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Sr Manager Production Process Eng- Pharma (Remote US)

Company: Nestl-- Health Science
Location: Austin
Posted on: June 25, 2022

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.
Position SummaryThe Sr. Manager, Production Process Engineer will guide late-stage drug product process development, commercialization, and life cycle management activities at their contract manufacturing sites (CMOs). The incumbent will contribute to the overall success of food allergy, GI and metabolic disorder related businesses, by providing critical technical oversight to all manufacturing related initiatives. This role will provide management and oversight of CMC related activities at CMOs, focusing on process development, technology transfer, GMP facility qualifications, primary and secondary packaging, and process validations (PPQs) meeting regulatory requirements.

ESSENTIAL DUTIES:

  • Leads the life-cycle management and technology transfer activities supporting product registration, product launch and other late-stage product development activities across Aimmune portfolio products.
  • Evaluates and recommends new manufacturing and packaging technologies including in-process controls to improve current processes.
  • Leads facility commissioning and utility qualification activities meeting cGMP guidelines and applicable regulations in coordination with the CMOs and internal teams.
  • Guides process scale-up and optimization of manufacturing processes using scientific methodologies (e.g., DOE). Performs risk-based assessments to identify key process parameters affecting critical quality attributes in existing clinical stage processes.
  • Designs and executes process validation studies supporting product registration
  • Authors manufacturing-related sections of regulatory submissions (IND, BLA, NDA, MAA, IMPD)
  • Conducts manufacturing investigations related to out-of-specification (OOS) and out-of-trend (OOT) testing results and recommends [implements] appropriate CAPAs
  • Prepares and delivers development reports, protocols, batch records, and SOPs supporting regulatory requirements

    QUALIFICATIONS/REQUIREMENTS

    • BS or MS in engineering, biochemistry, or relevant discipline, with 10+ years of biopharmaceutical experience with growing responsibility in process development, technology transfer, and process validation activities.
    • Comprehensive working knowledge of cGMP requirements and FDA, USP and ICH guidelines as they relate to process development and manufacturing process validation
    • Demonstrated experience in capital project management and facility/equipment qualification
    • Hands-on experience with commercial launch preparation and product registration preferable but not required
    • Direct experience with design and optimization of processes for producing drug products
    • Experience working with CMOs in a virtual environment
    • 20% travelSpecial skills/knowledge:
      • Project management skills.
      • Proficiency in technical writing (e.g., protocols, SOPs) and good verbal communication skills
      • Excellent cross-functional team participation skills
      • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
      • Adept in computer skills with expertise in MS office programs and statistics-based tools
        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.
        Brisbane, CA, US, 94005 Albany, NY, US, 12205 Austin, TX, US, 78728 Franklin Park, IL, US, 60131

Keywords: Nestl-- Health Science, Austin , Sr Manager Production Process Eng- Pharma (Remote US), Professions , Austin, Texas

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