Senior Specialist, QC New Product Introduction & Investigations

Conteúdo do emprego

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.Position SummaryIn this role you will lead QC Deviations and Laboratory investigations assuring completion on time and in compliance with internal procedures. You will perform formal root cause analysis, define effective corrective and preventive actions. This position will work cross-functionally to support new product introduction into the Quality Control Laboratory and assessment of trial material. The position will report to Sr. Manager QC New Product Introduction & Investigations.Key ResponsibilitiesDeviations and Investigations Management Support

• Act as Deviation Owner and/or Lead Investigator for QC deviations/investigations requiring a formal root cause analysis.
• Work cross-functionally with impacted areas to define appropriate and effective corrective and preventive actions.
• Ensure timely and compliant closure of QC deviations/investigations and CAPAs to Bristol Myers Squibb procedures.
• Escalate issues requiring management decision in a timely manner.
• Provide appropriate level of reporting and communication on the assigned deviation/ investigations at Quality governance forums.
• Present deviations in audits conducted by regulatory agency representatives.
• Authors, reviews, and approves complex GMP documentation such as standard procedures, work practices, training plans, and reports as result of deviation/investigation.

Perform Trial material assessment

• Work collaboratively with QC Incoming Material, QC Commercial Drug Product and other cross-functional teams on testing requirements and sampling plans.
• Coordinate and/or perform testing of Trial material.
• Participate in cross functional teams meeting and provide trial material assessment QC progress.
• Assist management with scheduling testing and setting priorities of self and others.
• Act as a team leader to ensure work is performed according to schedule.
• Assist with allocation of resources, such as instrumentation and analyst availability.
• Assist analysts with questions and troubleshooting.
• Communicate effectively with management regarding complex issues.
• Point of contact in supervisor’s absence.
• Support testing of raw material, in-process, finished product samples in support of transfer/qualification.
• Perform various wet chemistry and analytical chemistry methods.
• Execute protocols, methods, and procedures with adherence to cGMP documentation requirements.
• Complete all work assigned in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• Train QC personnel on new methods transferred.
• Support with new equipment installation related activities.
• Support reference standards management.
• Support QC raw materials, drug product, and stability samples testing teams as required.
• Work collaboratively with QC teams on release samples testing as needed.
• Provide technical support to QC team members.
• Assists with review, verification, and approval of data.
• Serves as technical reviewer of appropriate departmental procedures.
• Reviews and approves documentation as required by laboratory procedures.
• Performs peer review as needed.
• Performs verification of software templates and custom fields as required.
• Promotes safe practices and behaviors.
• Reports immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future.
• Demonstrate Bristol Myers Squibb values.
• Performs other tasks as assigned.

Qualifications & ExperienceEducation and Experience

• BSc degree in Life Sciences, Chemistry, or Federal Certificate of Capacity as Laboratory Technician or similar education.
• Minimum 6 years of work experience in a GMP environment or regulated industry.
• An equivalent combination of education and experience may substitute.
• Hands on experience with various analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).
• Extensive knowledge on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.

Required Competencies: Knowledge, Skills, and Abilities

• Knowledge of analytical method transfer and analytical method validation.
• Knowledge of Data Integrity and Good Documentation Practices.
• Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements.
• Exceptional technical writing skills.
• Work to improve efficiencies through process improvements
• Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to perform job duties.
• Detailed oriented, and flexible.
• Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities.
• Understand how to collaborate and communicate effectively with a variety of different people and roles.
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Fluent in English or French and professional command of the second language (written and verbal)

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.