Director, Biologics Development - REMOTE

Company: Nestl-- SA
Location: Hoboken
Posted on: March 19, 2023

Job Description:

As a leader in the science of nutrition, Nestl-- 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.Oversee Pharmaceutical API/Drug Substance Product Development, budgeting, planning and execution of API/Drug Substance and CMC strategies in a collaborative manner across internal disciplines and external partners and contractors. Accountable for all aspects related to formulation science and technology for API/Drug Substance, including specifications and CQAs, process development / chemistry and product configuration API/Drug Substance. Responsible for leading pre-clinical to phase 2/3 development, establish a development plan with strategic CMC and technical direction for the API/Drug Substance product development.This role will require a high level of collaboration across various internal functions, and Contract Manufacturing Sites; thus, the candidate must have the ability to influence, make decisions and have strong communication and leadership skills. The candidate will be expected to share his/her opinions, ask and answer challenging questions, and demonstrate collaborative attitude, all in the context of excellent science.
-Responsibilities: -

• Develop and lead recombinant biologics (enzymes) and small molecules API/Drug Substance manufacturing operations at CMO sites to advance programs in clinical development
• -Conduct gap analysis and propose innovative manufacturing process technologies and scale-up concepts to gain operational efficiencies
• -Develop product requirements in collaboration with cross-functional teams
• Serve as a subject matter expert, author and/or review technical reports and relevant sections of CMC documentation in support of regulatory submissions and amendments as well as meetings with regulatory authorities
• Responsible for resolution of deviations, investigations, and process issues through analysis of historical data and other supporting studies
• Collaborate and work with Drug Product Development, analytical development/QC and QA teams to support manufacture, lot release, and stability evaluation in compliance with cGMPs
• Identify manufacturing process changes and process data requirements needed to progress to Phase 3 clinical studies and beyond
• Other responsibilities that may be assigned from time to time to progress enzymes or other programs -
• Role of CMC Lead (API, Drug Product and Analytics) on some of the programs depending on needs
• Serve as the pharmaceutical development representative for internal and partnered project teams on API, assuring alignment of work scope to budget.
  -Requirements: -
  • BS/MS in relevant scientific or engineering discipline, PhD preferred
  • A minimum of 12 years of biopharmaceutical industry experience including managing outsourced activities
  • Experience developing biologics and small moleculesPreferred Skill Sets: -
    • Strong knowledge of GMP compliance, regulations and manufacturing operations especially as related to manufacture of biologics and small molecules
    • Experience in cell line development, upstream processing, downstream processing is a must
    • Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines with direct experience in process development, scale-up and optimization
    • Track record of consistently delivering results, having a bias for action, and translating strategy to implementation
    • Strong verbal and written communication skills, with the ability to communicate effectively with others both within and external to the organization
    • Effective decision making, demonstrating good judgment and constructive escalation
    • Proactive in consistently anticipating and proposing solutions to potential problems before they arise
    • A team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally
      -Requisition ID: -231207 -The approximate pay range for this position is $200,000 to $235,000. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position. Nestl-- offers performance-based incentives and a competitive total rewards package, which includes a 401k with Company match, healthcare coverage and a broad range of other benefits. Incentives and/or benefit packages may vary depending on the position. -Learn more at About Us - Nestl-- Careers (nestlejobs.com). It is our business imperative to remain a very inclusive workplace.To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestl--. The skills you've 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. Nestl-- seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestl-- home.The Nestl-- 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. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.This position is not eligible for Visa Sponsorship. Hoboken, NJ, US, 07030 Brisbane, CA, US, 94005

Keywords: Nestl-- SA, Hoboken , Director, Biologics Development - REMOTE, Executive , Hoboken, New Jersey