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Principal Scientist, QC Technical Services - Pharma (Remote)

Principal Scientist, QC Technical Services - 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.

 

Requisition ID

170133 

Position Summary

The Principal Scientist, QC Technical Services will be a key member of the QC Technical Services group working in a virtual quality control and technical management environment and will lead technical activities associated with quality control of commercial products.  This position will remotely manage analytical activities at global testing facilities, 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 provide key technical support in all areas of commercial quality control activities,
• Lead activities focused on the development and assessment of specifications attributes and acceptance criteria.
• Lead development of control charts and monitor product quality and method performance.  Review these charts for trends and take action as necessary.
• Develop protocols and prepare reports for method transfers and comparability studies
• Lead method lifecycle projects and validate methods.
• Support investigations, critical reagents, and stability studies by providing technical insight.
• Author regulatory submissions and responses related to specification and analytical topics.
• Develop working relationships with contract testing laboratories and manage assigned analytical activities. 
• Author SOPs
• 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 commercial products and aligned with corporate goals.
 

Qualifications
• B.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• 12+ years of relevant experience in quality control and/or analytical development in pharmaceutical setting or M.S. with at least 10 years of experience or a PhD with at least 8 years of experience relevant to the responsibilities of this position and strong interest in analytical sciences and their applications to commercial bio/pharmaceuticals.

 

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 

Position Summary

The Principal Scientist, QC Technical Services will be a key member of the QC Technical Services group working in a virtual quality control and technical management environment and will lead technical activities associated with quality control of commercial products.  This position will remotely manage analytical activities at global testing facilities, 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 provide key technical support in all areas of commercial quality control activities,
• Lead activities focused on the development and assessment of specifications attributes and acceptance criteria.
• Lead development of control charts and monitor product quality and method performance.  Review these charts for trends and take action as necessary.
• Develop protocols and prepare reports for method transfers and comparability studies
• Lead method lifecycle projects and validate methods.
• Support investigations, critical reagents, and stability studies by providing technical insight.
• Author regulatory submissions and responses related to specification and analytical topics.
• Develop working relationships with contract testing laboratories and manage assigned analytical activities. 
• Author SOPs
• 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 commercial products and aligned with corporate goals.
 

Qualifications
• B.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• 12+ years of relevant experience in quality control and/or analytical development in pharmaceutical setting or M.S. with at least 10 years of experience or a PhD with at least 8 years of experience relevant to the responsibilities of this position and strong interest in analytical sciences and their applications to commercial bio/pharmaceuticals.

 

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.

 

Brisbane, CA, US, 94005 Eden Prairie, MN, US, 55344 Dunkirk, NY, US, 14048 Eden, NC, US, 27288 Bridgewater, NJ, US, 08807

Brisbane, CA, US, 94005 Eden Prairie, MN, US, 55344 Dunkirk, NY, US, 14048 Eden, NC, US, 27288 Bridgewater, NJ, US, 08807


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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