Engineer, CTTO DP Labs

Bristol Myers Squibb • Summit, NJ

3d • Onsite

About The Position

The Process Engineer in Cell Therapy Technical Operations will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the BMS cell therapy GMP manufacturing facilities. The engineer will be part of a team tasked with determining the root cause of manufacturing investigations. This individual will be expected to lead, design and execute experiments, evaluate data, and draft technical reports in support of improvements, investigations, and manufacturing process changes. The Process Engineer will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes. The Process Engineer will also partner with cross functional groups and function as Subject Matter Expert (SME) on processes, equipment, and compliance issues in manufacturing.

Requirements

• Degree in Biological Sciences, Chemical Engineering, Life Sciences, or related discipline.
• BS degree with minimum of 6+ years of relevant experience, or MS degree with minimum 4+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
• Leadership experience with managing teams and direct reports
• Excellent documentation skills and diligence with cGMP experience a plus.
• Ability to effectively lead and work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent critical thinking skills.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing with excellent oral communication skills.

Nice To Haves

• Experience with cell therapy process development or manufacturing
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• Experience executing investigations in support of commercial manufacturing
• Experience with commercial product support, i.e., post-marketing commitments, on-going validation, and comparability
• Combination of experience in process development, Global MS&T, Site MS&T, and quality.
• Operational excellence training/background

Responsibilities

• Lead, support, design, and execute experiments in the CTTO DP & Vector labs which includes aseptic processing and operation of automated process equipment.
• Partner with cross functional groups and teams and demonstrate leadership skills interacting with them.
• Manage and oversee junior engineers on performance, studies, and review technical reports and investigations.
• Summarize experimental data and aid in analysis to draw conclusions.
• Lead or participate in Root Cause Analyses (RCA) to determine cause of manufacturing process investigations.
• Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.
• Lead or Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Lead, develop, and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.
• Lead or support process comparability and process validation studies including planning, execution, and documentation management.
• Support necessary technical experiments and analysis to enable decisions related to raw materials changes.
• Contributes to ownership and advancement of work processes, and procedures.

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• 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.

What This Job Offers

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