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Director Product QA/QC - Pharma (Remote)

Director Product QA/QC - 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.

 

 

198396 

 

Summary

The Director Quality Control Stability Program Management will be a strategic leader of the Stability Function and he/she will provide strategic direction, lead, implement, and manage all activities associated with stability Aimmune’s commercial and clinical drug substance and drug products conducted at CTLs/CMOs in food allergy, gastro-intestinal and other therapeutic areas.  The candidate will provide strategic leadership and planning for further development of the stability function to support a robust, challenging, and growing pipeline of clinical programs for products utilizing natural (plant, animal) sourced actives, recombinant proteins, and other therapeutic modalities in different presentations (oral (capsules, sachets), parenteral (liquid) and devices).  While managing a team, the candidate will be responsible for establishing strategic and regulatory appropriate stability strategies for clinical programs from early stage through late stage and commercial products (registrations, post-approval studies).  The individual will also manage all aspects of new and on-going stability programs protocols, reports and data entry into LIMS, data trending using statistical software, shelf-life establishment/update, as well as, investigation into stability quality events.  In addition, the candidate will be responsible for regulatory submissions (stability request for information, stability modules of IND, BLA and MAA), manage implementation/update of SOPs.  Prior experience with commercial and clinical quality control release/stability testing/manufacturing development of pharmaceutical products is required. The candidate must have extensive knowledge of FDA, ICH and EU stability regulatory requirements.  The individual should have the ability to work effectively in a virtual environment utilizing global contract testing laboratories and contract manufacturing organizations. 

 

Specific Responsibilities:

  • For clinical projects and commercial products, provide strategic leadership and operational direction for stability programs performed at a network of Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs).
  • Provide strategic direction and manage to completion stability items for regulatory submissions (BLAs, MAAs, INDs), regulatory meetings, and information request and ensure these are in compliance with applicable global regulatory guidance documents.
  • Work cross-functionally and collaboratively with leadership from manufacturing, supply chain, quality assurance, and project management to ensure timely availability stability data and reports studies.
  • He/she will be responsible for stability planning and justification of budgeting for all for clinical and commercial projects including operating, capital, and staffing costs and tracking of these expenses through the year.
  • Manage the compiling and reporting metrics associated with the stability programs and communicate internally and externally with CTL/CMO.
  • Manage the authorship, review and approval stability protocols, reports.
  • Manage shelf life determination and extensions for all projects using statistical approaches.
  • Manage and lead process improvement activities associated with the stability programs including metrics, KPIs, and CTL performance (logistics, testing data, reporting, investigations) as well as, establish contracts for studies.
  • Manage the compliance of stability function by ensuring appropriate SOPs as developed and maintained.

 

 

Qualifications / Requirements:

Education and/or experience:

•Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 14 years relevant professional experience including 8 years in a combination of quality control and quality control stability in biopharmaceuticals.

•Previous managerial experience is required.

•Demonstrated experience with managing stability programs (early to late to commercial) from for oral and parenteral drug products, devices, and biopharmaceutical (MABs, enzymes,) is required.

•Comprehensive knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (US and EU) as they relate to quality release and stability testing of biopharmaceutical products is required.

•Experience in analytical development, validation, characterization, testing, and stability of natural sourced, recombinant, synthetic is required, while experience in analytical testing of devices is preferred.

•Ability to travel up to 10% of the time

 

Special Skills/Knowledge:

•Ability to provide analytical strategic vision, as well as, effectively prioritize, manage resources, and deliver high-quality results on tight timelines and within budget.

•Self-starter and problem-solver with demonstrated ability to deliver high-quality results in a fast-paced development environment while mentoring, developing, and motivating staff.

•Excellent written and verbal communication skills with immediate team, cross-functionally, as well as executive leadership.

•Excellent cross-functional team skills to accomplish cross-functional initiatives/goals with leaders from quality assurance, manufacturing, supply chain, regulatory affairs, project management, finance, and legal.

•Outstanding problem solving skills including the ability to devise and implement practical solutions to resolve complex issues through improved process, resource management, or new technology.

•Vision, ability to recognize, and implement potential new technologies to meet Aimmune product testing requirements.

•Experience with LIMS and statistical software (JMP and/or Minitab) is required.

