Scientist I - Formulation & Process Development

Scientist I (Formulation & Process Development)
$36 - $40/hr with medical benefits available at a cost
1 year initial contract with possibility of extension
100% Onsite in Irvine, CA
Standard first shift laboratory hours Monday – Friday

Orion Project Services and a market-leading pharmaceutical company have teamed up for an exciting contract opportunity for a Scientist I – Formulation & Process Development in Irvine, California.

This position offers the opportunity to support the development of innovative protein biologics, from early-stage and first-in-human programs through commercialization. You will perform hands-on laboratory studies involving biologic formulation, sterile liquids, lyophilized products and pre-filled dosage forms, while generating high-quality data that guides formulation and process-development decisions.

The ideal candidate will have a bachelor’s degree with at least three years of relevant biotechnology industry experience, or a master’s degree with at least two years of experience. Hands-on experience in biologics formulation, drug-product manufacturing, lyophilization or analytical testing is preferred. Experience working with neurotoxins, highly potent compounds or within a BSL-2 laboratory is strongly desired.

Position Overview:
The incumbent in this role will support the formulation and process 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 involves designing, executing, and reporting of laboratory experiments to advance the development of stable and effective biologic formulations. The incumbent will collaborate across multidisciplinary teams and contribute to solving technical challenges in both formulation and process optimization, to enable successful clinical and commercial progression of therapeutic biologics.

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 internal and applicable regulatory requirements. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
Main Responsibilities:

• Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
• Manufacture drug product formulation batches for evaluating formulation stability and/or for animal studies.
• Conduct clinical in-use studies to guide dose solution administration.
• Perform analytical testing and characterization of biologic samples, assessing critical quality attributes to support formulation and process decisions.
• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments
• Thoroughly document experimental procedures, results, and interpretations in laboratory notebooks and reports, ensuring compliance with company and regulatory standards.
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations
• Participate in the evaluation, implementation, and ongoing improvement of new and existing technologies, techniques, and equipment to continuously enhance formulation and process development.

Qualifications:

• BS with a minimum of 3 years or MS with a minimum of 2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry.
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Candidates must be highly organized and detail oriented.
• Hands-on laboratory experience in biologics formulation development, drug delivery, drug product manufacturing processes, lyophilization or analytical functions is preferred.
• Prior hands-on experience working with neurotoxins or highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment is strongly desired.
• Strong organizational and documentation skills; ability to maintain accurate experimental records and reports.
• Effective verbal and written communication skills with the ability to work collaboratively in cross-functional teams.

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.