Your Role:
The Associate Scientist, Biologics Formulation Development will lead formulation development activities within the Process Development department. This role is responsible for defining formulation strategies, executing technical studies, and supporting cross-functional integration as the capability expands. The individual will collaborate closely with Downstream Process Development, Analytical Sciences, Program Management, and external partners to support client programs.

Key Responsibilities:

• Lead formulation development of biologics (mAbs), including pre-formulation assessments, excipient screening, and stability studies.
• Hands-on experience with analytical techniques for protein characterization, including DLS, DSF, SEC, CE, rheology, and spectroscopy.
• Expertise in developing high concentration mAb formulations and resolving issues such as aggregation, viscosity, and solubility. Ablity to identify and mitigate formulation risks including precipitation and chemical degradation.
• Design experiments, analyze data, and prepare technical protocols, reports, and development summaries.
• Design and interpret analytical testing strategies including HPLC (SEC & IEX), CE-SDS, SDS-PAGE, UV spectroscopy, and other biophysical assays to support formulation studies.
• Establish scientific strategy, workflows, and best practices for biologics formulation development.
• Proven ability to work independently in dynamic, fast-paced environments with evolving priorities.
• Present scientific study plans, results and observations to internal and external stakeholders
• Mentor junior scientists/staff and support onboarding of new team members.
• Ensure compliance with relevant quality and safety standards.
• Perform other duties as assigned

Minimum Qualifications:

• Master's degree/PhD degree in Biochemistry, Chemistry, or related field and minimum 4-5 years of relevant experience and demonstrated working knowledge of scientific principles.
• Prior experience in formulation development, stability studies, and analytical characterization of biologics or strong background in biochemical and biophysical characterization of proteins with deep understanding of protein structure and function.
• Hands-on experience with biophysical and analytical techniques such as DSC, DLS, DSF, CD, HPLC, CE-SDS, UV spectroscopy, etc.
• Proven record of strong technical writing and communication skills.
• Ability to thrive in a dynamic, cross-functional environment.

Preferred Qualifications:

• Ph.D. in Biochemistry, Chemistry, or related field with 1-2 years of industry experience, or M.S. with 4-5 years of experience.
• Prior experience in downstream process development of biologics is a plus.
• Experience mentoring or leading scientific staff preferred.

Position Type/Expected Hours of Work:

This role is a full-time onsite position in Costa Mesa, CA. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $94,400 - $118,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.