Associate Director, Upstream
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.
The Group Leader reports to the Director of MS&T and is in direct contact with other senior leaders, including members of Process Development, Analytical, Quality, EH&S, and Manufacturing.
A frequent interaction with stakeholders on other BMS sites and external industry and regulatory representatives is expected.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
Typical activities include problem solving of process related investigations, the preparation of study protocols and reports, the evaluation of new process technologies through the use of scale-down models and in depth understanding of data from manufacturing.
Ensures budgets, schedules, and performance requirements are met.
Assignment is in a modern Biologics Development Building at Devens, MA.
The position will be temporarily based in Hopkinton, MA and requires routine travel between our Hopkinton and Devens sites.
The Downstream group leader is expected to have a strong presence in the lab and balance his time between the lab and office space, based on business priorities.
Responsibilities include but are not limited to:
Directs all components of the Upstream group within Devens Drug Substance MS&T.
The successful candidate will lead a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and timely delivering results.
As DS MS&T, we participate in cross-functional teams and also work independently to meet high-visibility critical business objectives Accountable to optimize resources to design, execution and analysis of seed train, bioreactor and harvest experiments and their interpretation.
Sets high standards to assure compliance with BMS Directives including safety, staff training, cGMPs and quality systems documentation.
May represent the Devens site during regulatory agency inspections.
Routinely liaises with MS&T Process Champions, Biologics External Manufacturing, and Devens Manufacturing Technology regarding strategies for technical and operational improvements, investigation resolution, process validation, and laboratory troubleshooting.
Invests in the growth of the Upstream group, including current and future leadership, through assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition.
Establishes business objectives for Upstream, consistent with BMS' biologics strategy.
Establishes high performance standards, defines clear accountability, and leads by developing, adopting and supporting continuous improvement.
Actively communicates group's activities and progress through varied technical and non-technical forums.
Qualifications Ph.
D.
with a least 7 years directly related experience OR a Master's degree with at least 10 years directly related experience OR a Bachelor's degree with at least 12 years directly related experiences.
Documented solid history of technical accomplishments in the cell culture field, e.
g.
relevant experience in upstream process development or upstream manufacturing technical support.
Experience in the design, modification and optimization of biologics cell culture or fermentation seed and bioreactor operation, with a strong practical knowledge of the technologies related to mammalian cell culture or fermentation with clear awareness of current industry trends.
Experienced in development and technology transfer of processes for commercial biologic manufacturing.
Excellent verbal & written communications skills.
In-depth knowledge of regulatory requirements for filing Biologics in the US and Europe including past productive interactions with US and European regulatory agencies for the development and manufacture of biologics.
Direct involvement in securing a BLA, or sBLA regulatory filing of a commercial facility or process.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1500369.
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.
The Group Leader reports to the Director of MS&T and is in direct contact with other senior leaders, including members of Process Development, Analytical, Quality, EH&S, and Manufacturing.
A frequent interaction with stakeholders on other BMS sites and external industry and regulatory representatives is expected.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
Typical activities include problem solving of process related investigations, the preparation of study protocols and reports, the evaluation of new process technologies through the use of scale-down models and in depth understanding of data from manufacturing.
Ensures budgets, schedules, and performance requirements are met.
Assignment is in a modern Biologics Development Building at Devens, MA.
The position will be temporarily based in Hopkinton, MA and requires routine travel between our Hopkinton and Devens sites.
The Downstream group leader is expected to have a strong presence in the lab and balance his time between the lab and office space, based on business priorities.
Responsibilities include but are not limited to:
Directs all components of the Upstream group within Devens Drug Substance MS&T.
The successful candidate will lead a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and timely delivering results.
As DS MS&T, we participate in cross-functional teams and also work independently to meet high-visibility critical business objectives Accountable to optimize resources to design, execution and analysis of seed train, bioreactor and harvest experiments and their interpretation.
Sets high standards to assure compliance with BMS Directives including safety, staff training, cGMPs and quality systems documentation.
May represent the Devens site during regulatory agency inspections.
Routinely liaises with MS&T Process Champions, Biologics External Manufacturing, and Devens Manufacturing Technology regarding strategies for technical and operational improvements, investigation resolution, process validation, and laboratory troubleshooting.
Invests in the growth of the Upstream group, including current and future leadership, through assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition.
Establishes business objectives for Upstream, consistent with BMS' biologics strategy.
Establishes high performance standards, defines clear accountability, and leads by developing, adopting and supporting continuous improvement.
Actively communicates group's activities and progress through varied technical and non-technical forums.
Qualifications Ph.
D.
with a least 7 years directly related experience OR a Master's degree with at least 10 years directly related experience OR a Bachelor's degree with at least 12 years directly related experiences.
Documented solid history of technical accomplishments in the cell culture field, e.
g.
relevant experience in upstream process development or upstream manufacturing technical support.
Experience in the design, modification and optimization of biologics cell culture or fermentation seed and bioreactor operation, with a strong practical knowledge of the technologies related to mammalian cell culture or fermentation with clear awareness of current industry trends.
Experienced in development and technology transfer of processes for commercial biologic manufacturing.
Excellent verbal & written communications skills.
In-depth knowledge of regulatory requirements for filing Biologics in the US and Europe including past productive interactions with US and European regulatory agencies for the development and manufacture of biologics.
Direct involvement in securing a BLA, or sBLA regulatory filing of a commercial facility or process.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1500369.
Estimated Salary: $20 to $28 per hour based on qualifications.
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