JOB FUNCTION- Provide technical support and leadership to the External Manufacturing Organization and Contract Manufacturing Organizations (CMOs).
- Provide technical support and leadership to the BMS Internal Manufacturing Organization.
- Ensure the transfer of robust manufacturing processes.
- Ensure robust process performance during commercial manufacture by use of continuous process monitoring and OPEX.
DUTIES/RESPONSIBILITIES- Provision of ongoing technical support and oversight for a portfolio of Drug Products, 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
- Supporting CMO/vendor selection - preparation of 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 required
- Technical oversight and direction for process validation, as required
- 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 DP processes
- Driving the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes
- Work with assigned CMOs and/ or internal site to identify and agree potential process optimizations
- Reduce costs associated with existing processes
- Participate and lead on teams for cost reduction projects
- 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), Internal manufacturing site (as applicable), 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 program of experimental work to support investigations and work with PD, CMOs and external resources as appropriate to implement the program 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
- Technical support for Validation and Continued Process Verification (CPV)
- Training Gap Analysis and Planning
QUALIFICATIONSRequired Competencies:The role holder will have expert knowledge in one or more of the following areas:
- Drug Product - Oral Solid Dosage products manufacturing
- The role holder will have an 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 analyze process related data to determine 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 regarding critical issues related to product manufacturing and process validation where appropriate.
- Strong communication and negotiation skills 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 science, engineering or related field
- A minimum of five (5) years relevant experience
- Proven record in pharmaceutical technology - pharmaceutical process scale-up, technical transfer and manufacturing/packaging/artwork support/activities
Travel: This position requires up to 20% travel
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:New Brunswick - NJ - US: $96,360 - $116,761
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
