- 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 cross-functional 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 business-critical 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 cross-functional 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 end-to-end 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 VPT-related 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 on-time-in-full (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.
- 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.
- Represent BMS as a leader when issues arise.
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Assistant Production Manager, Cell Therapy External Manufacturing - Ayer, United States - Bristol-Myers Squibb
Description
Working with UsChallenging. 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: .
Job Summary
The primary focus of the Assistant Production Manager, External Manufacturing role is to assist in coordinating and tracking manufacturing activities at specific BMS's Contract Manufacturing Organizations (CMOs). We are looking for a candidate with the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of concerned products. The right candidate should have the ability to understand the challenges and facilitate cross-functional dialogue to determine impact. The successful candidate should have an interest in developing skills across the GPS matrix including operational, quality, compliance, and technical, along with project management and supplier management. 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
#VETERAN
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 . Visit 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
