Manager, Senior Scientist, Quality Control Laboratory
Bristol-Myers Squibb
Manager, Senior Scientist, Quality Control Laboratory
Job Description
Designated Subject matter expert for a number of test methods/processes across multiple products Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction May own scheduling of assignments in consultation with manager. Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines. Represent the department in product review boards and regulatory inspections (internal and external audits). May author responses to regulatory requests. Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts. Anticipate and perform complex troubleshooting and problem solving independently. May represent the department in regulatory inspections (internal and external audits). Train and mentor others on multiple QC test methods, processes and procedures. Perform other tasks as assigned. Owns and contributes to change controls. May act as delegate for laboratory management, as required. Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation. Champion and foster a positive, supportive, and collaborative quality culture. Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion). Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely. Demonstrated advanced technical writing skills. High problem-solving ability/mentality, technically adept and logical. Excellent attention to detail and demonstrated organizational skills. Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English Demonstrated strategic & enterprise thinking Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced use and knowledge of LIMS, ELN and laboratory data analysis. Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Bachelors Degree in a non-technical discipline with ≥13 years experience, or Bachelors Degree in a Scientific or relevant Technical area with ≥9 years experience, or Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or PhD in a Scientific or relevant Technical area with ≥5 years relevant experience. Able to write, read, and speak English fluently An equivalent combination of education and experience, preferably in a regulated environment will be considered.
Key Responsibilities
- Designated Subject matter expert for a number of test methods/processes across multiple products
- Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
- Own scheduling of assignments in consultation with manager
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines
- Represent the department in product review boards and regulatory inspections (internal and external audits)
- Author responses to regulatory requests
- Lead projects, CAPAs and deviations/investigations and/or continuous improvement efforts
- Anticipate and perform complex troubleshooting and problem solving independently
- Train and mentor others on multiple QC test methods, processes and procedures
- Perform other tasks as assigned
- Owns and contributes to change controls
- Act as delegate for laboratory management, as required
- Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
- Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation
- Champion and foster a positive, supportive, and collaborative quality culture
- Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
- Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)
Required Qualifications
- Bachelor's Degree in a non-technical discipline with ≥13 years experience
- Bachelor's Degree in a Scientific or relevant Technical area with ≥9 years experience
- Master's Degree in a Scientific or relevant Technical area with ≥7 years relevant experience
- PhD in a Scientific or relevant Technical area with ≥5 years relevant experience
- Able to write, read, and speak English fluently
- An equivalent combination of education and experience, preferably in a regulated environment
Skills Required
- Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely
- Demonstrated advanced technical writing skills
- High problem-solving ability/mentality, technically adept and logical
- Excellent attention to detail and demonstrated organizational skills
- Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English
- Demonstrated strategic & enterprise thinking
- Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
- Advanced use and knowledge of LIMS, ELN and laboratory data analysis
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills
Locations
- Aichi, Japan
Salary
Estimated Salary Rangemedium confidence
8,000,000 - 12,000,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completelyintermediate
- Demonstrated advanced technical writing skillsintermediate
- High problem-solving ability/mentality, technically adept and logicalintermediate
- Excellent attention to detail and demonstrated organizational skillsintermediate
- Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in Englishintermediate
- Demonstrated strategic & enterprise thinkingintermediate
- Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Advanced use and knowledge of LIMS, ELN and laboratory data analysisintermediate
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's Degree in a non-technical discipline with ≥13 years experience (experience)
- Bachelor's Degree in a Scientific or relevant Technical area with ≥9 years experience (experience)
- Master's Degree in a Scientific or relevant Technical area with ≥7 years relevant experience (experience)
- PhD in a Scientific or relevant Technical area with ≥5 years relevant experience (experience)
- Able to write, read, and speak English fluently (experience)
- An equivalent combination of education and experience, preferably in a regulated environment (experience)
Responsibilities
- Designated Subject matter expert for a number of test methods/processes across multiple products
- Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
- Own scheduling of assignments in consultation with manager
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines
- Represent the department in product review boards and regulatory inspections (internal and external audits)
- Author responses to regulatory requests
- Lead projects, CAPAs and deviations/investigations and/or continuous improvement efforts
- Anticipate and perform complex troubleshooting and problem solving independently
- Train and mentor others on multiple QC test methods, processes and procedures
- Perform other tasks as assigned
- Owns and contributes to change controls
- Act as delegate for laboratory management, as required
- Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
- Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation
- Champion and foster a positive, supportive, and collaborative quality culture
- Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
- Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)
Tags & Categories
