Manufacturing Tech Lead - Night Shift

Bristol Myers Squibb; Harvard (MA); On-site; USD 55,000 - 67,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Health benefits

Job summary

Bristol Myers Squibb is seeking a Technical Lead for the night shift to act as the technical expert in executing commercial manufacturing processes for therapeutic proteins under cGMP. You will monitor real time operations, drive process improvements, and coordinate with project leads and manufacturing technology teams to ensure right-first-time results.

The role requires deep GMP knowledge, a BS degree in a sciences field, and a track record of managing complex manufacturing tasks in a

Qualifications

• B.S. in science, engineering, biochemistry or related discipline; highly desired.
• Minimum 5+ years process operations experience in a highly automated biotech manufacturing facility under GMP.
• Regulatory knowledge of GMP and SOPs; strong technical/operational knowledge of upstream or downstream unit operations.
• Proven ability to solve complex technical issues in biologics manufacturing.

Responsibilities

• Lead routine and complex manufacturing assignments with initiative and problem solving.
• Coordinate change controls and communicate operational variances.
• Act as acting Shift Supervisor/Manager in their absence; direct work and manage personnel matters.
• Perform real time process monitoring and drive key decisions with the team.
• Support process technology improvements and tech transfer collaborations.

Skills

5+ years GMP operations

Biologics manufacturing

SOPs knowledge

Regulatory compliance

Education

B.S. in science/engineering/biochemistry

Tools

DeltaV

Syncade Interactions

Pi Vision

SAP

Infinity

Maximo

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Summary

The Technical Lead is the shift's technical expert in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).

Shift 5PM - 5AM rotating 3-2-2

MAJOR DUTIES AND RESONSIBILITIES

• Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. – striving for right first time through adherence of GMP activities.
• Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation. Communicate and resolve operational variances.
• Serve as the “acting” Shift Supervisor/Manager in absence of Shift Supervisor/Manager – Coordinate, direct and oversee work execution and manage personnel related issues.
• Executes real time process monitoring – including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions.
• Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
• Participate in performance review discussion. Leads routine investigations in Infinity as a low-level lead investigator – drives technical issues working with cross functional team members. Support complex investigations and CAPAs – author, review, approval, in case of excess investigation beyond planned capacity.
• Actively involved in safety related GEMBA, safety 4-box and safe IM investigation.
• Actively involved in coaching of team members to prevent human related error and quality events.
• Supports issue escalation with key stakeholders, troubleshooting systems and equipment issues, and working collectively to drive resolution.
• Support real time process reports review and resolve open issues.
• Trend issues and strives to right first time.
• Execute and drive continuous improvements such as procedure updates in electronic document repository (DCA)
• Supports Tech transfer team through active participation in ensuring that new process can fit and executes in a sustainable manner.
• Assigned area owner – drive facility upkeep through escalation of service requests, area walkthroughs, safety escalations (SAFE IM) and generation of safety communications.
• Adheres to Good Manufacturing Practices and standard operating procedures. Weighs and checks raw materials.
• Assembles, cleans, and sterilizes process equipment, monitors processes.
• Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
• Operates and trains others all production equipment within the assigned functional area (i.e. Upstream Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment or Downstream Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.).
• Regularly provides training and operational guidance to staff. Effectively uses process automation systems (i.e., Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e., SAP, Infinity, Maximo etc.).
• Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
• Support mentoring and coaching of operators on safety, executing task with a quality mindset, and prioritizing daily task to drive schedule adherence.
• Assists with the coordination and implementation of special projects such as validation, complex investigations, and protocol execution.

KNOWLEDGE AND SKILL

• B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• A minimum of 5+ year’s process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
• Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
• Demonstrated experience in solving complex technical issues in biologics manufacturing.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• Previous work experience where attention to detail and personal accountability were critical to success.
• Demonstrates good interpersonal skills, is attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.

Compensation Overview

Devens - MA - US $40.05 - $48.53per hour

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https //careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606971 Manufacturing Tech Lead - Night Shift