Job Description

100% Onsite Irvine CA

Pay: $30-$34/hr

Required:

• BS degree with internship/Co-op experience or AS degree with 2 years experience with HPLC/ELISA and Basic lab skills (e.g., buffer preparation)
• Basic analytical skills (e.g., pH/Osmolality/Sub-visible particle/Density and moisture content testing
• Must be highly organized and detail oriented.
• Not a requirement but preferred if the applicant has experience with any one of the following tools: RP-HPLC; SEC; CEX; qELISA; SPR.
• FDA/GMP/cGMP is preferred.

Job Description:

The incumbent in this role will support the formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use.

This position requires laboratory work in areas requiring select agents and Toxins access (i.e., Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Client internal and applicable regulatory requirements. Client internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Responsibilities

• Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.

• Supporting drug product manufacture preparation activities: buffer/solution preparation, packaging components (vials, stoppers, pumps, filters, tubing, etc.).

• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments accordingly.

• Generate high-quality data based on sound scientific understanding and prepare formulation data summaries, technical reports, and scientific presentations.

• Support functional technical initiatives by investigating and developing Client experimental approaches and/or technologies in the field of drug product development.

• Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering, shipping, and receiving.

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