Sr. Manager, Analytical Development

Scorpion Therapeutics; San Francisco (CA); Hybrid; USD 175,000 - 185,000; Full time

Job summary

Scorpion Therapeutics in San Francisco, CA, seeks an experienced leader for Analytical Development and Quality Control to drive development at CRO/CMO sites and support regulatory submissions for clinical assets. The role collaborates with Drug Substance, Drug Product, and QA to ensure robust analytical strategies across development stages.

The ideal candidate has 10+ years in pharma analytics, strong cGMP knowledge, and proficiency with Veeva Vault, TrackWise, and LIMS.

Qualifications

• Excellent verbal and written communication; ability to communicate with vendors and prioritize to meet timelines.
• Ability to adapt to changing priorities and make independent decisions under tight timelines.

Responsibilities

• Manage analytical development, QC, and stability activities at contract manufacturing sites and contribute to the development of clinical assets and regulatory submissions.
• Collaborate closely with Drug Substance, Drug Product, and Quality Assurance.
• Author and review analytical method transfer and validation protocols and reports.
• Support batch release by reviewing/approving sampling plans and analytical data; generate/maintain CoAs, CoTs, and product specifications.
• Review stability protocols and monitor stability programs.
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
• Partner with QA on change controls; lead OOS/OOT and deviation investigations, identify root causes, and implement CAPAs.
• Develop, revise, and approve SOPs and QC processes.

Skills

Communication

Prioritization

Independent judgment

Cross-functional collaboration

Tools

Veeva Vault

TrackWise

LIMS

Job description

What You'll Do

• Manage analytical development, QC, and stability activities at contract manufacturing sites and contribute to the development of clinical assets and regulatory submissions.
• Collaborate closely with Drug Substance, Drug Product, and Quality Assurance.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities and timelines.
• Author and review analytical method transfer and validation protocols and reports.
• Support batch release by reviewing/approving sampling plans and analytical data; generate/maintain CoAs, CoTs, and product specifications.
• Review stability protocols and monitor stability programs.
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
• Partner with QA on change controls; lead OOS/OOT and deviation investigations, identify root causes, and implement CAPAs.
• Develop, revise, and approve SOPs and QC processes.

Qualifications

• At least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements; authoring IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries.
• Independent proficiency in analytical techniques for biologics and small molecules.
• Thorough understanding of cGMPs, USP, and ICH guidelines.
• Stability program management expertise (protocol design, data trending/analysis such as JMP, shelf-life assignment/extension).
• Proficiency with Veeva Vault, TrackWise, and LIMS.

Skills/Requirements

• Excellent verbal and written communication; ability to communicate with vendors and prioritize to meet timelines.
• Ability to adapt to changing priorities and make independent decisions under tight timelines.
• 5–15% travel; ability to travel internationally.

Where You'll Work

• Hybrid role; in-office collaboration 2x per week in San Francisco.

Compensation/Benefits (if included)

• Salary range (California): $175,000–$185,000 USD.