Scientist I - CMC formulation development for protein biologics
TR/077976
Posted: 10/06/2025
- $36 - $39 per hour, Benefits: individual medical benefits available at a cost
- United States, California, Irvine
- Contract
Scientist I - CMC formulation development for protein biologics
Length of Contract: 12 months
Location/Site: Irvine, CA - 100% onsite
Hourly Pay Rate: $36-39/hr (individual medical benefits available at a cost)
Position 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 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.
Responsibilities
Qualifications:
What are the top skills, experience or education required for this position:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Length of Contract: 12 months
Location/Site: Irvine, CA - 100% onsite
Hourly Pay Rate: $36-39/hr (individual medical benefits available at a cost)
Position 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 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.
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 to support animal studies.
- Conduct clinical in-use studies to guide dose solution administration.
- 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 novel 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.
Qualifications:
- BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry
- CMC development experience in protein formulation, drug delivery, or analytical functions is preferred.
- Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail-oriented.
- Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher) are good to have.
- Prior experience with drug product manufacture processes and lyophilization are desirable.
- Excellent communication skills are required.
What are the top skills, experience or education required for this position:
- Candidates must exhibit technical ability to execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
- Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g HPLC, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher)
- Candidate must be able to interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments accordingly.
- Candidates are required to generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations.
- BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry. CMC development experience in protein formulation, drug delivery, or analytical functions is preferred.
- Prior experience with drug product manufacture processes and lyophilization is desirable.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Rachael Jalbuena
Recruitment Consultant
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