Manager, Senior Scientist, Quality Control Laboratory
Bristol-Myers Squibb
Manager, Senior Scientist, Quality Control Laboratory
Job Description
Designated Subject matter expert for a number of test methods/processes across multiple products Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction May own scheduling of assignments in consultation with manager. Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines. Represent the department in product review boards and regulatory inspections (internal and external audits). May author responses to regulatory requests. Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts. Anticipate and perform complex troubleshooting and problem solving independently. May represent the department in regulatory inspections (internal and external audits). Train and mentor others on multiple QC test methods, processes and procedures. Perform other tasks as assigned. Owns and contributes to change controls. May act as delegate for laboratory management, as required. Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation. Champion and foster a positive, supportive, and collaborative quality culture. Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion). Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely. Demonstrated advanced technical writing skills. High problem-solving ability/mentality, technically adept and logical. Excellent attention to detail and demonstrated organizational skills. Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English Demonstrated strategic & enterprise thinking Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced use and knowledge of LIMS, ELN and laboratory data analysis. Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Bachelors Degree in a non-technical discipline with ≥13 years experience, or Bachelors Degree in a Scientific or relevant Technical area with ≥9 years experience, or Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or PhD in a Scientific or relevant Technical area with ≥5 years relevant experience. Able to write, read, and speak English fluently An equivalent combination of education and experience, preferably in a regulated environment will be considered.
Key Responsibilities
- Designated Subject matter expert for a number of test methods/processes across multiple products
- Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
- Own scheduling of assignments in consultation with manager
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines
- Represent the department in product review boards and regulatory inspections (internal and external audits)
- Author responses to regulatory requests
- Lead projects, CAPAs and deviations/investigations and/or continuous improvement efforts
- Anticipate and perform complex troubleshooting and problem solving independently
- Train and mentor others on multiple QC test methods, processes and procedures
- Perform other tasks as assigned
- Owns and contributes to change controls
- Act as delegate for laboratory management, as required
- Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
- Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation
- Champion and foster a positive, supportive, and collaborative quality culture
- Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
- Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)
Required Qualifications
- Bachelor's Degree in a non-technical discipline with ≥13 years experience
- Bachelor's Degree in a Scientific or relevant Technical area with ≥9 years experience
- Master's Degree in a Scientific or relevant Technical area with ≥7 years relevant experience
- PhD in a Scientific or relevant Technical area with ≥5 years relevant experience
- Able to write, read, and speak English fluently
- An equivalent combination of education and experience, preferably in a regulated environment
Skills Required
- Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely
- Demonstrated advanced technical writing skills
- High problem-solving ability/mentality, technically adept and logical
- Excellent attention to detail and demonstrated organizational skills
- Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English
- Demonstrated strategic & enterprise thinking
- Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
- Advanced use and knowledge of LIMS, ELN and laboratory data analysis
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills
Locations
- Aichi, Japan
Salary
Estimated Salary Rangemedium confidence
8,000,000 - 12,000,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completelyintermediate
- Demonstrated advanced technical writing skillsintermediate
- High problem-solving ability/mentality, technically adept and logicalintermediate
- Excellent attention to detail and demonstrated organizational skillsintermediate
- Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in Englishintermediate
- Demonstrated strategic & enterprise thinkingintermediate
- Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Advanced use and knowledge of LIMS, ELN and laboratory data analysisintermediate
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's Degree in a non-technical discipline with ≥13 years experience (experience)
- Bachelor's Degree in a Scientific or relevant Technical area with ≥9 years experience (experience)
- Master's Degree in a Scientific or relevant Technical area with ≥7 years relevant experience (experience)
- PhD in a Scientific or relevant Technical area with ≥5 years relevant experience (experience)
- Able to write, read, and speak English fluently (experience)
- An equivalent combination of education and experience, preferably in a regulated environment (experience)
Responsibilities
- Designated Subject matter expert for a number of test methods/processes across multiple products
- Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
- Own scheduling of assignments in consultation with manager
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines
- Represent the department in product review boards and regulatory inspections (internal and external audits)
- Author responses to regulatory requests
- Lead projects, CAPAs and deviations/investigations and/or continuous improvement efforts
- Anticipate and perform complex troubleshooting and problem solving independently
- Train and mentor others on multiple QC test methods, processes and procedures
- Perform other tasks as assigned
- Owns and contributes to change controls
- Act as delegate for laboratory management, as required
- Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
- Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation
- Champion and foster a positive, supportive, and collaborative quality culture
- Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
- Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)
Tags & Categories