Senior Engineer, Process Tech Transfer

Bristol Myers Squibb • Devens, MA

4d • Onsite

About The Position

Challenging. 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. 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: careers.bms.com/working-with-us. Position Summary The Senior Engineer, Process Tech Transfer assures effective process technology transfer for products to be manufactured in this site, to resolve process issues, and to optimize process/facility efficiency. They provide mentoring to junior team members and plays key role in managing team deliverables and development.

Requirements

• B.S. in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 10 years relevant experience in the biopharmaceutical industry., or its equivalent.
• M.S., in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 8 years relevant experience in the biopharmaceutical industry, or its equivalent.
• PH.D., in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 4 years’ relevant experience in the biopharmaceutical industry, or its equivalent.
• Mastery of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
• Proven experience in successful execution and management of process technical transfer.
• Experience in the design, control and operation of biologics upstream and downstream unit operations.
• Strong Experience in investigating process deviations and developing issue resolving CAPAs.
• Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.
• Excellent verbal & written communications skills.
• Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams.

Responsibilities

• Leads/ manages the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.
• Provides mentoring to junior members of the process technology transfer group.
• Oversees and authors facility fit reports and schedule adherence to each aspect of the tech transfers.
• Provides direct interface as subject matter expert with health authority and internal audits.
• Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls
• Responsible for interacting with cross-functional teams to forecast and procure required raw materials.
• Leads continuous improvement projects
• Identifies and assists in the implementation of new technologies from Development into Operations.
• Leads cross functional risk assessments
• Responsible for process and equipment change controls.
• Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
• Provides technical oversight of SOPs required for manufacturing.
• Provides required technical guidance and approval for manufacturing batch records.
• Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
• Reviews and approves single-use consumable drawings required for the manufacturing facility.
• Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees