Manager, Upstream Manufacturing Technical Lead

Posted:
10/3/2024, 5:05:32 AM

Location(s):
Leinster, Ireland

Experience Level(s):
Senior

Field(s):
IT & Security

Workplace Type:
Hybrid

Working with Us
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 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: careers.bms.com/working-with-us.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.  

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Upstream Technical Lead within the Manufacturing Operations group on fixed term contract. Reporting to the Shift Lead, the role will support the ongoing manufacturing operations within the facility, as well as qualification activities for new processes and equipment. This is a 24/7 and or 12/7 shift role.

Key Responsibilities

  • Deliver expert level technical support for upstream manufacturing-process unit operations including but not limited to aseptic operations in Inoculation labs using single use technologies and biosafety cabinets in the scale-up of mammalian cell cultures according to established standard operating procedures (SOP’s).
  • Deliver expert level technical support for Cell Culture process unit operations using a combination of Single Use Bioreactors, Stainless Steel Bioreactors (200L–15,000L scale), Centrifuges and Depth filtration skids according to established standard operating procedures (SOP’s).
  • Deliver expert level technical support for Media Preparation process unit operations using a combination of Single Use Mixers and Stainless-Steel Vessels (100- 10,000L scale) according to established standard operating procedures (SOP’s).
  • Deliver expert level technical support for Clean in Place & Steam in Place unit operations, Parts washers, Autoclaves, Analytical equipment, and Bench-Top equipment. (Cedex, Vi-cell, Microscopes, PH meters, Osmo Analyzer)
  • Technical author and approver for operating procedures & documentation for large-scale manufacturing
  • Deliver and oversee expertise in training, training content design combined with oversight and approval of Manufacturing Specialist’s on-the-job training and competency.
  • Driving Right-First-Time execution on shift & front-line support/resolution of manufacturing issues
  • Expertise in the use of process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e. SAP. Trackwise, Infinity, Maximo etc.)
  • Lead shift-based Safety & Quality Investigations and drive effective CAPA implementation.
  • Oversee real-time review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance team and provide support to QA audit readiness activities.
  • Driving and promoting Good Manufacturing Practices Good Documentation Practices and adherence with Standard Operating Procedures
  • Operating to and maintaining dynamic schedules - in a fast-paced production environment
  • Deputizing and managing a team of Bioprocess Associates when the Shift Lean is unavailable.
  • Facilitate and lead change control and project changes to operations in the MPCC manufacturing facility in collaboration with the Manufacturing Operations group, Technical Transfer Teams, Manufacturing Engineers & the Automation teams
  • Support & Lead NPI execution activities and non-routine protocol activities
  • Role model and support a culture of continuous improvement and operational excellence
  • Ownership and promotion of improvement projects for manufacturing work practices and a safe working environment by application of sound scientific, engineering and lean principles
  • Role model of the BMS behaviours and Safety culture
  • Lead functional area handovers including safety oversite, schedule adherence, GxP activities, procedural adherence, troubleshooting and housekeeping.

Qualifications & Experience

  • Min. 5 years working experience in a large-scale biopharmaceutical manufacturing facility (Media Preparation, Inoculation lab, Cell Culture and Harvest) with a level 7 or above in science or engineering.
  • The successful candidate will be a proven subject matter expert in relation to Upstream Biologics processes and have a proven ability to lead a team of Bioprocess Associates.
  • Expert with Delta V and MES or similar control and data acquisition systems would be required.
  • Automation experience should include an ability to troubleshoot and run technical queries and reports in support of investigations and Data Integrity
  • Manufacturing and automation expertise and demonstrated ability to work independently and as part of a team.
  • Demonstrated problem-solving ability and the ability to work proactively to achieve demanding schedules
  • High proficiency in communication and collaborating at a variety of levels and the ability to work in a cross-functional and fast-paced team environment
  • Working flexibly to react to changing business needs.
  • Proven ability to support the close-out of complex investigations and good GMP awareness.
  • Proven ability to operate, maintain and troubleshoot bench analytical equipment supporting manufacturing processes.
  • Ability to adapt to a changing environment and handle multiple priorities.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, life assurance and on-site gym

#LI-Onsite

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 Careers
With 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 [email protected]. Visit careers.bms.com/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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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

Bristol Myers Squibb

Website: https://bms.com/

Headquarter Location: New York, New York, United States

Employee Count: 10001+

Year Founded: 1887

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine