Associate Director, Upstream Clinical Manufacturing
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
Reporting to the Director, Devens Clinical Manufacturing, the Associate Director of Upstream Clinical Manufacturing is responsible for advancing the mid to late stage clinical pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs).
The Clinical Manufacturing Building (CMB) is a brand new, state of the art facility utilizing single-use technology.
Key responsibilities include but are not limited to:
Recruits and develops a high performing team with diverse backgrounds and talents.
Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
Manages upstream production by providing direction and guidance to operational staff in their daily contributions to the manufacturing process.
Communicates resource needs from the supporting organizations (QA/QC, Supply Chain, Human Resources, Technical Services, etc.
) as needed to support the core manufacturing process.
In collaboration with partnering groups, oversees preparation and implementation for the tech transfer of new products into the Clinical Manufacturing Building.
Additionally, implement a product changeover program that allows for rapid changeover between products Establishes an environment which fosters safety, quality and continuous improvement in cost and customer service.
Maintains and communicates performance metrics to her/his team, setting and maintaining high expectations for team performance.
Implements practices to keep the Clinical Manufacturing Building in an inspection ready state and represents manufacturing during intern Qualifications Minimum of a Bachelor's in science, engineering or biochemistry with at least 10 years relevant experience in a cell culture biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Previous supervisory experience preferred and prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Demonstrated good interpersonal and communication skills.
Experience with managing tech transfers of new products into a clinical manufacturing facility and knowledge of single-use equipment is desirable.
Previous experience with Operation Excellence is a plus.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501044.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
Reporting to the Director, Devens Clinical Manufacturing, the Associate Director of Upstream Clinical Manufacturing is responsible for advancing the mid to late stage clinical pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs).
The Clinical Manufacturing Building (CMB) is a brand new, state of the art facility utilizing single-use technology.
Key responsibilities include but are not limited to:
Recruits and develops a high performing team with diverse backgrounds and talents.
Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
Manages upstream production by providing direction and guidance to operational staff in their daily contributions to the manufacturing process.
Communicates resource needs from the supporting organizations (QA/QC, Supply Chain, Human Resources, Technical Services, etc.
) as needed to support the core manufacturing process.
In collaboration with partnering groups, oversees preparation and implementation for the tech transfer of new products into the Clinical Manufacturing Building.
Additionally, implement a product changeover program that allows for rapid changeover between products Establishes an environment which fosters safety, quality and continuous improvement in cost and customer service.
Maintains and communicates performance metrics to her/his team, setting and maintaining high expectations for team performance.
Implements practices to keep the Clinical Manufacturing Building in an inspection ready state and represents manufacturing during intern Qualifications Minimum of a Bachelor's in science, engineering or biochemistry with at least 10 years relevant experience in a cell culture biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Previous supervisory experience preferred and prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Demonstrated good interpersonal and communication skills.
Experience with managing tech transfers of new products into a clinical manufacturing facility and knowledge of single-use equipment is desirable.
Previous experience with Operation Excellence is a plus.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501044.
Estimated Salary: $20 to $28 per hour based on qualifications.
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