Process Development Engineer, Device and Packaging DevelopmentJob Type: Full-Time
Location: New Brunswick, NJ
Drug Product Development (DPD)Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS's internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you'll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.
Position Summary:The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Process Development Engineer to join our team and contribute to our success in meeting the needs of our business and our patients.
The Process Development Engineer, Device and Packaging Development is an individual contributor accountable for the following:
- Under the general guidance, the Process Development Engineer will contribute to the development of fill finish and device assembly processes for sterile drug products and drug-device combination products, supporting clinical introduction and commercial launch.
- Collaborate with Clinical and Commercial Manufacturing to develop robust fill-finish and device assembly processes for new products, from early device and combination product development through prototyping, scale up, clinical, and commercialization.
- Participate in design for manufacturing (DFM) activities and process assessments to identify fits/gaps for new products, recommend manufacturing-process strategy, and support manufacturing site selection activities as needed.
- Participate in Design Reviews to ensure design robustness and manufacturability.
- Support knowledge transfer into internal and external manufacturing sites (CMOs) - including component specifications, test methods, equipment specifications, vendor / equipment selection, vendor management, factory acceptance testing (FAT), and qualification - and assist in the development and execution of IQ/OQ/PQ as well as process validations for combination products in accordance with established regulations, corporate policies and procedures.
- Provide technical support to manufacturing sites in close partnership with Clinical and Commercial Manufacturing to sustain product and process robustness and improve equipment performance, productivity, and asset utilization, including ongoing process performance metrics where applicable.
- Support product or process improvement and optimization at internal and external sites utilizing Lean and Six Sigma methodologies and support process risk assessment activities to identify critical process parameters and develop control plans to mitigate risks.
- Evaluate post design transfer changes (component, product, process) for impact on the manufacturing process, documentation, and design control elements, working with the manufacturing site, R&D, and Quality to assess risk/impact based on Design History File and in accordance with Design Controls.
Qualifications:- Minimum Bachelor of Science/Engineering in Mechanical, Biomedical, Industrial Engineering, or relevant engineering discipline. Advanced Degree (MS/M Eng) preferred.
- Minimum 5 years' work experience in a regulated industry with a Bachelor's degree, 2+ years with an advanced degree.
- Process development and engineering experience in the Medical Device, sterile drug products, Pharmaceutical or Biotechnology industry, with experience in aseptic processing (including filling), device assembly, labeling, molded plastic components and automated inspection.
- Ability to travel domestically and internationally, up to 15%.
- Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus.
Demonstrated ability to:- Influence areas not under direct control to achieve objectives.
- Work in a matrix environment and effectively support internal & external manufacturers and suppliers.
- Apply disciplined process development methods aligned with design controls, technology transfer, and validation principles for device and combination products.
- Strong technical, analytical and skills, as well as strong mechanical aptitude.
- Apply strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
- Communicate effectively, including internal/external presentations to suppliers, sites, and Sr. Management.
Compensation Overview:New Brunswick - NJ - US: $96,290 - $116,678
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 in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
On-site ProtocolBMS 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.
