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Manager, Senior Engineer I
Posted on 7/29/2022
INACTIVE
Locations
United States
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
Marketing
Writing
Requirements
  • B.S. with 6-8 years of experience or M.S. with 4-6 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent
  • Subject matter expert of raw materials (both liquid and single use system)
  • Strong knowledge of lentiviral vector in CAR-T cellular therapy
  • Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing
  • Experience working with vendors and contract manufacturing sites
  • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs
  • Ability to assess risk and develop contingency plans for process risks
  • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities
  • Detail oriented with excellent verbal and written communication skills
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations
  • Experience with Quality Management System (Ex. Deviation, CAPA, Change Management)
  • Knowledge of GMP manufacturing practices and documentation requirements
  • Technical experience working with raw material suppliers for biopharmaceutical or cell therapy manufacturing, including collaborative engagement on investigations, technical diligence, and strategic initiatives
  • Experience writing and/or supporting protocols and testing for Extractables and Leachables (E&L) studies
  • Previous experience with raw material supplier selection, supplier relationship management and performing technical diligence visits and/or quality audits
  • Understanding of key considerations for single-use containers used for raw materials
  • Familiarity with raw material supply chains and manufacturing methods
  • Experience with commercial product support, i.e., post-marketing commitments
  • Contributions to industry consortia (e.g., BPOG) to drive establishment and improvement of industry best practices and standards for raw material development and management
  • Lean Manufacturing experience is desired
Responsibilities
  • Serve as a SME for raw materials including single-use systems (SUS) and material sciences
  • Provide technical support on in CAR-T commercial manufacturing
  • Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications
  • Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials
  • Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes
  • Vendor management including change controls, audits, deviations, and QRM programs
  • Support investigations and ensure compliance with internal standards and requirements
  • Perform technical diligence visits to raw material supplier sites with cross-functional teams
  • Provide necessary technical analysis to support impact assessments and investigations
  • Author responses for Information Request (IR) from regulatory bodies
  • Provide mentorship or management of junior member(s) of the team
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.