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Scientist (I, II, III) - CMC - PR/541864_1744754240

Scientist (I, II, III) - CMC

San Diego
Permanent
USD120000 - USD170000
Research And Development
PR/541864_1744754240
Scientist (I, II, III) - CMC

Our Client

Our client is a San Diego-based biopharma company developing cutting-edge monoclonal antibodies and antibody-drug conjugates for cancer and inflammatory diseases. Known for its innovative immuno-oncology approach and rapid growth through strategic acquisitions, it's been recognized as a top biotech startup and awarded Biopharmaceutical Company of the Year in California. If you're looking to bet on the future of cancer treatment, this is a fun one to watch.

Job Title: Scientist I / II / III - CMC

Location: San Diego, CA
Department: CMC / Biologics Development
Reports To: Director, CMC

Position Summary

Seeking motivated and detail-oriented Scientist I, II, and III candidates to support CMC activities for our pipeline of biologic therapeutics. The ideal candidate will contribute to the development, characterization, and manufacturing of monoclonal antibodies and ADCs from preclinical through clinical phases. Title will be commensurate with experience.

Key Responsibilities

Scientist I - Entry-Level

  • Assist in development of upstream and/or downstream processes for mAbs and ADCs

  • Support tech transfer, batch records, and documentation preparation

  • Conduct routine analytical testing (e.g., SDS-PAGE, SEC, ELISA)

  • Collaborate with external CDMOs to support CMC activities

  • Maintain accurate records in lab notebooks and internal systems

Scientist II - Mid-Level

  • Design and execute process development studies with minimal supervision

  • Lead specific workstreams within CMC projects

  • Analyze data, troubleshoot experiments, and present findings cross-functionally

  • Contribute to IND/IMPD filings by authoring and reviewing CMC sections

  • Oversee assay development and product characterization efforts

Scientist III - Senior-Level

  • Drive CMC strategy across multiple projects from early to late-stage development

  • Serve as technical lead for external partnerships and CDMOs

  • Guide junior staff and ensure scientific rigor in process development

  • Own and manage timelines, budgets, and quality for CMC deliverables

  • Represent CMC function in cross-functional meetings and regulatory discussions

Qualifications

Scientist I

  • BS/MS in Biochemistry, Chemical Engineering, or related field with 0-2 years of industry experience

  • Hands-on lab experience with biologics or protein purification preferred

Scientist II

  • MS/PhD in Biochemistry, Chemical Engineering, or related field with 3-6 years of industry experience

  • Proven track record in process development and analytical techniques

Scientist III

  • PhD with 5-8 years or MS with 8+ years of industry experience in biologics development

  • Deep expertise in CMC strategy, regulatory submissions, and manufacturing operations

  • Experience in leading tech transfers and managing CDMO collaborations


FAQs

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