Manager/Sr. Manager, Analytical Development

Scorpion Therapeutics; San Francisco (CA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in San Francisco is seeking an Analytical development scientist and QC professional to support clinical assets and regulatory submissions. The role oversees analytical development, QC, and stability activities at contract manufacturing sites, and contributes to IND/IMPD/FDA filings.

The ideal candidate has 10+ years in Analytical Development or QC in pharma, with proficiency in cGMP, ICH, USP, data analysis tools (JMP), and LIMS; strong communication skills are essential.

Qualifications

• 10+ years of experience in Analytical Development or QC in pharma.
• Proficiency in analytical techniques for biologics and small molecules.
• Strong knowledge of cGMP, ICH, USP guidelines.
• Experience with stability program management and data analysis tools.

Responsibilities

• Manage analytical development, QC, and stability activities at contract manufacturing sites.
• Author and review method transfer, validation, and stability protocols; support batch release and review of analytical data.
• Contribute to regulatory filings (IND/IMPD/BLA/NDA); lead investigations of OOS/OOT deviations; manage change controls; develop SOPs.

Tools

JMP

Veeva

TrackWise

LIMS

Job description

Role: Analytical development scientist and QC professional supporting clinical assets and regulatory submissions in biopharma.

Responsibilities

• manage analytical development, QC, and stability activities at contract manufacturing sites; author and review method transfer, validation, and stability protocols; support batch release and review of analytical data; contribute to regulatory filings (IND/IMPD/BLA/NDA); lead investigations of OOS/OOT deviations, manage change controls, and develop SOPs.

Requirements

• 10+ years of experience in Analytical Development or QC within pharma; proficiency in analytical techniques for biologics and small molecules; strong knowledge of cGMP, ICH, USP guidelines; experience with stability program management, data analysis (e.g., JMP), and enterprise QMS (Veeva, TrackWise, LIMS); effective communication skills.

Preferred

• experience with biopharma regulatory submissions and biologic modalities.

High-Value

• biologics, small molecules, stability programs, regulatory filings, contract manufacturing oversight, hybrid work with 5-15% travel.

Location: hybrid role based in San Francisco.