Senior Director, Analytical Sciences

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 crossfunctionally 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. 

Roles And 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. 

Educational 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.

Professional Job Experience Requirements

• 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.

Experience And Skills

• 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. Solutions oriented strategic thinker with strong problem-solving skills. Fosters talent development in line function.
• Regulatory Acumen: In-depth knowledge of global regulatory requirements and guidelines, ensuring all analytical strategies are compliant and future-ready. Experience supporting global regulatory submissions across the lifecycle for large & small molecules.
• 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. Experience working in an external development business model in collaboration with strategic CDMO partners.
• Exceptional Communication Skills: Ability to articulate complex concepts clearly and persuasively to diverse stakeholders, ensuring alignment and understanding across the organization.

Other Skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused
• Proven strength in logical, analytical and writing ability
• Proven ability to negotiate, influence and problem solve
• Proven ability to make sound decisions 

Travel

• Yes, 10%

Amicus Compensation And Benefit Summary

• The U.S. base salary range for this full-time position is between $250,000 and $280,000 year.  Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.  In addition to the base salary, employees may be eligible for various benefits, including health insurance, retirement plan (401K), paid time off, performance-based bonuses, stock options, restricted stock units, and other discretionary awards. Details of participation in these benefit plans will be provided during the hiring process.

We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard. Amicus is an equal opportunity employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.