Job Description

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

As part of our ongoing expansion, Exemplify BioPharma is currently seeking an Associate Director of Formulation Development for Small Molecule New Chemical Entities (NCE’s). This is a newly created position that will provide a unique opportunity to help build, from the ground up, Exemplify’s R&D and cGMP manufacturing capabilities.

The ideal candidate will have more than 5 years’ experience and a proven record of sustained laboratory achievement and innovation. The Senior Formulation Scientist, reporting to the Vice President of Pharmaceutical Sciences, will be responsible for supporting the build out of a new department and directing formulation development and clinical supply manufacturing activities in support of drug discovery and clinical development programs. The position requires candidates with a demonstrated track record of progressing discovery innovations through IND enabling studies and into clinical development with hands on experience in pharmaceutical research & 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 bachelor’s, master’s or Ph.D. degree in Pharmaceutics, Chemistry, or a related field.
• PhD with 2+ years' experience, or a master’s with 4+ years' experience, or bachelor’s with 5+ years' experience in small molecule NCE formulation development and scale up in the pharmaceutical industry.

· Experience with the use of formulation processing equipment and unit operations including sifting, various granulation unit operations, Wurster coating, tablet coating, compression, milling, blending, encapsulation, etc.

• Demonstrated expertise in oral dosage form (e.g., tablet, capsule, solution) development, scale up and manufacturing.
• Strong knowledge and training on cGMPs, ICH guidelines, SOP’s including audit and inspection experiences.
• Excellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills.
• Ability to work on multiple projects in a fast-paced, dynamic, science driven environment.

Key Responsibilities of The Role

• Managing formulation development, identifying efficient and scalable manufacturing processes and
• Identifying, evaluating, purchasing and installing instrumentation and equipment in support of oral (capsule, tablet, liquid) formulation development and manufacture under cGMP.
• Developing appropriate SOP’s and workflows to support cGMP clinical supply manufacture.
• Planning, organizing, and coordinating activities to ensure progress of contract projects and compliance to cGMP and SOP’s.
• Providing formulation oversight during production of pre-clinical and clinical trial materials, scale-up and technology transfer to client companies and commercial manufacturing.
• Writing and reviewing client updates and reports.

Highly Desirable

• Experience in formulation support work for Drug Discovery stage programs.
• Experience in formulation development activities in support of IND-enabling and other toxicology studies.
• Experience in solid state characterization and pre-formulation.
• Proficiency in fundamentals of drug development, including pharmacology and DMPK, and application to formulation development for small molecule New Chemical Entities (NCE’s).
• Experience in supporting business expansion with new and existing customers and leveraging network in support of business development activities.

· Knowledge of Quality by Design (QbD) and Design of Experiments (DOE).

• Entrepreneurial spirit.

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