Job Title: Scientist, Analytical Development
Department: Analytical Development
Reporting To: Manager, Analytical Development
Classification: Exempt
Salary: $80,850/yr + DOE
What We Do
Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of the Irvine operations from BioDuro and is operating as a newly established, independent entity. As a result, Forma’s standalone online presence is still being built.
We are a lean, entrepreneurial organization of approximately 60 employees focused on drug product development and manufacturing for pharmaceutical and biotechnology clients.
Why Forma?
Unlike large, highly layered organizations, Forma operates with a hands-on, execution-driven model. Our teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results.
Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients, and contribute to building scalable systems and processes as the company grows. This is an environment well suited to individuals who value autonomy, technical excellence, and the opportunity to help shape a growing organization.
Job Overview/Summary
The Scientist, Analytical Development performs and leads analytical development activities and tasks to support formulation development and drug product manufacturing with a focus on large molecule analysis. The Scientist facilitates, plans, and manages the execution of systems to ensure cGMP compliance for all relevant operations carried out within and for Forma.
Essential Functions and Responsibilities
- Assist analytical development and characterization activities in support of our projects for biologics.
- Assist method development strategies for SDS-PAGE analysis.
- Assist in the lab to execute potency assays, ELISAs, dissolution testing, UV -spectrophotometer assays.
- Assist other routine assays in the lab not limited to HPLC analysis, water content analysis, residual solvent analysis.
- Perform in-house analytical development and protein characterization, and partner with the senior scientists.
- Work with QC, and Analytical Scientists to develop, implement and transfer appropriate analytical methods internally.
- Write and review SOPs.
- Validate methods according to ICH guideline.
- This job description is subject to change at any time.