Scientist / Senior Scientist, Formulation Development

Forma Life Sciences•Irvine, CA

4d•Onsite

About The Position

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. 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 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. The Senior Scientist I, Formulation Development will be responsible for leading projects focused on formulation/process development of solid oral drug candidates for preclinical and human clinical studies. This role will have a major focus on the design and development of drug delivery systems and dosage forms, including use of technologies such as spray drying and Hot Melt Extrusion. This role will involve hands-on laboratory work and mentoring and training of more junior scientists. All duties will be performed in compliance with Forma’s standard operating procedures (SOPs) and GMP regulations.

Requirements

Ph.D. in chemistry or related scientific discipline with 2+ (PhD), 5+ years (MS), or 7+ years (BS) of relevant industry experience
Hands-on experience working on tablets, capsules, etc. using dilution blend, dry granulation, wet granulation and other commonly used process approaches (experience in hot-melt extrusion is required).
Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence.
Experience with supervision, mentorship, or training of other team members.
Ability to work in a well-lit heated and/or air-conditioned indoor office and laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting.

Nice To Haves

Understand the functionality and chemistry of excipients and drug substances
Able to react to change productively and handle other essential tasks as assigned
Manages personal and interpersonal stress, if required
Strong mathematic and chemistry skills
Has the discipline to stay focused and complete specific tasks
Has excellent verbal and written communication skills
Excellent organizational skills
Good troubleshooting and interpretation skills
At least 3-year direct experience in hot-melt extrusion.
Expresses ideas openly while respecting others’ viewpoints
Strictly follows the company policy on client confidentiality

Responsibilities

Develop drug formulations for innovative drug products under minimal supervision.
Performs and implements formulation strategies under minimal supervision.
Provides technical guidance internally to the formulation, analytical, and manufacturing teams on the formulation methodologies and issues.
Leads investigations of aberrant results, determination of root causes and recommends action plans.
Prepare scientific reports, experimental protocols, and batch records
Routinely acts as a project leader on formulation projects.
Represents the formulation team as a subject matter expert in client-facing situations.
Responsible for enhancing scientific and technical expertise in formulation operations.
Complies with Forma SOP and cGMP practices in documentation and equipment operation.
All other tasks and duties assigned as perceived and agreed upon by management.