Associate Director, Projects & Strategy, Analytical Sciences & Technology (AS&T)

Scorpion Therapeutics; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior analytical leader to drive the analytical development strategy for CMC Module 3. You will partner with cross-functional teams and external partners to ensure regulatory readiness for US/EU submissions.

You will lead end-to-end analytical activities, provide risk-based timelines, and manage lifecycle maintenance of analytical documents, including alignment with GMP and compendial standards. Prior ADC/biologics experience preferred.

Qualifications

• Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field.
• 10+ years’ experience in a regulated pharmaceutical environment.
• Broad experience in analytical functions (AS&T, Quality Control, or Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
• Strong late-stage analytical development and commercial support experience for antibody-based products (ideally ADCs).
• Demonstrated leadership and analytical project management experience.
• Deep understanding of US/EU regulatory frameworks (EMA, FDA), CMC analytical development documentation, GMP, and compendial standards (USP, Ph. Eur.).
• Strong organizational, communication, stakeholder management, and intercultural cross-functional skills.
• Pre-approval support experience (e.g., PLI readiness, BLA preparation, product launch) is an advantage.

Responsibilities

• Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
• Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
• Shape and align the analytical control strategy with Regulatory Affairs, CMC, and Quality to ensure compliance with regulatory expectations and health authority requirements.
• Provide leadership and oversight for analytical activities, communicating progress, timelines, risks, and challenges.
• Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.

Skills

Leadership

Communication

Stakeholder management

Intercultural collaboration

Regulatory knowledge

Analytical project management

Education

Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field

Job description

Responsibilities

• Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
• Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
• Shape and align the analytical control strategy with Regulatory Affairs, CMC, and Quality to ensure compliance with regulatory expectations and health authority requirements.
• Provide leadership and oversight for analytical activities, communicating progress, timelines, risks, and challenges.
• Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.

Qualifications

• Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; plus 10+ years’ experience in a regulated pharmaceutical environment.
• Broad experience in analytical functions (AS&T, Quality Control, or Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
• Strong late-stage analytical development and commercial support experience for antibody-based products (ideally ADCs).
• Demonstrated leadership and analytical project management experience.
• Deep understanding of US/EU regulatory frameworks (EMA, FDA), CMC analytical development documentation, GMP, and compendial standards (USP, Ph. Eur.).
• Strong organizational, communication, stakeholder management, and intercultural cross-functional skills.
• Pre-approval support experience (e.g., PLI readiness, BLA preparation, product launch) is an advantage.

Your benefits and remuneration (as stated): Expected pay range $146,300/year to $234,100/year + benefits, annual bonus & equity.