 

 

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.

 

 

198396 

 

Summary

The Director Quality Control Stability Program Management will be a strategic leader of the Stability Function and he/she will provide strategic direction, lead, implement, and manage all activities associated with stability Aimmune’s commercial and clinical drug substance and drug products conducted at CTLs/CMOs in food allergy, gastro-intestinal and other therapeutic areas.  The candidate will provide strategic leadership and planning for further development of the stability function to support a robust, challenging, and growing pipeline of clinical programs for products utilizing natural (plant, animal) sourced actives, recombinant proteins, and other therapeutic modalities in different presentations (oral (capsules, sachets), parenteral (liquid) and devices).  While managing a team, the candidate will be responsible for establishing strategic and regulatory appropriate stability strategies for clinical programs from early stage through late stage and commercial products (registrations, post-approval studies).  The individual will also manage all aspects of new and on-going stability programs protocols, reports and data entry into LIMS, data trending using statistical software, shelf-life establishment/update, as well as, investigation into stability quality events.  In addition, the candidate will be responsible for regulatory submissions (stability request for information, stability modules of IND, BLA and MAA), manage implementation/update of SOPs.  Prior experience with commercial and clinical quality control release/stability testing/manufacturing development of pharmaceutical products is required. The candidate must have extensive knowledge of FDA, ICH and EU stability regulatory requirements.  The individual should have the ability to work effectively in a virtual environment utilizing global contract testing laboratories and contract manufacturing organizations. 

 

Specific Responsibilities:

  • For clinical projects and commercial products, provide strategic leadership and operational direction for stability programs performed at a network of Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs).
  • Provide strategic direction and manage to completion stability items for regulatory submissions (BLAs, MAAs, INDs), regulatory meetings, and information request and ensure these are in compliance with applicable global regulatory guidance documents.
  • Work cross-functionally and collaboratively with leadership from manufacturing, supply chain, quality assurance, and project management to ensure timely availability stability data and reports studies.
  • He/she will be responsible for stability planning and justification of budgeting for all for clinical and commercial projects including operating, capital, and staffing costs and tracking of these expenses through the year.
  • Manage the compiling and reporting metrics associated with the stability programs and communicate internally and externally with CTL/CMO.
  • Manage the authorship, review and approval stability protocols, reports.
  • Manage shelf life determination and extensions for all projects using statistical approaches.
  • Manage and lead process improvement activities associated with the stability programs including metrics, KPIs, and CTL performance (logistics, testing data, reporting, investigations) as well as, establish contracts for studies.
  • Manage the compliance of stability function by ensuring appropriate SOPs as developed and maintained.

 

 

Qualifications / Requirements:

Education and/or experience:

•Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 14 years relevant professional experience including 8 years in a combination of quality control and quality control stability in biopharmaceuticals.

•Previous managerial experience is required.

•Demonstrated experience with managing stability programs (early to late to commercial) from for oral and parenteral drug products, devices, and biopharmaceutical (MABs, enzymes,) is required.

•Comprehensive knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (US and EU) as they relate to quality release and stability testing of biopharmaceutical products is required.

•Experience in analytical development, validation, characterization, testing, and stability of natural sourced, recombinant, synthetic is required, while experience in analytical testing of devices is preferred.

•Ability to travel up to 10% of the time

 

Special Skills/Knowledge:

•Ability to provide analytical strategic vision, as well as, effectively prioritize, manage resources, and deliver high-quality results on tight timelines and within budget.

•Self-starter and problem-solver with demonstrated ability to deliver high-quality results in a fast-paced development environment while mentoring, developing, and motivating staff.

•Excellent written and verbal communication skills with immediate team, cross-functionally, as well as executive leadership.

•Excellent cross-functional team skills to accomplish cross-functional initiatives/goals with leaders from quality assurance, manufacturing, supply chain, regulatory affairs, project management, finance, and legal.

•Outstanding problem solving skills including the ability to devise and implement practical solutions to resolve complex issues through improved process, resource management, or new technology.

•Vision, ability to recognize, and implement potential new technologies to meet Aimmune product testing requirements.

•Experience with LIMS and statistical software (JMP and/or Minitab) is required.

 

 

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

Brisbane, CA, US, 94005


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Apply now »