Director, CMC Team Leader - Bristol Myers Squibb
Princeton, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities. You'll make a positive impact on the lives of patients while advancing professionally alongside some of the brightest minds in biopharma.
The Director, CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs .
Primary responsibilities of the Director, CMC Team Leader:
+ Provides leadership to interdisciplinary, matrix teams responsible for developing and executing compound-specific integrated CMC strategies that drive R&D Project Team objectives and incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical material spaces.
+ Accountable for managing multiple assets, large molecule and/or small molecule, ranging from candidate nomination, First-in-Human, and pivotal clinical studies, to intended commercial formulation and manufacturing processes with appropriate control strategies.
+ Represents the Product Development organization on R&D Project Teams and actively collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company.
+ Communicates and partners effectively with functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute CMC strategy for the project. Identifies and escalates key issues and risks as well as resource allocation needs, as appropriate
+ Critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
+ Promotes best practices and leads improvement opportunities.
+ Partners with the GPS Business development group to support Due Diligence evaluations and activities to bring assets into the GPS network, will partner with alliance management, as necessary.
Skills/Knowledge Required:
+ Advanced degree in relevant scientific discipline
+ 12+ years of relevant CMC experience in the pharmaceutical industry.
+ Broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development of clinical stage programs
+ Experience in multiple modalities is a clear plus.
+ Solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development.
+ Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose
+ Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
+ Keen sense for value of investment, ability to manage ambiguity and make decisions with limited information, when required
+ Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585778
Updated: 2024-09-30 06:06:21.732 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities. You'll make a positive impact on the lives of patients while advancing professionally alongside some of the brightest minds in biopharma.
The Director, CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs .
Primary responsibilities of the Director, CMC Team Leader:
+ Provides leadership to interdisciplinary, matrix teams responsible for developing and executing compound-specific integrated CMC strategies that drive R&D Project Team objectives and incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical material spaces.
+ Accountable for managing multiple assets, large molecule and/or small molecule, ranging from candidate nomination, First-in-Human, and pivotal clinical studies, to intended commercial formulation and manufacturing processes with appropriate control strategies.
+ Represents the Product Development organization on R&D Project Teams and actively collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company.
+ Communicates and partners effectively with functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute CMC strategy for the project. Identifies and escalates key issues and risks as well as resource allocation needs, as appropriate
+ Critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
+ Promotes best practices and leads improvement opportunities.
+ Partners with the GPS Business development group to support Due Diligence evaluations and activities to bring assets into the GPS network, will partner with alliance management, as necessary.
Skills/Knowledge Required:
+ Advanced degree in relevant scientific discipline
+ 12+ years of relevant CMC experience in the pharmaceutical industry.
+ Broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development of clinical stage programs
+ Experience in multiple modalities is a clear plus.
+ Solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development.
+ Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose
+ Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
+ Keen sense for value of investment, ability to manage ambiguity and make decisions with limited information, when required
+ Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585778
Updated: 2024-09-30 06:06:21.732 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb