Scientist, MS&T Process Characterization Lab

Bristol Myers Squibb • New Brunswick, NJ

7d

About The Position

The Process Characterization Lab Scientist is a highly impactful and hands-on position within our global Parenteral Manufacturing Science & Technology organization, located in New Brunswick, NJ. The incumbent conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral/biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for late-stage to commercial and lifecycle products. The role touches many aspects of parenteral manufacturing including sterile filtration, formulation development/characterization, lyophilization, product compatibility and more. This gives the scientist the opportunity to contribute true scientific outcomes; enabling data driven decisions and scientifically sound manufacturing processes. This position is accountable for the design and execution of process characterization experiments to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations and providing specialized expertise, as necessary, to complement site capabilities for critical investigations or process improvements.

Requirements

• Bachelor’s degree with 5-7 years of relevant experience.
• Thorough hands-on experience in the laboratory and a broad understanding of sterile product (particularly biologics) formulation development, analytical methods commercial manufacturing unit operations
• Proficient in critical thinking, clear & concise technical writing (specifically in scientific study plans and reports) and verbal communication
• Ability to design and execute scientifically sound, hypothesis driven experiments
• Demonstrated ability to: Troubleshoot, interpret and discuss data with strong scientific arguments, draw appropriate conclusions and identify logical next steps
• Work independently under minimal supervision for most tasks
• Participate in troubleshooting of routine problems and initiatives related to continuous improvement and development of new approaches/technologies
• Lead activities with other team members to achieve results
• Communicate effectively with manager and cross-functional teams/stakeholders
• Make presentations in multidisciplinary meetings, logically present information to convey clear messages

Nice To Haves

• Master and Ph.D. is preferred but not required. Time spent in advanced degree program may consider as equivalent experience.
• Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS)
• Familiar knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals

Responsibilities

• Design and execution of robust experiments to support lifecycle management activities of commercial parenteral products including: process improvements, deviation investigation and technology transfer
• Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms
• Partner with Drug Product Development, Parenteral Launch and Sterile Capabilities, Process Engineering, manufacturing sites and Analytical colleagues in design and execution of experiments
• Apply scientific and/or technical skills and functional knowledge to complete laboratory work and data analysis/interpretation
• Drive scientific innovation and new approaches in the lab, through research in literature, internal/external forums and/or trainings
• Maintain complete and accurate laboratory notebook and protocol/report documentation by following applicable SOP and Policy requirements
• Effectively represent the Process Characterization Lab in various internal and external teams to present experimental plans, review results and provide technical recommendations
• Lead laboratory maintenance through tracking instrument calibration, maintaining stock of supplies, general lab cleanliness and organization
• Lead lab safety initiatives, inspections and training
• Support mentorship of others within group/team; train others on procedures

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level