Analytical Development Lab Manager
$116,156–$150,852 year
On-siteFall River, Massachusetts, United States
Job Summary
Oversee equipment maintenance, troubleshooting, and laboratory activities to ensure compliance with cGMP policies and procedures. Manage the timely assignment and completion of work, including reviewing solution preparation notebooks, technical reports, and development qualification entries for accuracy. Direct inventory management for 2-8 and freezer storage, oversee reagent ordering, and schedule equipment preventive maintenance and service visits. Supervise laboratory investigations, ensure analyst training on new analyses and equipment, and independently identify problems to propose solutions and experimental designs. Maintain awareness of laboratory functions to recommend improvements in accuracy and efficiency while managing IT tickets for software and equipment issues.
Required Qualifications
- Bachelor of Science degree in biology, biotechnology, or related science field
- 8 - 10+ years' experience in Analytical Development preferably in a senior or leadership position in the Biotech/Pharma industry or equivalent combination of education and experience
- Experience with ELISA, HPLC, UPLC, CE-SDS, cIEF, DSC, DSF, SEC-MALS, DLS, LC-MS in testing monoclonal antibodies
- The ability to think and solve problems creatively from a critical and analytical perspective for methods, instrumentation, and unexpected results
- Meticulous documentation and strong writing skills
- Strong interpersonal skills, including excellent communication, collaboration, and the ability to influence cross-functional teams
- Exceptional self-management skills, including taking initiative and time management
- Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously in a fast-paced environment
- Ability to work both independently and as part of a team
- Confidence to ask questions and take calculated risks
Desired Qualifications
- Master's Degree preferred
- Experience with ChemStation, Softmax, Compass for iCE, SoloVPE, Astra, MassHunter and Biovia ELN preferred, but not required
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