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Manager, QC Separations Technical Lead

4 months ago

County Dublin, Ireland Bristol Myers Squibb Full time
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 IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business unitsLocated 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.The RoleBMS Cruiserath Biologics is seeking to recruit on a fixed-term (12 months) contract, Manager, QC Separations Technical Lead to join the QC Separations Laboratory team. Reporting to the QC Separations Senior Manager, they will manage analytical method transfers, validations and verifications, provide technical guidance to QC Separations laboratory analysts and coordinate training efforts for method transfer and routine assay execution. 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.Key Duties and Responsibilities:
  • Oversee analytical method transfers and manage investigations associated with the method transfers ensuring on time delivery
  • Co-ordinate local activities for multi-site analytical method co-validations
  • Review of corporate policies/directives and pharmacopoeia for laboratory compliance
  • Lead laboratory investigations to ensure timely close-out
  • Establish communication channels between all stakeholders to ensure visibility on end-to-end process
  • Troubleshooting of complex analytical and instrumentation issues
  • Monitor method, product trends and pro-actively address changes and anomalies
  • Represent the QC Separations function at inspections 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.
Qualifications, Knowledge and Skills Required:
  • A minimum of a third level qualification (Degree) in Biochemistry or related discipline
  • 5 years hands on experience in a GMP laboratory setting. Previous experience in analytical method transfers would be advantageous
  • The successful candidate must demonstrate a proven ability to work independently and autonomously
  • The successful candidate must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines
  • The successful candidate must demonstrate excellent time management and organisational skills
  • Excellent technical writing skills and attention to detail are essential
  • Excellent written and verbal communication and the ability to contribute to and lead in a team based collaborative environment are essential.
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