Head of Analytical Development & Quality Control

Scorpion Therapeutics; United States; Remote; USD 218,000 - 300,000; Full time

Job summary

A leading biopharmaceutical company is seeking a CMC leader to manage their Analytical Development & Quality Control organization. The role involves overseeing analytical development for drug substances and products, ensuring regulatory compliance, and leading a team of professionals in a dynamic environment. The ideal candidate will possess extensive experience in CMC development, strategic thinking, and strong leadership skills.

Benefits

Competitive salary and bonuses

Comprehensive health and retirement benefits

Generous parental leave and family benefits

Culture focused on growth and development

Qualifications

• 13+ years experience with PhD or 18+ years with MS in CMC development.
• Proven success in leading analytical development in outsourced environments.
• Experience with regulatory submissions, especially Module 3 CTD content.

Responsibilities

• Lead Analytical Development & Quality Control for global product commercialization.
• Manage scope, milestones, budgets, and timelines for analytical activities.
• Collaborate with supply chain and regulatory agencies.

Skills

Leadership

Communication

Collaboration

Decision-making

Vendor Management

Education

PhD in Chemistry

MS in Chemistry

Job description

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Job Description

We are seeking a results-oriented, innovative, broadly experienced, CMC leader who will lead and manage Deciphera’s Analytical Development & Quality Control organization. The incumbent will build and develop a team with expertise in method development and QC to support GMP manufacture and commercialization of small molecule, ASO, and biologic drug substances, covering a range of dosage forms from oral solids to injectables and topicals. Operating within a largely outsourced model, the successful candidate will oversee all analytical development and QC activities related to Deciphera’s clinical and commercial portfolios, from discovery through registration and commercialization, including potential in-licensing evaluations. Responsibilities include analytical characterization, method development, qualification, transfer, and validation for QC release and stability testing of various drug substances, products, intermediates, and materials.

The role requires strategic thinking, a global vision, and a focus on quality, reliability, consistency, regulatory compliance, capacity, cost efficiency, and operational performance. The candidate must be highly organized, detail-oriented, decisive, and capable of strategic and operational thinking. Extensive experience in CMC development and commercialization of small and large molecules, along with understanding of regulatory landscapes in the US, EU, and Japan, is essential. The role involves leading a team of analytical and QC professionals and participating as a key member of the Pharmaceutical Development Leadership Team.

What You’ll Do

• Lead and manage Analytical Development & Quality Control to support successful development, registration, and commercialization of products globally, including partnerships and licensing.
• Set and implement the enterprise-wide vision and strategy for the analytical organization to enable global product development and commercialization.
• Align strategies and deliverables across functions and ensure integration with overall program goals.
• Manage scope, milestones, budgets, and timelines for analytical activities.
• Select and monitor CROs and CDMOs based on capabilities, capacity, and compliance, establishing KPIs for performance.
• Oversee characterization activities and development, validation, and implementation of analytical methods for various drug substances and products.
• Collaborate with supply chain, development, engineering, manufacturing, QA, and other disciplines to ensure continuous supply.
• Manage stability operations, reference standards, and technical documentation including GMP documents and regulatory submissions.
• Negotiate and operationalize agreements with external partners.
• Support licensing opportunities and external collaborations.
• Guide regulatory CMC strategies and review regulatory submissions and responses.
• Ensure successful transfer and implementation of analytical methods across sites.
• Maintain relationships with CRO and CDMO partners and support governance meetings.
• Monitor external environment, identify risks, and develop mitigation strategies.
• Represent the organization in meetings with regulatory agencies like FDA and EMA.

Qualifications

Required Qualifications:

• PhD in Chemistry or related field with 13+ years of experience OR MS with 18+ years of experience in small and large molecule CMC development.
• Proven success leading analytical development and QC programs in an outsourced environment.
• Strong vendor management, communication, and collaboration skills.
• Experience in planning and executing CMC projects.
• Decision-making and stakeholder influence skills.
• Deep knowledge of drug development, ICH guidelines, and regulatory processes.
• Experience with regulatory submissions, especially Module 3 CTD content.
• Ability to communicate complex issues clearly across diverse audiences.
• Leadership skills to motivate and influence teams and stakeholders.
• Understanding of industry standards and trends.
• High integrity, reliability, and ability to travel (~10%).

Preferred Qualifications

• Experience in oncology drug development and commercialization.
• Background in protein therapeutics or ASOs.
• PhD in engineering or life sciences, or an MBA in operations is a plus.

Additional Information

Salary range: $218,000 - $300,000, depending on experience and location. Deciphera offers competitive benefits, including bonuses, health coverage, 401(k), parental leave, and growth opportunities.

Benefits

• Competitive salary and bonuses.
• Comprehensive health and retirement benefits.
• Generous parental leave and family benefits.
• Culture focused on growth and development.

Apply Now

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EEO Statement

Deciphera is committed to diversity and equal opportunity. Completing our confidential survey is optional and will not affect your application. We value diversity and are an equal opportunity employer.