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. 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: careers.bms.com/working-with-us.
Position Summary:
- Provide technical support and leadership to the External Manufacturing for Oral Solid Dosage (OSD)
- Organisation and Contract Manufacturing Organisations (CMOs).
- Ensure the transfer of robust manufacturing processes, including packaging and artwork
- Ensure robust process performance during OSD commercial manufacture by use of continuous process verification and OPEX
Responsibilities:
- Provision of ongoing technical support and oversight for a portfolio of Active Pharmaceutical Ingredients (APIs), Intermediates and Starting Materials and/or Oral Drug Products, Packaging and artwork, ensuring compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement
- Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required
- Helping CMO/vendor selection – prepare technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs)
- Managing technology transfers as needed
- Technical oversight and direction for process validation, as needed
- Providing technical guidance in the understanding of root causes and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for API / intermediate / starting material manufacturing and/or OSD ,Packaging and Artwork processes
- Driving the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing/packaging/artwork, technical transfer and scale-up of processes
- Provide support for change management
- Support all regulatory activities associated with changes to assigned products and new products
- Support operational management of CMO as per Supplier Relationship Management governance structure
- Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.
- Product robustness (where required) - technical lead for creation of process robustness monitoring plan, process control strategy, and provision of technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.
- Where required develop programme of experimental work to support investigations and work with PD, CMOs and external resources as appropriate to implement the programme of work.
cGMP Responsibilities/Critical Tasks
- Documentation (Transfer documentation, Appraisals, technical memos and reports, Regulatory filing, etc.)
- Deviation investigations
- Technical support for Change Control system
- Training Gap Analysis and Planning
Required Competencies:
- Expert knowledge in one or more of the following areas:
- Drug Product - Oral Solid Dosage products technology transfer and manufacturing support (change control, investigations, process optimisation)
- Packaging, artwork and/or device manufacturing
- Understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing,
- Environmental Health and Safety (EHS)) aspects of API and/or drug product (DP) manufacture and/or Packaging.
- Demonstrated project management and technical leadership capability.
- Demonstrated capability in the use of standard tools for root cause analysis. Ability to close-out investigations and issues at CMOs.
- Understanding of statistical process analysis and control methods. Ability to use statistical software to analyse process related data to established process capability or for troubleshooting purposes
- Proven experience of technology transfer process
- Excellent verbal, written communications and presentations skills, to include the ability to document complex study plans and scientific reports; notifications to line management about critical issues related to product manufacturing and process validation where appropriate.
- Strong communication and skills of negotiation as well as the ability to translate technical issues into business impact and relevant solutions.
- Ability to work on own and as part of a team and to drive issues to resolution
Required Qualification(s) and Desired Experience:
- A graduate or post-graduate level qualification in chemistry, chemical engineering or related field.
- A minimum of five (5) years for OSD industrial experience
- Proven record in pharmaceutical technology - pharmaceutical process scale-up, technical transfer and manufacturing/packaging/artwork support/activities
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.
New Brunswick - NJ - US: $112,840 - $136,733
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 a supportive culture, promoting global participation 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 an 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 adastaffingsupport@bms.com. Visit careers.bms.com/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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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