Scientist, Analytical Development; Molecule

Job Title

Scientist, Analytical Development

Analytical Development

Manager, Analytical Development

Exempt

$80,850/yr + DOE

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 Bio Duro 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.

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 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.

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.

• 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.

• A Bachelor's degree in Analytical Chemistry, Biochemistry, Cell Biology, or related field.
• 3–7 years of experience in analytical development for the pharmaceutical industry.
• Working knowledge of analytical techniques such as HPLC, GC, UV/Vis, ELISA, Activity, SEC.
• Extensive experience with the analysis of protein therapeutics and a working knowledge of small molecule analytical methods.
• Demonstrated expertise in the independent design and execution of analytical development projects.
• A working knowledge of the interpretation and application of international regulatory guidelines in different phases of drug development.

• Improvement of any aspect of laboratory processes.
• Detail‑oriented data trending skills.
• Exceptional information technology skills.
• Good data interpretation skills.
• Good technical writing skills.
• Good problem‑solving skills.
• Positive attitude, strong work ethic, and natural leadership.
• Achievement of an advanced degree.

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market‑competitive salaries to all employees. Forma also provides a variety of engaging employee and community outreach events.

We value diversity and are proud to be an Equal Opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Forma provides reasonable accommodation in job‑application procedures for qualified individuals with disabilities and disabled veterans.

If you need accommodation due to a disability, you may contact humanre

Forma is not accepting unsolicited resumes from agencies and/or search firms for this position. Resumes submitted by a third‑party agency or search firm without a valid written and signed search agreement will become the sole property of Forma. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral.