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Manager, Person in Plant External Manufacturing

Company: Bristol Myers Squibb
Location: Irving
Posted on: June 9, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Location: Houston, TX

Job Summary

The primary focus of the Person-in-Plant, External Manufacturing role is to oversee Celgene's critical cell processing Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell manufacturing. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located at the cell processing CMO's site for extended periods of time with a requirement to travel elsewhere as needed. The successful candidate will be a key member of the Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

As we are "changing medicine for good," we are looking for leaders who can work in a highly matrixed and cross-functional organizations, against tight deadlines, and with world-class contract manufacturers and business leaders alike.

Primary Responsibilities

  • Function as the first/primary point of contact for all BMS interests/activities at Contract Manufacturing Organizations (CMOs)
  • Provide operational oversight of CMOs to ensure all deliverables meet or exceed BMS requirements (including but not limited to OTIF shipments, quality compliance and cost management) - be the BMS 'eyes and ears' at the CMO for flawless execution of commercial operations
  • Maintain on-site presence at the CMO facility for extended periods (including some off-hours days to resolve urgent issues), leading up to and during batch manufacturing
  • Liaison with internal and CMO stakeholders on business operations including but not limited to contract negotiations, forecast communication, issuance of POs and reconciliation/validation of invoices
  • Leverage technical, quality and regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables
  • Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing
  • Work closely with CMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations and deviations) to meet BMS requirements
  • Act as the key liaison to facilitate post-campaign and CAPA effectiveness review at CMOs
  • Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
  • Collaborate with CMO and internal stakeholders to understand planned change and manage the E-2-E implementation process including but not limited to change controls and impact assessments.
  • Facilitate collation of data to track CMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, spend/budget, product quality and supply integrity
  • Identify and escalate business-critical issues effecting Compliance, Operations and Management.
  • Lead continuous improvement initiatives to affect timely resolution of supply issues.
  • Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders.
  • Act as a resource for CMO stakeholders on their requests to BMS stakeholders
  • Live the BMS values.

Required Qualifications

  • Bachelor's degree required, ideally in; cell biology, or closely related disciplines.
  • 5+ years of experience working in biopharmaceutical manufacturing, quality, or biopharmaceutical development.
  • Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations
  • Strong technical background in aseptic operations.
  • Solid project management skills and experience managing complex projects.
  • Ability to expresses one's self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
  • Strong leadership and an innate ability to collaborate and build relationships is critical.
  • Ability to work calmly and make sound decisions in an environment of uncertainty and change
  • Flexibility to work shift hours required to cover critical process steps
  • Represent BMS as a leader when issues arise.

Education Requirements

  • Bachelor's degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
  • Advanced degree in Life Sciences preferred.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Job Summary

The primary focus of the Person-in-Plant, External Manufacturing role is to oversee Celgene's critical cell processing Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell manufacturing. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located at the cell processing CMO's site for extended periods of time with a requirement to travel elsewhere as needed. The successful candidate will be a key member of the Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

As we are "changing medicine for good," we are looking for leaders who can work in a highly matrixed and cross-functional organizations, against tight deadlines, and with world-class contract manufacturers and business leaders alike.

Primary Responsibilities

  • Function as the first/primary point of contact for all BMS interests/activities at Contract Manufacturing Organizations (CMOs)
  • Provide operational oversight of CMOs to ensure all deliverables meet or exceed BMS requirements (including but not limited to OTIF shipments, quality compliance and cost management) - be the BMS 'eyes and ears' at the CMO for flawless execution of commercial operations
  • Maintain on-site presence at the CMO facility for extended periods (including some off-hours days to resolve urgent issues), leading up to and during batch manufacturing
  • Liaison with internal and CMO stakeholders on business operations including but not limited to contract negotiations, forecast communication, issuance of POs and reconciliation/validation of invoices
  • Leverage technical, quality and regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables
  • Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing
  • Work closely with CMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations and deviations) to meet BMS requirements
  • Act as the key liaison to facilitate post-campaign and CAPA effectiveness review at CMOs
  • Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
  • Collaborate with CMO and internal stakeholders to understand planned change and manage the E-2-E implementation process including but not limited to change controls and impact assessments.
  • Facilitate collation of data to track CMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, spend/budget, product quality and supply integrity
  • Identify and escalate business-critical issues effecting Compliance, Operations and Management.
  • Lead continuous improvement initiatives to affect timely resolution of supply issues.
  • Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders.
  • Act as a resource for CMO stakeholders on their requests to BMS stakeholders
  • Live the BMS values.

Required Qualifications

  • Bachelor's degree required, ideally in; cell biology, or closely related disciplines.
  • 5+ years of experience working in biopharmaceutical manufacturing, quality, or biopharmaceutical development.
  • Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations
  • Strong technical background in aseptic operations.
  • Solid project management skills and experience managing complex projects.
  • Ability to expresses one's self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
  • Strong leadership and an innate ability to collaborate and build relationships is critical.
  • Ability to work calmly and make sound decisions in an environment of uncertainty and change
  • Flexibility to work shift hours required to cover critical process steps
  • Represent BMS as a leader when issues arise.

Education Requirements

  • Bachelor's degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
  • Advanced degree in Life Sciences preferred.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Keywords: Bristol Myers Squibb, Irving , Manager, Person in Plant External Manufacturing, Other , Irving, Texas

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