Scientist, Analytical Development (Large Molecule)

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.

Requirements

• 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 in the interpretation and application of international regulatory guidelines in different phases of drug development.

Preferred Qualifications

• Improvement of any aspect of laboratory processes
• Detailed attention to data trending
• Exceptional information technology skills
• Good data interpretation skills
• Good technical writing skills
• Good problem-solving development skills
• Good attitude, work ethic, and natural leadership
• Achievement of an advanced degree

Benefits

Position Benefits

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

EOE and Accommodation

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 in connection with the recruiting process due to a disability, you may use the alternative methods by emailing [email protected]. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

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

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

EOE and Accommodation

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 in connection with the recruiting process due to a disability, you may use the alternative methods by emailing [email protected]. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

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