We are currently seeking qualified candidates for a Lab Manager position with the Analytical Chemistry segment of a leading multinational life sciences company. This is a permanent position that will be based out of the Greater Boston Area, Massachusetts, United States.
The extractables and leachables (E&L) lab manager is responsible for direct oversight of all E&L laboratory operations and personnel. Daily laboratory operations are focused primarily on performing routine and custom testing according to client-approved protocols which are designed to satisfy generally accepted industry expectations and regulatory requirements, and which are executed to meet best-in-class quality standards. The manager’s scope of responsibilities also includes supporting the development of technical lab staff with a wide range of technical skills and with varying depth of industry experience.
- Review and approve test protocols and reports
- Schedule testing to maximize capacity, equipment utilization and throughput
- Coordinate on-time completion of equipment/instrument calibration, qualification and maintenance activities according to laboratory procedures and plans
- Lead, support and/or approve laboratory investigations and CAPA activities related to deviations, complaints and audit observations
- Periodic evaluation of external suppliers
- Establish/Assign learning plans and monitor training completion status for staff
- Coordinate on-time periodically reviews of E&L SOPs
- Managing change to continuously improve cycle time, right first time and rerun rate key performance indicators
- Participate in world-wide harmonization projects, goals and initiatives among other Company laboratories
EDUCATION, SKILLS & EXPERIENCE
- BS/MS in Analytical, Organic or Polymer Chemistry
- Min 5+ years of experience working in a regulated/accredited laboratory (i.e. GMP/ISO) with 2 years supervising or leading a team.
- Previous laboratory experience with one or more of the following techniques; GCMS, LCMS, ICP-MS, HPLC and FTIR
- Previous experience with sample preparation techniques including solid phase and liquid-liquid extraction
- Ability to prioritize high visibility projects to meet aggressive timelines
- Accurately forecast spending and deliver within financial target
- Excellent interpersonal, presentation, listening and communication skills
- Working knowledge of USP standards and BPOG methodology
- Analytical expertise in GCMS, LCMS, ICP-MS, HPLC and FTIR techniques desired
- Experience using Trackwise desired
- Write and/or review laboratory equipment/software validation protocols and reports according to FDA CFR Part 11, EU Annex 1 and GAMP standards
- Lean & Six Sigma certification desired