ASSOCIATE DIRECTOR, GPS STABILITY
Bristol-Myers Squibb
ASSOCIATE DIRECTOR, GPS STABILITY
Job Description
The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products. Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization. Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change. Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group. Provides technical expertise to the stability team. Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries. Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews. Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues. Accountable for stability procedures and ensures consistency with site department and BMS groups procedures. Leads OpEx initiatives to streamline and standardize management of stability programs. Supports health authorities' inspection internal and external. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching. Leads with a global mind-set to direct and influence multiple remote teams Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives Accountable for stability resources definition and budget. Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors. Provides continuing development opportunities, including ongoing performance assessments 10 years of relevant work experience required, preferably in a pharmaceutical environment. 2 years' experience as team manager. Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles. Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions. Significant experience on health authorities' inspections in front room. Excellent written and verbal communication skills. Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).
Key Responsibilities
- Accountable for the stability commercial program for large molecules Drug Substances and Drug Products
- Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization
- Serves as stability representative on project teams covering post-approval changes
- Designs and executes required premarket stability program in support of the change
- Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group
- Provides technical expertise to the stability team
- Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries
- Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews
- Provides support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues
- Accountable for stability procedures and ensures consistency with site department and BMS groups procedures
- Leads OpEx initiatives to streamline and standardize management of stability programs
- Supports health authorities' inspection internal and external
- Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
- Leads with a global mind-set to direct and influence multiple remote teams
- Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
- Accountable for stability resources definition and budget
- Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors
- Provides continuing development opportunities, including ongoing performance assessments
Required Qualifications
- 0 years of relevant work experience, preferably in a pharmaceutical environment
- years' experience as team manager
- Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents
- Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility
- Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices
- Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
Skills Required
- Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
- Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions
- Significant experience on health authorities' inspections in front room
- Excellent written and verbal communication skills
- Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation
- Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP)
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
- Supporting People with Disabilities
Locations
- Devens MA, United States
- New Brunswick NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principlesintermediate
- Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutionsintermediate
- Significant experience on health authorities' inspections in front roomintermediate
- Excellent written and verbal communication skillsintermediate
- Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocationintermediate
- Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP)intermediate
Required Qualifications
- 0 years of relevant work experience, preferably in a pharmaceutical environment (experience)
- years' experience as team manager (experience)
- Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents (experience)
- Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility (experience)
- Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices (experience)
- Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods (experience)
Responsibilities
- Accountable for the stability commercial program for large molecules Drug Substances and Drug Products
- Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization
- Serves as stability representative on project teams covering post-approval changes
- Designs and executes required premarket stability program in support of the change
- Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group
- Provides technical expertise to the stability team
- Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries
- Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews
- Provides support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues
- Accountable for stability procedures and ensures consistency with site department and BMS groups procedures
- Leads OpEx initiatives to streamline and standardize management of stability programs
- Supports health authorities' inspection internal and external
- Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
- Leads with a global mind-set to direct and influence multiple remote teams
- Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
- Accountable for stability resources definition and budget
- Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors
- Provides continuing development opportunities, including ongoing performance assessments
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
- general: Supporting People with Disabilities
Tags & Categories
ASSOCIATE DIRECTOR, GPS STABILITY
Bristol-Myers Squibb
ASSOCIATE DIRECTOR, GPS STABILITY
Job Description
The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products. Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization. Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change. Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group. Provides technical expertise to the stability team. Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries. Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews. Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues. Accountable for stability procedures and ensures consistency with site department and BMS groups procedures. Leads OpEx initiatives to streamline and standardize management of stability programs. Supports health authorities' inspection internal and external. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching. Leads with a global mind-set to direct and influence multiple remote teams Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives Accountable for stability resources definition and budget. Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors. Provides continuing development opportunities, including ongoing performance assessments 10 years of relevant work experience required, preferably in a pharmaceutical environment. 2 years' experience as team manager. Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles. Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions. Significant experience on health authorities' inspections in front room. Excellent written and verbal communication skills. Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).
Key Responsibilities
- Accountable for the stability commercial program for large molecules Drug Substances and Drug Products
- Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization
- Serves as stability representative on project teams covering post-approval changes
- Designs and executes required premarket stability program in support of the change
- Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group
- Provides technical expertise to the stability team
- Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries
- Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews
- Provides support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues
- Accountable for stability procedures and ensures consistency with site department and BMS groups procedures
- Leads OpEx initiatives to streamline and standardize management of stability programs
- Supports health authorities' inspection internal and external
- Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
- Leads with a global mind-set to direct and influence multiple remote teams
- Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
- Accountable for stability resources definition and budget
- Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors
- Provides continuing development opportunities, including ongoing performance assessments
Required Qualifications
- 0 years of relevant work experience, preferably in a pharmaceutical environment
- years' experience as team manager
- Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents
- Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility
- Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices
- Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
Skills Required
- Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
- Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions
- Significant experience on health authorities' inspections in front room
- Excellent written and verbal communication skills
- Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation
- Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP)
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
- Supporting People with Disabilities
Locations
- Devens MA, United States
- New Brunswick NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principlesintermediate
- Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutionsintermediate
- Significant experience on health authorities' inspections in front roomintermediate
- Excellent written and verbal communication skillsintermediate
- Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocationintermediate
- Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP)intermediate
Required Qualifications
- 0 years of relevant work experience, preferably in a pharmaceutical environment (experience)
- years' experience as team manager (experience)
- Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents (experience)
- Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility (experience)
- Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices (experience)
- Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods (experience)
Responsibilities
- Accountable for the stability commercial program for large molecules Drug Substances and Drug Products
- Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization
- Serves as stability representative on project teams covering post-approval changes
- Designs and executes required premarket stability program in support of the change
- Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group
- Provides technical expertise to the stability team
- Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries
- Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews
- Provides support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues
- Accountable for stability procedures and ensures consistency with site department and BMS groups procedures
- Leads OpEx initiatives to streamline and standardize management of stability programs
- Supports health authorities' inspection internal and external
- Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
- Leads with a global mind-set to direct and influence multiple remote teams
- Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
- Accountable for stability resources definition and budget
- Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors
- Provides continuing development opportunities, including ongoing performance assessments
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
- general: Supporting People with Disabilities
Tags & Categories