Associate Director, CMC, Drug Substance

Scorpion Therapeutics; Boston (MA); Hybrid; USD 190,000 - 260,000; Full time

Job summary

Scorpion Therapeutics in Boston, MA seeks an Associate Director, CMC, Drug Substance to oversee development and manufacturing of small molecule APIs for clinical trials in a biopharma setting. You will manage API process development via CDMOs, lead tech transfer, and align manufacturing plans with clinical demand, while authoring regulatory CMC sections for IND/NDA/MAA submissions and supporting audits.

Travel up to 15% and remote options may apply; strong leadership and global filings

Qualifications

• PhD in Chemistry or related field with 10+ years of pharma/biotech experience.
• Proven track record managing API development at CDMOs.
• Expertise in cGMP regulations.
• Authoring regulatory sections.
• Vendor management.

Responsibilities

• Manage API process development and cGMP manufacturing campaigns via CDMOs.
• Evaluate and select vendors.
• Facilitate technology transfer.
• Collaborate with supply chain to align manufacturing plans with clinical demand.
• Author and review regulatory CMC documents for IND/NDA/MAA submissions.
• Participate in audits.
• Manage API budgets.

Skills

Vendor management

cGMP regulations

Regulatory writing

Cross-functional collaboration

Global filings experience

Education

PhD in Chemistry or related field

Job description

Role

Associate Director, CMC, Drug Substance, to oversee development and manufacturing of small molecule APIs for clinical trials in a biopharma setting.

Responsibilities

• manage API process development and cGMP manufacturing campaigns via CDMOs
• evaluate and select vendors
• facilitate technology transfer
• collaborate with supply chain to align manufacturing plans with clinical demand
• author and review regulatory CMC documents for IND/NDA/MAA submissions
• participate in audits
• manage API budgets

Requirements

• PhD in Chemistry or related field with 10+ years of pharma/biotech experience
• proven track record managing API development at CDMOs
• expertise in cGMP regulations
• authoring regulatory sections
• vendor management

Preferred

• experience with global filings
• strong communication skills
• ability to travel up to 15%
• experience in virtual manufacturing settings

HighValue

• focus on small molecule APIs
• late-stage development
• regulatory filings
• international collaboration
• API process tech transfer

WorkSetup

based in Boston, MA, with potential remote options; international travel may be required.