Lead Process Chemist

2 weeks ago

Cranbury, New Jersey, United States Exemplify Biopharma, Inc., a Symeres Company Full time

Senior Research Scientist – Process Development

Exemplify BioPharma, Inc., a Symeres Company, is a premier global partner research organization (PRO) dedicated to advancing the biopharmaceutical industry. Our team comprises seasoned experts focused on delivering comprehensive Chemistry, Manufacturing, and Controls (CMC) solutions throughout the drug development lifecycle and regulatory submission processes. With a unique blend of program management and state-of-the-art process development laboratories, we are strategically positioned to ensure CMC success for our partner organizations. Our greatest asset is our talent, characterized by extensive experience, multidisciplinary expertise, and a proven track record of success. We are committed to providing substantial value to our partners through strategic, tactical, and technical leadership aimed at addressing complex challenges while minimizing program timelines and costs.

Position Overview

We are currently seeking a Senior Research Scientist to enhance our Process Development Group. The ideal candidate will possess 2-5 years of relevant experience and a demonstrated history of laboratory excellence and innovation. Responsibilities include developing and refining scalable processes for new target molecules, while collaborating closely with analytical chemists, formulation scientists, contract research organizations (CROs), contract manufacturing organizations (CMOs), project managers, and regulatory specialists to ensure the successful execution of projects. The candidate should have a strong aptitude for laboratory experimentation and chemistry development suitable for kilo lab, pilot plant, or manufacturing scale-up. This role presents an exceptional opportunity for driven individuals eager to engage in all facets of CMC drug development within a dynamic, collaborative, and educational environment.

Qualifications

· A Ph.D. in Organic Chemistry with 0-5 years of experience in process development.

· In-depth knowledge of contemporary Process Chemistry, including chemo- and bio-catalysis, organometallic chemistry, and expertise in asymmetric transformations and heterocyclic chemistry.

· Proficient understanding of modern organic synthesis methods and analytical techniques, particularly HPLC, GC, MS, and NMR.

· Proven experience in process development and optimization, showcasing innovative problem-solving and creative thinking to enhance synthetic processes.

· Self-driven, capable of working independently while providing practical solutions to project challenges.

· Excellent written and verbal communication skills, with the ability to collaborate effectively within a team.

· Exceptional problem-solving and troubleshooting abilities.

· Demonstrated capacity to work collaboratively and efficiently with others.

· Adaptable and open to new ideas, thriving in a fast-paced and autonomous work environment.

Key Responsibilities

· Lead initiatives to resolve complex project-related challenges, including the design and implementation of viable new synthetic pathways and addressing specific process development issues.

· Propose, initiate, and execute enhancements in chemical routes and processes to achieve project goals.

· Maintain a high level of relevant scientific and technical knowledge.

· Effectively tackle complex synthetic challenges related to assigned projects, utilizing scientific expertise and business acumen.

· Design, execute, and influence scientific work to ensure timely achievement of project objectives, including drug substance supply, new synthetic routes, robust manufacturing processes, and supporting documentation.

· Prepare timely documentation, including technical and development reports.

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