Bristol Myers Squibb Team Lead - Sample Logistics in Devens, Massachusetts
Trains and mentors staff, occasionally performs sample receipt and processing of raw materials, in-process, stability, bulk drug substance (BDS) and drug product (DP) samples.
Performs testing on BDS and DP samples including, but not limited to appearance testing, reconstitution time and weight variation
Revises and writes procedures for managerial review and approval
Performs and/or provides subject matter expertise in root cause investigations for sample logistics.
Reviews/approves test data obtained for compliance to specification and reports abnormalities.
Leads the coordination and communication of samples to 2nd and 3rd parties as well as contract laboratories
Coordinates interdepartmental activities, providing technical expertise to ensure that the programs are in compliance with current industry standards.
Coordinates and collaborates with internal and external customers in order to support testing in Devens-QC
Reconciles and orders critical reagent inventory.
Logs in nonroutine LIMS jobs to support validation, investigation, qualification of sample
Participates on a variety of teams in support of business improvement projects.
Collaborates with management on the development and reporting of KPIs and metrics in the department
Drives and promotes continuous improvement projects
Leads the implementing OPEX initiatives the Sample Logistical area, including implementation of Lean labs Supports the implementation of Lean Labs
Bachelor’s Degree required with knowledge of GMP requirements.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Must have strong organizational skills and the ability to work as part of a team.
Must have strong communication skills and experience working cross-functionally and across sites within GPS.
Proficient in common computer software applications, experience with LIMS and LES computer applications a plus.
Practical experience with health authority inspections is preferred.
Minimum of 4 years experience in a related biopharmaceutical GLP or GMP laboratory preferred.
Lean methodology – including those obtained through yellow and green belt trainings is preferred.
Direct daily interaction with all staff and management of QC. Regular interaction with all departments within the facility and with other BMS sites as required to support assigned work.
Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may include periodic night shift or weekend assignments.
May work on assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Exercises judgment within generally defined practices and policies in developing improved business processes. Coordinates with customers and technical experts on decisions and applies appropriate notification to management.
Work is performed under general direction. Independently determines and develops approach to solution. May receive assignments which have a partially defined process with the objective of driving it to completion.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.