Senior Manager, Qc Planner

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 .

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

The Role

BMS Cruiserath Biologics is seeking to recruit for a Fixed term contract, Senior Manager, QC Planner, reporting to the QC Director. The QC Planner position is a senior individual contributor role within the QC Operations team. The successful candidate shall be responsible for managing the Planning Strategy and execution for the Cruiserath Drug Substance and Drug Product site facilities and the Global Biologics Laboratory.

Key Duties and Responsibilities:
Liaise with Supply Chain and Planning teams to create, maintain and communicate the QC testing schedule for the wider Global Biologics Network release testing
Liaise with onsite supply chain, schedulers, production and sample management to create, maintain and communicate the QC testing schedule for Cruiserath drug substance (DS), raw materials and environmental samples.
Liaise with onsite supply chain, schedulers, production and sample management to create, maintain and communicate the QC testing schedule for the new Cruiserath Drug Product (DP) Facility.
Work with the QC team leads to create weekly forecast of incoming routine and adhoc DS & DP lots which meet stakeholder needs and prioritize appropriately
Escalate any scheduling or prioritization issues as needed to ensure appropriate and timely mitigation
Maintain the QC Release dashboards to communicate DP release status to all stakeholders
Represent QC at the Drug Substance Disposition Huddles
Monitor and report on all QC metrics pertaining to testing such as TAT and RFT on a weekly and monthly basis
Create and maintain an S&OP business process for monthly monitoring of DP, DS and DP Tech Transfer volumes by liaising with the fill sites and Supply Chain Leads
Create and maintain a business process to ensure all requests for nonstandard work (including complaints, hold time exceedance, ship on test or expedites) are received, scheduled and communicated to the impacted QC teams.
Compile the list of related medias and Buffers for each Drug Substance lot, tracking completion of testing and documenting completion through memos issued to QA
Responsible for driving adherence to QC Turnaround times for Drug Substance and Drug Product Lots, through tracking fora on a weekly basis
Responsible for co-ordinating the issuance of all Drug Substance and Drug Product CoAs
Responsible for creating and maintaining a standard request process for adhoc testing requests and adhoc information requests et system
Responsible for Product Record Attainment tracking and adherence on a monthly basis
Responsible for creating and maintaining a robust capacity planning process
Responsible for preparing and submitting planning forecasts in support of budget planning

Qualifications, Knowledge and Skills Required:
Minimum of a BSc in Biochemistry or related discipline

Minimum of 5 years hands on experience in a GMP Laboratory Setting
Strong background in quality control and regulatory compliance of commercial biologics in an FDA regulated environment.
Knowledge of finished product manufacturing as well as analytical testing.
Be very familiar with US and EU cGMP regulations and guidance.
Experience with direct FDA, EMA, and Global HA interactions including face-to-face interactions and/or regulatory filings.
Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.
Excellent written and verbal communication skills and experience of working with teams and influencing decisions.
Have experience leading cross-functional teams and knowledge of applicable regulatory inspections is desirable

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
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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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. 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.

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