Exemplify BioPharma, Inc. a Symeres Company, is a global partner research organization (PRO) based in 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 process development laboratories 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 Position
Exemplify BioPharma is currently seeking a Senior Formulation Scientist responsible for drug product development and clinical manufacturing of Small Molecule New Chemical Entities (NCE’s). This role will support formulation R&D, manufacturing process development, scale-up and tech-transfer from R&D to GMP manufacturing, as well as evaluate product testing data, and provide next steps for continued development. Exemplify provides complete CMC services under one roof and making this 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.
What is Required
- A PhD or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Materials Science, or a related discipline.
- A PhD with 2+ years' experience, or a master’s with 4+ years' experience in small molecule NCE formulation development and scale up in the pharmaceutical industry.
- Experience in oral dosage form (e.g., tablet, capsule, solution) development, scale up and manufacturing.
- Experience with the use of formulation processing equipment and unit operations including sifting, granulation unit operations, Wurster coating, tablet coating, compression, milling, blending, and encapsulation, etc.
- Knowledge of cGMPs, ICH guidelines, SOP’s.
- Excellent communication skills (oral, written, presentation).
- Demonstrated problem-solving skills.
- Ability to work on multiple projects in a fast-paced, dynamic, science driven environment.
Key Responsibilities of The Role
- Pre-formulation activities including compatibility studies, physiochemical characterization, assessment of manufacturing related properties such as flow measurements, compressibility and compaction studies.
- Formulation development, including design and execution of robust and scalable manufacturing processes for NCE's.
- Generation and interpretation of scientific data to support decision making.
- Preparation of product manufacturing, batch records and protocols for different product development stages, from R&D prototype formulations to process validation.
- Provision of formulation support during production of pre-clinical and clinical trial materials, scale-up and technology transfer from R&D to GMP manufacturing.
- Planning, organizing, and coordinating activities to ensure successful project progression.
- Compliance with cGMP, SOP’s, ICH guidelines and EHS policies.
- Writing and reviewing client updates and reports.