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Position Summary
Cruiserath Biologics is seeking to recruit a QC Scientist to join the QC Separations Laboratory team on a 14 month fixed-term contract. 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.
Key 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
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 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 analysts
Author, 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 and fosters an environment of continuous improvement.
Ensures all QC Separations related activities are completed in a safe and compliant manner
Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.
Qualifications & Experience
A degree in a science, engineering or related discipline is essential along with extensive experience of analytical Testing in the pharmaceutical industry
Extensive knowledge of US and EMA GMP regulations and guidance.
Experience in analytical method transfers would be advantageous
Experience in GMP and GLP guidelines
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.
Excellent technical writing skills and attention to detail are essential
Excellent 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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
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.
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 a supportive culture, promoting global participation 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 an 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.
Supporting People With Disabilities
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.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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R1601000 : QC Scientist, Separations
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