Manager, Tech Transfer Lead

Bristol Myers Squibb•Devens, MA

1d•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 Manager, Tech Transfer Lead assures effective process technology transfer for products to be manufactured in this site, to resolve process issues, and to optimize process/facility efficiency.

Requirements

B.S. in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 6 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 4 years relevant experience in the biopharmaceutical industry., or its equivalent.
PH.D., in biological sciences or chemical/biochemical engineering, or related discipline.
Mastery of SOPs, cGMPs and the know how to work within a regulatory environment.
Proven experience in successful execution and management of process technical transfer.
Experience in the design, control and operation of biologics unit operations (upstream or downstream).
Strong Experience in investigating process deviations and developing issue resolving CAPAs.
Experience 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.
Engineers perform work in a business office area and are also required to work within the manufacturing facility where industrial manufacturing setting hazards are present, and PPE is required.

Responsibilities

Leads the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.
Authors facility fit reports and schedule adherence to each aspect of the tech transfer.
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.
Support of health authority and internal audits
Identifies and assists in the implementation of new technologies from Development into Operations.
Leads continuous improvement projects
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 required technical guidance for SOP’s required for manufacturing.
Provides the required technical guidance and approval for manufacturing paper and electronic batch records.
Compiles data from manufacturing, performs statistical analysis to trend and track process performance, and 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.
Will work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Decision making is aligned with line management prior to final decision incorporation.
Ability to make decisions required to keep assignments moving toward completion and understanding when to escalate concerns to remove roadblocks.

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.

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