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Principal Scientist - Technology Transfer & New Technologies

Company: Disability Solutions
Location: New Brunswick
Posted on: July 2, 2024

Job Description:

Working with UsChallenging. 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 rich in diversity. 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: .Position SummaryThe Principal Process Engineer/Scientist acts as a technology transfer lead in the parenteral manufacturing MS&T group. This position is accountable for the technical interface between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle parenteral products. This position is the principle subject matter expert and process owner for the end-to-end manufacturing process for liquids and lyophilized parenteral products at Bristol Myers Squibb. Ensures processes are designed and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. This position will also work on new technology initiatives for the sterile network, including evaluation and testing to verify the technology is suitable for sterile processing applications. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech transfer business processes. This position will report into the Senior Director of Manufacturing Science and Technology, Parenteral MS&T and is located in either New Brunswick, New Jersey USA, or Dublin, Ireland.Key Responsibilities

  • Leads parenteral technology transfer projects for either key lifecycle biologic parenteral products or products in the late stage pipeline intended for commercialization, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
  • Development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
  • Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
  • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes.
  • Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage. Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from 'sending' sites for an optimized manufacturing process.
  • Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
  • Evaluates new technology through a combination of industry benchmarking, equipment vendor interactions, generation/execution of technical protocols and/or other means to verify the technology is suitable for either sterile processing application and/or downstream processing steps in a sterile operation. Works in conjunction with internal manufacturing sites and key stakeholders to evaluate new technology and advance towards establishing it within the DP mfg network.
  • Leads, motivates, mentors, and develops team members to meet and exceed plant and company goals and objectives.
  • Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities and establishes strong working relationships with the BMS internal manufacturing sites.
  • Responsible to review and co-author key CMC sections.
  • Requires approximately -20% travel.Qualifications
    • Bachelor's degree in Pharmacy, Biochemistry, Engineering or related Pharmaceutical sciences.
    • Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry.
    • Three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes. Experience
      • Subject matter expert in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology, lyophilization, pre-filled syringe operations. Strong knowledge of global regulatory requirements related to the design and control of these processes.
      • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.
      • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes and evaluation/testing and selection of new technologies.
      • Strong background/experience with lyophilization preferred.
      • Strong oral and written communication skills.
      • Ability to work within and lead cross-functional technical teams.
      • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
      • Strong understanding of project management systems and tools is preferred.
      • Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
      • Ability to work in a fast paced, complex and changing environment.
      • Excellent analytical, technical and strategic thinking skills and experiences.
      • Demonstrated management, interpersonal and teamwork skills. 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. Uniquely Interesting Work, Life-changing CareersWith 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 an inclusive culture, promoting diversity 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 a diverse 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 . Visit 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, New Brunswick , Principal Scientist - Technology Transfer & New Technologies, IT / Software / Systems , New Brunswick, New Jersey

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