Position:Scientist, CMC Analytical Development
Location:San Francisco, CA (Onsite)
Length:6+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking a Scientist to join its CMC Analytical Development team supporting biologics programs focused on rare and orphan diseases. This role involves developing and executing advanced analytical methods (HPLC, CE, LC/MS), performing characterization studies, and supporting formulation and process development. The ideal candidate will have hands-on experience with biologics, strong technical knowledge, and the ability to work cross-functionally in a fast-paced, collaborative environment.
Essential Duties and Responsibilities (but not limited to):
- Develop and optimize analytical methods to support characterization of biologics-based therapeutics.
- Conduct extensive physicochemical characterization studies to support early- and late-stage development programs.
- Perform routine analytical testing to support formulation and process development activities.
- Collaborate cross-functionally with teams such as Manufacturing, Quality Control, Regulatory, and Project Development to ensure successful execution of CMC strategy.
- Author and review analytical protocols, technical reports, and Standard Operating Procedures (SOPs).
- Investigate and troubleshoot analytical or manufacturing issues as they arise; design and execute laboratory experiments as needed.
- Maintain laboratory safety and compliance in accordance with internal procedures and external regulations.
- Oversee maintenance and calibration of laboratory equipment and inventory of analytical reagents.
Qualifications:
- PhD in Analytical Chemistry, Biochemistry, or related field with 2-5 years of relevant industry experience, Master's degree with 4-8 years of experience, or Bachelor's degree with 6-12 years of experience.
- Hands-on experience with HPLC/UPLC, CE, and iCIEF instrumentation and analytical methods.
- Proficiency with advanced biologics analytical techniques such as CE-SDS, LC-MS, peptide mapping, glycan profiling, disulfide mapping, DSC, FT-IR, CD, and particle analysis.
- Strong attention to detail with the ability to interpret, summarize, and present data to technical and non-technical stakeholders.
- Excellent written and verbal communication skills; capable of working with external vendors and collaborating across departments.
- Self-motivated, adaptable, and able to thrive in a fast-paced, team-oriented environment.
- Pay range $120,000 - $130,000 depending on experience.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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