Position: Scientist (CMC Analytical Development)
Location: San Francisco, CA (Onsite)
Length: 12+ months
Job Description:
Our client is seeking a dedicated Scientist to join the CMC Analytical Development group, focusing on expanding their biologics pipeline for rare diseases. This position will involve the development and execution of analytical methods to characterize both early- and late-stage biologic therapeutics. The ideal candidate will have extensive experience with physicochemical analytical techniques and will provide critical support for process and formulation development.
Essential Duties and Responsibilities (but not limited to):
- Develop and optimize analytical methods to support characterization studies for biologic therapeutics.
- Perform routine analytical testing to support process and formulation development.
- Collaborate with cross-functional teams, including Analytical Development, Quality Control, Manufacturing, and Regulatory Affairs, to ensure the timely development, validation, testing, and release of materials.
- Prepare and review protocols, technical reports, and Standard Operating Procedures (SOPs) for analytical methods.
- Assist with laboratory and manufacturing investigations and develop experiments to address technical challenges.
- Maintain lab safety standards and ensure equipment and reagents are properly maintained and stocked.
- Contribute to team collaboration by effectively communicating results, insights, and conclusions to stakeholders.
Qualifications:
- Bachelor's degree with 6-12 years of relevant experience, Master's degree with 4-8 years of relevant experience, or PhD with 2-5 years of relevant experience.
- Extensive experience with analytical techniques such as HPLC and UPLC, Capillary Electrophoresis (CE), and iCIEF.
- Proficiency in state-of-the-art analytical technologies for biologics, including HPLC (various modes and detections), CE-SDS, iCIEF, LC-MS, peptide mapping, glycan mapping, disulfide mapping, DSC, FT-IR, CD, fluorescence spectroscopy, and particle analysis.
- Strong attention to detail and a proactive, self-motivated approach to scientific problem-solving.
- Ability to analyze and interpret data and communicate findings effectively to team members and stakeholders.
- Excellent verbal and written communication skills, with the ability to work collaboratively with internal teams and external partners, including vendors and testing laboratories.
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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Job #17283