Job Title: Scientist Consultant (QC/AS) – Biologics Analytical Development
Location: Remote
Job Summary: We are seeking a talented professional to support analytical activities for biologic candidates moving from clinical development to commercialization. Our team values scientific expertise and the ability to communicate complex concepts to advance mission-critical biologics projects.
Responsibilities:
- Lead and execute the development, optimization, and troubleshooting of critical analytical assays, including purity, potency, and characterization.
- Support product and process characterization as well as comparability assessments for biologics candidates.
- Author and review analytical development reports and CMC documentation for regulatory submissions.
- Collaborate on analytical method qualification, validation, and transfer activities with internal and external partners.
Required:
- Bachelor’s degree in Biochemistry, Molecular Biology, or a similar scientific field and 8 years of industry experience; OR Master’s degree in Biochemistry, Molecular Biology, or a similar scientific field and 6 years of industry experience; OR Ph.D. in Biochemistry, Molecular Biology, or a similar scientific field and 4 years of industry experience.
- Expertise in microbiology assays for biologics, including bioburden, endotoxin, and sterility testing.
- Experience with common biologics analytical techniques, including method transfers and method development within CDMOs and CROs.
- Ability to oversee multiple concurrent studies at distinct laboratories, along with working knowledge of method validation principles and familiarity with US and international BLA filings and reviews.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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