Senior manager, QC Bioanalytical

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 and 2021.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

BMS Cruiserath Biologics is seeking to recruit on a fixed-term contract (12-months) Senior Manager, Quality Control (QC) Bioanalytical, reporting to the Quality Control Release Associate Director. This position has responsibility for the management of laboratory testing and associated activities in the Bioanalytical laboratory for commercial drug substance and drug product batches. They will also be responsible for the laboratory testing for Technical transfer campaigns in support of New Product Introduction (NPI).

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

Key Duties and Responsibilities:

• Management of the operation of the Bioanalytical laboratory, ensuring commercial drug substance and drug product testing deadlines are met.
• Support of the technical transfer campaigns from CMOs and internal sites in support of NPI campaigns, ensuring predefined timelines are met.
• Liaise with key stakeholders in BAMs and NQC to support analytical lifecycle changes, method updates and CMO transfers.
• Liaise with key stakeholders, BAMs, and site teams to support analytical method technical transfers and validations as required.
• Ensure investigations and deviations are completed in a timely and compliant manner and robust CAPAs are implemented.
• Maintain a high standard of GMP compliance in the laboratory.
• Coordinate and manage audit readiness, both internal and external (e.g. HPRA/ FDA), taking ownership of topics as appropriate during regulatory inspections
• Review and approval of trending data including the product APQRs, ensuring actions required to address trends are appropriately implemented.
• Responsible for the recruitment, development, and management of the QC Bioanalytical teams.
• Management of team performance, completion of performance evaluations, providing feedback, coaching, and training to the QC team.
• Provide first hand leadership and communication of business-critical information to the team through the tier board management system.
• Maintain a safe working environment within laboratories for both BMS staff and external vendors.
• Management and recognition of team performance against key quality, safety, cost, and delivery metrics
• Support of QC planning and scheduling activities as required.
• Supports the drive for digital solutions and optimisations in the QC laboratories.
• Leads and fosters an environment of continuous improvement e.g. standard work
• Supports the continuous development and implementation of a comprehensive training programme.

Qualifications, Knowledge and Skills Required:

• The successful candidate must possess a Bachelor/Masters in Science or Science related discipline and have a minimum of 6 years' experience in the Pharmaceutical Industry.
• Deep and demonstrated understanding and experience of the principles of GMP / GDP
• Experience with cell culture and cell-based assays will be advantageous.
• An accomplished people manager with the ability to motivate and develop departmental staff through effective feedback and coaching.
• The candidate will have proven success working well in a team environment, as well as proven management skills to manage a team of professionals through changing business needs.
• Experience with method transfers and validations is preferrable, as well as experience interacting with regulatory agencies.
• Knowledge of US and EMA GMP regulations and guidance.
• Demonstrated management, interpersonal, communication, and motivation skills.
• Demonstrated understanding of test methods and instrumentation associated with the testing of drug substance and drug product release testing.
• Planning and organizing skills are required to plan, execute, and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.
• The candidate will be change agile and will have proven decision-making ability.

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, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

#LI-Hybrid

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 adastaffingsupport@bms.com . 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.

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

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