Director Analytical Development - Pharma (Remote)

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature's Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

Position Summary

Aimmune Therapeutics is looking for a creative, resourceful, and integrative analytical thinker for a highly visible role that will contribute to the CMC and Quality Control (QC) aspects of the Analytical Development (AD). The Director of Analytical Development will be a strategic leader that will lead and manage analytical development activities for drug substance and drug products conducted at CTLs/CMOs in food allergy, gastro-intestinal and other therapeutic areas.

Job Responsibilities:

• Provide strategic leadership to augment the analytical development function supporting a growing clinical pipeline of products utilizing natural (plant, animal) sourced materials, recombinant proteins, synthetic molecules, and other therapeutic modalities for oral or parenteral administration.
• Establish strategic and phase appropriate analytical control strategies for all clinical programs to include method development, optimization, and validation
• Lead the Analytical Development team supporting all product testing needs as well as changes due to manufacturing process, container, or device components.
• Provide strategic directions for CMC analytical aspects of various regulatory contributions to include regulatory interactions and regulatory submissions (eg IND, BLA).
• Establish CTL network strategy supporting clinical programs.
• Provide strategic vision and implementation of appropriate analytical platforms, state-of-the art technologies, and informatic systems to meet the needs of clinical pipeline.
• Responsible for budgeting including operating, capital, and staffing costs.
• Provide leadership and ensure compliance of analytical testing activities with applicable compendia (USP, EP) and global regulatory guidance.
• Collaborate with cross-functional leaders in Quality Control, Clinical Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely completion project goals for all clinical programs and commercial product lifecycle projects.

Qualifications

• Advanced degree (M.S., Ph.D.) in Chemistry, Analytical Chemistry or related field
• 10+ yrs relevant professional experience including at least 5 yrs in a leadership role
• Demonstrated managerial experience is required including building analytical teams or functions
• Experience managing analytical services at CMOs, CTLs
• Experience with analytical method development, validation, transfer, and product characterization is required for biologics (natural, recombinant) and synthetic peptides
• Demonstrated experience with chromatographic, enzyme activity, immuno, and cell-based methods is strongly preferred
• Experience in leading completions of regulatory submissions of CMC analytical modules (IND, BLA, MAA) is required
• Comprehensive knowledge of Good Manufacturing Practices (cGMPs) and Global Regulatory Guidance Documents is required
• Travel up to 20%

Skills/Knowledge

• Creative analytical thinker; effectively manages resources to deliver high-quality results on tight timelines and within budget
• Self-starter and problem-solver with demonstrated ability to deliver results in a fast-paced development environment
• Motivates teams and, mentor and develops, staff
• Excellent written, verbal communication across functions, and with senior leadership

Skills/Knowledge

• Provide analytical strategic vision then effectively manage resources to deliver high-quality results on tight timelines and within budget
• Self-starter and problem-solver with demonstrated ability to deliver results in a fast-paced development environment
• Ability to build teams/functions and mentor, develop, and motivate staff.
• Excellent written, verbal communication with immediate team, cross-functionally, as well as with executive leadership
• Vision to recognize and implement new technologies to meet product testing requirements

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, youre at the forefront of our minds as we recruit top talent to join Nestlé. The skills youve gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestlé home.

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience.

This position is not eligible for Visa Sponsorship.