Rachel Kula
Process Engineer - PhytogenX, Inc.
- Role
- Process Engineer at PhytogenX, Inc.
- Location
- West Chester, PA, US
- LinkedIn followers
- 500 followers
About Rachel Kula
Process Engineer with B.S. in Chemical Engineering from the University of Maryland. My 3+…
Experience
Process Engineer
Sep 2023 — Present · Morgantown, PA, US
Serve as a technical liaison between R&D, Quality, Compounding, and Customer Service teams to assess the feasibility of upcoming projects and support the smooth, efficient scale-up of formulations- Responsible for establishing safe manufacturing procedures for each formulation, defining critical process parameters, specifying mixing, heating, and cooling requirements, and identifying the need for specialized equipment- Conduct R&D trials to optimize scale-up processes for complex or unconventional formulations, ensuring efficient and effective transition from laboratory to production scale- Swiftly address out-of-specification in-tank batches, utilizing technical expertise to troubleshoot and implement corrective actions- Utilize root cause analysis to identify and resolve the underlying causes of out-of-specification batches, suboptimal batch yields, and inconsistent assay results- Develop manufacturing instructions for OTC drug-cosmetics and oversee validation batches to ensure successful validation of OTC procedures in accordance with FDA regulations- Maintain a strong presence on the manufacturing floor to ensure adherence to GMP standards and safety protocols, communicate and provide guidance to the compounders, monitor batch quality, and identify areas for process improvement- Document product and process changes through a change control procedure and thoroughly record process deviations and product non-conformances to ensure FDA and GMP compliance- Engage with customers to discuss manufacturing capabilities and ensure their project expectations are met
Education
University of Maryland
Bachelor's, Chemical Engineering
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.