BioPharm Study Director

RJ Lee Group, Inc•Plum, PA

About The Position

About RJ Lee Group For over 40 years, RJ Lee Group has been a trusted leader in scientific consulting, laboratory testing, and materials characterization. We deliver rigorous data, clear insights, and actionable solutions to clients ranging from industry innovators to government agencies. Our mission: combine scientific expertise with innovation to solve real-world challenges. Position Summary We’re expanding our current BioPharm business line—and we’re looking for a visionary BioPharm Study Director to lead the way. This is a unique opportunity to shape a new service offering, drive technical excellence, and build strong client relationships in the biotechnology, pharmaceutical, and biomedical sectors. Your expertise and entrepreneurial mindset will help us expand capabilities, exceed client expectations, and create measurable impact. If you thrive in a dynamic environment and want to make your mark, we want to hear from you. Lead and grow BioPharm analytical services through hands-on technical work and strategic planning. Represent RJ Lee Group to existing and prospective clients; serve as a trusted technical advisor. Drive business development by attending trade shows, networking, and identifying new opportunities. Design and direct studies that meet client needs and regulatory standards. Ensure compliance with cGMP standards, 21 CFR guidelines, and other regulatory requirements. Collaborate with QA teams to maintain quality assurance and accreditation standards. Mentor and train junior staff on cGMP workflows and best practices. Manage projects end-to-end—from planning through client delivery—with precision and accountability.

Requirements

Master’s or Ph.D. in Biomaterials, Organic Chemistry, Analytical Chemistry, Biochemistry, or related field.
Minimum 2 years of experience in biopharmaceutical roles (lab, QA, or project management).
Strong knowledge of analytical techniques: FTIR, DSC, GCMS, LCMS, SEM.
Hands-on experience in cGMP-regulated environments.
Understanding of GMP quality assurance requirements and regulatory frameworks (21 CFR, FDA, ISO 17025).
Proven ability to manage projects and collaborate across teams.
Excellent communication skills for technical and non-technical audiences.

Nice To Haves

Startup mindset—flexible, resourceful, and eager to build something new.
Previous client-facing technical roles or business development experience.
Familiarity with FDA regulations and accreditation processes.
Willingness to travel and adapt to project demands.

Responsibilities

Lead and grow BioPharm analytical services through hands-on technical work and strategic planning.
Represent RJ Lee Group to existing and prospective clients; serve as a trusted technical advisor.
Drive business development by attending trade shows, networking, and identifying new opportunities.
Design and direct studies that meet client needs and regulatory standards.
Ensure compliance with cGMP standards, 21 CFR guidelines, and other regulatory requirements.
Collaborate with QA teams to maintain quality assurance and accreditation standards.
Mentor and train junior staff on cGMP workflows and best practices.
Manage projects end-to-end—from planning through client delivery—with precision and accountability.