Senior Director, Analytical Sciences

Amicus Therapeutics • Princeton, NJ

114d • $250,000 - $280,000

About The Position

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases. The Sr. Director of Analytical Sciences will spearhead CMC analytical method development and validation, characterization testing for both clinical and commercial programs, with a strong focus on large molecule analytical development and lifecycle management. This pivotal role demands expertise in large molecule analytical development and validation, strategic leadership, and exceptional communication skills to ensure our analytical strategies are robust and compliant with regulatory standards, ultimately meeting our patients' needs. The successful candidate will collaborate cross-functionally with Tech Ops, Quality, and CMC Regulatory Affairs to drive timely program execution, regulatory responses, and change management initiatives. They will oversee outsourced analytical packages, ensuring scientific rigor and regulatory compliance, while prioritizing patient impact, particularly in the realm of large molecule therapies. This role involves close partnership with the QC organization to implement continuous improvement initiatives and timely project progression. This leader will provide strategic oversight of analytical content for regulatory submissions, champion innovation in analytical sciences, and ensure our organization remains at the forefront of CMC analytics. The role includes managing and developing a team of 3–5 members, supporting lifecycle activities across the portfolio, and representing Analytical Sciences at the CMC Leadership Team.

Requirements

• Advanced Degree in Analytical Chemistry or Related: A Ph.D. is preferred, demonstrating a high level of expertise in large molecules or an M.S. with 15+ years experience in large molecules with an understanding of small molecule analytics.
• Extensive Experience: Over 10 years of hands-on experience in large molecule analytical development and validation, showcasing a deep understanding of the complexities involved. Experience with or understanding small molecule analytics a plus.

Nice To Haves

• Leadership Excellence with a Performance Driven Approach: Proven track record of strategic leadership in a fast-paced environment, with the ability to inspire and guide a team towards achieving ambitious goals.
• Regulatory Acumen: In-depth knowledge of global regulatory requirements and guidelines, ensuring all analytical strategies are compliant and future-ready.
• Innovative Mindset: A forward-thinking approach to analytical sciences, constantly seeking new ways to enhance processes and drive innovation.
• Collaborative Spirit: Strong ability to work cross-functionally with Tech Ops, Quality, and CMC Regulatory Affairs, fostering a collaborative and productive work environment.
• Exceptional Communication Skills: Ability to articulate complex concepts clearly and persuasively to diverse stakeholders, ensuring alignment and understanding across the organization.

Responsibilities

• Drive Analytical Strategies: Lead the development and execution of analytical strategies, ensuring timely and robust delivery of operational goals.
• Foster Strong Partnerships: Build and nurture strong relationships with Quality Control leadership, evolving both analytical and quality organizations and their ways of working.
• Ensure Quality and Compliance: Oversee CMC analytical development & characterization activities for both large and small molecules, ensuring they meet quality standards and align with global regulatory expectations.
• Provide Expertise: Offer subject matter expertise for large molecules, supporting ongoing analytical projects, investigations, and regulatory information requests and submissions.
• Collaborate Cross-Functionally: Liaise with Global Regulatory Affairs, Technical Operations, Science, and Quality partners to achieve program objectives and provide opportunities for personal and talent development.
• Engage with Industry: Participate in external industry trade organizations and consortia to benchmark best practices and drive innovation within Amicus.
• Lead and Develop Teams: Provide strategic leadership to the team, ensuring the personal development of direct reports and fostering a high-performing, accountable culture.
• Communicate Effectively: Ensure clear and concise communication with cross-functional teams and manage senior stakeholder engagement.
• Partner with CDMOs: Collaborate with CDMO organizations to support analytical development, validation, and innovative analytical strategies.
• Report to Leadership: Report to the VP, CMC, and be an integral part of the CMC Leadership Team.

Benefits

• Health insurance
• Retirement plan (401K)
• Paid time off
• Performance-based bonuses
• Stock options
• Restricted stock units
• Other discretionary awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees