Assistant Production Manager, Cell Therapy External - Summit, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

Summit, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

Job Summary

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

General and team
Function as a key point of contact for designated BMS interests/activities at Contract Manufacturing Organizations (CMOs).
Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders, developing a partnership approach.
Live and support deployment of the BMS values.
Act as a resource for CMO stakeholders on their requests to BMS stakeholders and vice versa.
Production
Provide operational support to VPT / SRMs to ensure all deliverables meet or exceed BMS requirements. This includes but is not limited to ensuring compliant and timely manufacturing, OTIF shipments, quality compliance and cost management) be the BMS 'eyes and ears' at the CMO for flawless execution of commercial operations.
Leverage BMS VPT stakeholders to provide guidance to CMOs and ensure crossfunctional alignment on priorities and deliverables.
Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
In close relation with CMO and BMS VPT stakeholders, lead, prioritize and track efficient execution and documentation of key activities to meet BMS requirements. This includes, but is not limited to initiation, execution, tracking and closure of change controls, investigations, and deviations.
Identify and escalate businesscritical issues effecting Compliance, Operations and Management
Participate in regular staff and governance meetings to agree on priorities and tactics.
Maintain and communicate list of unbudgeted and extraordinary charges for resolution with CMO and visibility to management.
Project management
Manage a portfolio of multiple crossfunctional external manufacturing projects, with a focus on developing and maintaining overall project plan objectives and timelines.
Collaborate with CMO and internal stakeholders to understand planned changes, set priorities, define required budget and resources, and manage the endtoend implementation process including but not limited to change controls and impact assessments.
Support product, technical and business process lifecycle management activities.
Lead or support other CMO or VPTrelated projects.
Performance and continuous improvement
Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
Facilitate collation of data to track CMO and VPT performance and compliance on metrics including but not limited to adherence to contractual agreements such as ontimeinfull (OTIF) delivery and release, spend/budget, product quality and supply integrity.
Facilitate process improvement initiatives with CMO, VPT and supporting business processes.
Track and ensure compliant and timely execution and closure of responses to audit and inspection observations or of other regulatory commitments.
Create and maintain process maps and tools, maintain related SOPs and work instructions up to date, in collaboration with other VPT representatives.
Collaborate with other VPTs to exchange experience and best practices.
Support root cause analysis and risk assessments.

Required Qualifications

Bachelor's degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
Advanced degree in Life Sciences preferred.
3+ years of experience working in biopharmaceutical manufacturing, quality, or biopharmaceutical development.
Background in a commercial GMP operational environment; sound working knowledge of health authority regulations.
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.
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