentor junior analysts.
- Contribute to the development of bioanalytical plans, strategy, and timelines for in vivo programs. Identify, propose, and develop new solutions to bioanalytical needs.
- Work comfortably both at the bench to develop and/or implement bioanalytical methods, and at a desk to manage projects and timelines, research new projects, manage outsourced bioanalytical projects, and contribute to cross-functional meetings.
- Identify and resolve root causes of bioanalytical method issues to minimize study impact.
- Develop and manage external CRO workstreams and the technology transfer of internally developed methods.
- Demonstrate a working knowledge of Bioanalytical Guidance for Industry documents and White Papers for endpoints associated with AAV-based therapeutic development.
- Prepare and organize data for cross-functional presentation. Communicate strategy and results in written and oral reports to various levels of management. Communicate research efforts to executive team members, collaborators, and/or at scientific meetings.
- Excellent communication and collaboration skills and ability to work with cross-functional scientists. Ability to convey ideas and opinions clearly and concisely.
- Occasional travel required for bioanalytical collaboration or vendor oversight.
Education / Experience:
- Demonstrated experience (PhD with 5+ years, or MS with 8+ years) developing and leading bioanalysis projects for vector copy number, mRNA expression via RT-qPCR, protein expression via Western blot or Jess with strong working knowledge of common laboratory instrumentation.
- Ph.D. in biology, chemistry or a related field with at least 3 years, or MS with at least 5 years, of relevant scientific and technical experience in pharma/biotech/CRO environment.
- Knowledge of preclinical drug development for AAV-based gene therapies.
- Strong knowledge and experience with application of bioanalytical assay development, qualification/validation and sample analysis as it pertains to preclinical and clinical drug development.
- Demonstrated experience with bioanalytical method documentation to support preclinical in vivo sample analysis. Experience working in a regulated (GxP) environment preferred but not required.
- Strong interpersonal skills as well as excellent communication and presentation abilities
- Ability to function in a biotech team environment by effectively collaborating within and across departments.