Exemplify BioPharma, Inc. a Symeres Company is a global partner research organization (PRO) based in Cranbury, New Jersey, USA. We are a team of biopharma industry experts focused on delivering end-to-end Chemistry, Manufacturing and Controls (CMC) throughout the drug development and regulatory market application processes. Using a unique combination of program management, coupled with our New Jersey based R&D laboratories and GMP manufacturing facilities we are ideally positioned to deliver CMC success to partner organizations. We are talent based team and our key asset is our experience, multidisciplinary expertise and proven track record. We strive to bring tangible value to our partners through provision of strategic, tactical and technical leadership to solve complex problems focused on reducing program timelines and costs.
The Role
Exemplify is seeking a Senior Analytical Chemist to join our dynamic analytical development team. The ideal candidate will have a strong background in analytical chemistry and 0-5 years of experience. As a Senior Analytical Chemist, you will play a lead role in developing innovative products for our clients across various industries. This is an exceptional opportunity for motivated candidates who wish to be exposed to all aspects of CMC drug development in a fast moving, collaborative and learning environment.
Responsibilities
- Lead analytical method development, optimization, and validation for small‑molecule programs.
- Work hands‑on with HPLC/UPLC, GC, LC‑MS, UV‑Vis, FTIR, KF, DSC, TGA, and related instrumentation.
- Perform impurity profiling, structural elucidation, and forced‑degradation studies.
- Interpret data and deliver high‑quality technical reports, protocols, and regulatory‑support documentation.
- Partner with formulation, process chemistry, and quality teams to support CMC strategies.
- Act as analytical lead on client projects, ensuring scientific excellence and on time delivery.
- Author and review technical documents including stability and validation protocols, specifications, test methods, Certificate of analysis/Report of analysis and other technical documents as needed.
- Complete method development, qualification and validation including release and stability methods in support of preclinical and clinical development and activities.
- Perform method trouble shooting as required and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc.
- Analysis of finished products, in-process materials, raw materials under cGMP.
- Perform stability testing on R&D and clinical batches and generate reports.
- Interface with clients.
Requirements
- A Ph.D. degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field with 0-3 years of experience in analytical chemistry.
- A demonstrated ability to conduct independent research, solve scientific problems, and work with other professionals in a highly collaborative environment.
- Demonstrated skills/expertise in analytical instrumentation including LC (HPLC, UPLC), KF titrators, dissolution, FT IR, UV-VIS, PSD, GC, LC-MS, XRPD.
- Experience in method development, trouble shooting, qualification and validation.
- Strong written and oral communication skills.
- Ability to manage multiple projects simultaneously.
- Excellent problem-solving skills and ability to work independently.
Benefits
Exemplify offers a competitive salary and total benefit package including health, dental, vision, life and short-term disability insurance through APD, including a 401K retirement saving’s plan, and paid time off.
