Cruiserath, IE
21 hours ago
Manager, QC Separations Technical Lead

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

Cruiserath Biologics is seeking to recruit on a fix-term contract, a Manager, QC Separations Technical Lead to join the QC Separations Laboratory team. Reporting to the Senior Manager, QC Separations they will manage analytical method transfers, validations and verifications, provide technical guidance to QC Separations laboratory analysts and coordinate training efforts for method transfer. The candidate must have a strong understanding of the needs of a routine biopharmaceutical drug product/drug substance release laboratory.

They will also provide technical leadership and guidance to the QC Separations team on the establishment of the laboratory procedures and practices, quality system elements, equipment qualifications, and day to day troubleshooting of analytical issues.

Technical expertise should include some of the following Biopharmaceutical analytical techniques: Size Exclusion Chromatography, Charged Aerosol detection, HIAC, Appearance, SDS-PAGE and peptide mapping. Experience with the following instrumentation and software would be an advantage: HPLC, UPLC and Empower.

NOTE: This is not people manager role.

Key Duties and Responsibilities:

Oversee analytical method transfers and manage investigations associated with the method transfers ensuring on time deliveryCo-ordinate local activities for multi-site analytical method co-validationsReview of corporate policies/directives and pharmacopoeia for laboratory complianceEstablish communication channels between all stakeholders to ensure visibility on end-to-end processTroubleshooting of complex analytical and instrumentation issuesMonitor method, product trends and pro-actively address changes and anomaliesRepresent the QC Separations function during audits on all technical topics including but not limited to out of specification investigations, method and product trends, method transfers etc.Maintain oversight of and coordinate training efforts to ensure training numbers are sufficient to meet testing requirements.Support the development and coaching of testing analystsAuthor, review and approve test method, reports, risk assessments, SOPs.Provide SME expertise, review and approval of deviations, lab investigations, change control, CAPA etc.Review and approve technical documents for regulatory agency submissions and author responses to agency questions as required.Leads efforts to ensure that the sterility team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.Leads and fosters an environment of continuous improvement.Ensures all QC Separations related activities are completed in a safe and compliant mannerBuilds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.

Qualifications, Knowledge and Skills Required:

A degree in a science, engineering or related discipline is essential along with extensive experience of Sterility Testing in the pharmaceutical industryExtensive knowledge of US and EMA GMP regulations and guidance.Experience in analytical method transfers would be advantageousExperience in GMP and GLP guidelinesPlanning 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.Excellent technical writing skills and attention to detail are essentialExcellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

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.

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.

Confirm your E-mail: Send Email