Scientist / Associate Scientist - Biopharmaceuticals
Wolfe Laboratories LLC., a subsidiary of Pace Analytical Life Sciences, is a premier Contract Research and Development Organization located in Woburn, MA.
We are currently seeking Scientists and Associate Scientists to support the rapid growth of our organization. As key members of the Pharmaceutical Development team these roles will require high-performing individuals who can design and execute studies to aid in the development of small molecules, biologics, oligonucleotide therapeutics, and other biopharmaceutical drug candidates. We are looking for individuals with a solid understanding of the analysis and/or formulation of pharmaceutical products as well a good working knowledge of the drug development process. These positions are critical in the operations of the organization and for the management of client drug development projects.
DUTIES AND RESPONSIBILITIES:
An Ideal Candidate would specialize and possess the skills to work in one or more of the following areas:
- Develop methods to characterize and understand the pharmaceutical properties (physicochemical and biopharmaceutical) of drug substances and formulations.
- In depth understanding of LC including the ability to develop HPLC and UPLC separation methodologies.
- Experience in a variety of analytical and spectroscopic techniques including UV-Vis, fluorescence, CD, CE, DLS, DSC, TGA, SEC-MALS.
- Working knowledge of LC-MS including quantitative analysis of small molecules in biorelevant fluids and biotherapeutic characterization.
- Evaluate the chemical, physical, and biophysical properties of molecules including peptides, proteins, bioconjugates relevant to biopharmaceutic drug development.
- Develop analytical and biophysical methods to characterize product variants.
- Design and perform experiments to determine the stability in prototype formulations, to detect and identify the decomposition products, and to achieve formulations with acceptable shelf-life.
- Develop and execute analytical methods for content and purity including IP-RP-LC, AEX-LC, LC-MS, CE, UV-Vis, fluorescence, etc. to characterize oligonucleotide therapeutics.
- Develop stabilizing formulations for the efficient delivery of oligonucleotide drug candidates (siRNA, RNA, DNA, etc.).
- Experience with formulation and characterization of lipid nanoparticles and other polymeric and lipid delivery systems is a plus.
- Execute and oversee specialized analytical testing and generation of technical documents
- Collect, assess and report data with a clear understanding of its reliability, interpret findings, and draw authoritative conclusions and recommendations so that their significance can be appreciated.
- Regularly interact with clients to keep them abreast of project progress
- Interface with clients to develop an in-depth understanding of client objectives and define solutions to meet their program requirements by writing persuasive proposals for projects.
- Write and review interim and final reports.
- Maintain a strong awareness of current scientific literature, particularly in the area of drug substance and drug product characterization, and actively apply new concepts as appropriate.
- Apply technical knowledge to the company improvement projects and the evaluation of new technology/processes. Collaborate with specialist scientific and/or technology teams.
- Will work as a member of cross-functional teams, with a large degree of independence representing own area of expertise.
REQUIRED BACKGROUND AND EXPERIENCE:
- Ph.D. in pharmaceutical chemistry, chemical biology, organic chemistry, biochemistry, biophysics, chemical engineering or closely related discipline.
- Understanding of drug development from the post discovery phase to the initial clinical trials phase.
- A demonstrated drive to apply technical knowledge to developing drug delivery systems and formulations.
- Established track record of significant contributions as an individual technical expert as well as the ability to thrive in a multi-disciplinary team environment.
- Outstanding written and oral communication skills as well as polished and persuasive presentation skills.
- Flexibility and outstanding time management skills to provide the full range of pharmaceutical support (including project representation) across multiple projects.
- Background using HPLC, LC-MS, UV-Vis, fluorescence, CD, CE, DLS and other analytical techniques.
Wolfe Laboratories, LLC is an Equal Employment Opportunity employer.