Sr. Scientist, Injectable Formulation
Company
Our client is a well-established, U.S.-based manufacturer of sterile injectable pharmaceuticals, recognized as a longtime market leader in a specialized parenteral therapeutic category.
The company is known for deep expertise in complex parenteral formulation development and a diversified portfolio spanning generic and branded injectable products, including a leadership position in a major IV therapy category.
It continues to invest in U.S.-based manufacturing capacity, reflecting sustained growth and long-term stability for its scientific and technical teams.
The Role They Will Play
This scientist will lead formulation and process development for parenteral (injectable) drug products, from early development through commercial scale-up.
Day to day, the role designs and executes formulation studies, drives manufacturing process scale-up and technology transfer, and troubleshoots production and manufacturing issues as they arise.
What sets this position apart is its blend of hands-on bench science with regulatory-facing responsibility — supporting ANDA submissions and regulatory responses to FDA deficiencies — a combination not typical of most scientist-level formulation roles.
The role offers visibility within a formulation function that is actively growing as the company expands its U.S. manufacturing footprint, creating room for scope and responsibility to grow alongside it.
Background Profile
Our client is looking for a formulation scientist with strong parenteral development fundamentals and the regulatory fluency to support submissions and agency responses. Ideal candidates will bring:
- Expertise in parenteral (injectable) formulation development following Quality by Design (QbD) principles.
- PhD plus 5+ years’ progressive experience in pharmaceutical drug product development, or a master’s degree plus 10+ years’ progressive experience, required.
- Exposure to sterile injectable process development, scale-up, and technology transfer to manufacturing.
- Working knowledge of ANDA submission support and regulatory response to FDA deficiencies.
- Hands-on experience with analytical instrumentation such as HPLC, particle sizing, and Karl-Fischer titration is a plus.
- PhD or master’s degree in pharmaceutical sciences, chemistry, or a related field (consistent with the experience requirements above) or equivalent experience.
About KBIC Life Sciences
Kaye/Bassman’s experienced pharmaceutical and biotechnology executive search team combines managing directors, partners, and tenured consultants who have exceptional industry and functional domain knowledge.
Because we were founded on the concept of Market Mastery™, each of our recruiters works in a specific functional domain that mirrors the departments of your company. Couple that with our Client Focused Search™ approach, the result is that you get the top talent hand delivered to you fast. We work with scaling start-ups looking for cross-functional leadership. We also partner with established organizations focusing on strategic hires. All pharmaceutical, diagnostics, medical device, and related companies can benefit by partnering with Kaye/Bassman’s Pharma & Biotech team.
https://kbiclifesciences.com/
