Analytical Development Lab Manager

Celldex Therapeutics•Fall River, MA

8d•$116,156 - $150,852

About The Position

Responsible for overseeing equipment maintenance and troubleshooting as well as laboratory activities to assure effective, efficient, and compliant adherence to all company policies, procedures and when appropriate, cGMP requirements. Oversee the timely assignment and completion of work for the laboratory.

Requirements

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.

Nice To Haves

Master’s Degree preferred.
Experience with ChemStation, Softmax, Compass for iCE, SoloVPE, Astra, MassHunter and Biovia ELN preferred, but not required.

Responsibilities

Review of solution preparation notebooks / ELNs
Review of development, qualification and characterization notebook entries as per designated review responsibilities (based on experience) for accuracy and appropriate timeliness
Number confirmations to support data review
Review/approval of technical reports
Management of equipment service plan information and scheduling of service visits / interaction with technicians
Oversight of IT tickets / follow-up for software / equipment issues.
AD lab supervision – Inventory management, onboarding of inventory management software/use of Smartsheet
ensuring 2-8 and freezers (-20, -80) inventories kept current
proper disposal of samples no longer needed and hazardous waste streams
Oversee the ordering and receipt of reagents, equipment and lab ware.
lab equipment PM/installation scheduling, preparation and oversight
oversight of completion for sample information-receipt binders/ instrument logs.
Independently identify and /or manage actual and potential problems as they arise and propose solutions, implement actions to be taken and / or experimental designs to be executed.
Supervise laboratory investigations in a timely and compliant manner.
Maintain current awareness of and recommend implementations for improvements in accuracy and efficiency of laboratory functions, procedures and systems.
Ensure analysts are trained on and proficient in performing new analyses and operating new equipment.
Propose new ideas for improvement of laboratory methods, procedures and overall departmental responsibilities.
Willingness to take ownership of projects and commitment to see through to completion independently: ELN template generation, Equipment management tracking tools, Onboarding of new software and/or technologies