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Principal Scientist, QC Technical Services - Pharma GMP (Remote)

Principal Scientist, QC Technical Services - Pharma GMP (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.

 

Requisition ID

170133 

Summary:
The Principal Scientist, QC Technical Services will be a key leading member of the QC Technical Services group working in a virtual quality control and technical management GMP environment and will lead technical activities in support of multiple protein-based oral commercial and clinical products.  This position will remotely manage and lead complex analytical projects at global CMOs and contract testing labs, work closely with commercial quality control and other CMC departments, and be responsible for authoring submissions and responses to regulatory agencies. 

Specific Responsibilities:

 

This position will lead key technical projects for protein-based products in commercial and clinical quality control.  Strong verbal communication and technical writing are essential; people management experience is highly desired; a demonstrated working knowledge of statistical tools (Minitab, JMP) and application of appropriate statistical approaches will ensure success in this role.
•    Lead activities focused on the development and assessment of product specifications and test methods for commercial products. Perform gap analysis of the commercial control system and develop plans for gap mitigation.
•    Develop control charts and monitor product quality and method performance.  Direct review of trends charts with commercial quality control and the CMC team. 
•    Support laboratory OOS investigations at CMO/CTLs and CAPA plans, as necessary.
•    Lead study design of protocols, data analysis, and authoring of method transfer and comparability reports 
•    Drive method lifecycle projects, including gap/risk assessments and development of mitigation plans
•    Support analytical method development and validation activities in collaboration with the Analytical Development team methods
•    Provide technical support of establishment/qualification of critical reagents, and stability studies
•    Author and review regulatory submissions and responses related to specification and analytical topics in support of new and post-approval regulatory commitments. 
•    Develop, foster and maintain positive working relationships with contract testing laboratories and manage assigned analytical activities. Coach and mentor interactions of junior colleagues with contract testing laboratories.
•    Lead, author and manage technical documents are authored with strong technical quality.
•    Work collaboratively with Commercial and Clinical Quality Control, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely completion of analytical projects supporting marketed products and product development and aligned with corporate goals.

Qualifications
•    Ph.D. degree in Biochemistry, Analytical Chemistry, Chemistry, or a related field with 
•    At least 10 years relevant experience in quality control and/or analytical development of late stage clinical and commercial small molecule and protein therapeutics in pharmaceutical setting and strong interest in analytical sciences and their applications to commercial bio/pharmaceuticals. 
•    Candidates with B.S. degree with at least 15 years of experience or M.S. with at least 12 years of experience may be considered. 

 

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 Nestlé. 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.  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. 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.

 

 

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.

 

Requisition ID

170133 

Summary:
The Principal Scientist, QC Technical Services will be a key leading member of the QC Technical Services group working in a virtual quality control and technical management GMP environment and will lead technical activities in support of multiple protein-based oral commercial and clinical products.  This position will remotely manage and lead complex analytical projects at global CMOs and contract testing labs, work closely with commercial quality control and other CMC departments, and be responsible for authoring submissions and responses to regulatory agencies. 

Specific Responsibilities:

 

This position will lead key technical projects for protein-based products in commercial and clinical quality control.  Strong verbal communication and technical writing are essential; people management experience is highly desired; a demonstrated working knowledge of statistical tools (Minitab, JMP) and application of appropriate statistical approaches will ensure success in this role.
•    Lead activities focused on the development and assessment of product specifications and test methods for commercial products. Perform gap analysis of the commercial control system and develop plans for gap mitigation.
•    Develop control charts and monitor product quality and method performance.  Direct review of trends charts with commercial quality control and the CMC team. 
•    Support laboratory OOS investigations at CMO/CTLs and CAPA plans, as necessary.
•    Lead study design of protocols, data analysis, and authoring of method transfer and comparability reports 
•    Drive method lifecycle projects, including gap/risk assessments and development of mitigation plans
•    Support analytical method development and validation activities in collaboration with the Analytical Development team methods
•    Provide technical support of establishment/qualification of critical reagents, and stability studies
•    Author and review regulatory submissions and responses related to specification and analytical topics in support of new and post-approval regulatory commitments. 
•    Develop, foster and maintain positive working relationships with contract testing laboratories and manage assigned analytical activities. Coach and mentor interactions of junior colleagues with contract testing laboratories.
•    Lead, author and manage technical documents are authored with strong technical quality.
•    Work collaboratively with Commercial and Clinical Quality Control, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely completion of analytical projects supporting marketed products and product development and aligned with corporate goals.

Qualifications
•    Ph.D. degree in Biochemistry, Analytical Chemistry, Chemistry, or a related field with 
•    At least 10 years relevant experience in quality control and/or analytical development of late stage clinical and commercial small molecule and protein therapeutics in pharmaceutical setting and strong interest in analytical sciences and their applications to commercial bio/pharmaceuticals. 
•    Candidates with B.S. degree with at least 15 years of experience or M.S. with at least 12 years of experience may be considered. 

 

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 Nestlé. 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.  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. 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.

 

Charlotte, NC, US, 28216 Raleigh, NC, US, 27615 Chicago, IL, US, 60623 S San Francisco, CA, US, 94080

Charlotte, NC, US, 28216 Raleigh, NC, US, 27615 Chicago, IL, US, 60623 S San Francisco, CA, US, 94080


Nearest Major Market: Charlotte

Apply now »