Pace Analytical Life Sciences, LLC is a premier Contract Research and Development Organization located in Woburn, MA, providing pharmaceutical development services for small molecules, biologics, oligonucleotide therapeutics, and other biopharmaceutical drug candidates.
We are currently seeking an Associate Scientist III 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. This permanent position is for Pace Analytical Life Sciences in Woburn, MA working 40 hours a week Monday through Friday.
Essential Duties and Responsibilities include the following, but not limited to:
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 (physiochemical 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 Education and/or Experience:
- Ph.D. in pharmaceutical chemistry, chemical biology, organic chemistry, biochemistry, biophysics, chemical engineering or closely related discipline. Scientist-level candidates will require at least 2 years of relevant experience.
- 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 and maintaining HPLC, LC-MS, UV-Vis, fluorescence, CD, CE, DLS and other analytical equipment/techniques.
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
OFCCP Statement – Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.