Senior Analytical Development Lab Lead

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 116,000 - 151,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an experienced leader to oversee equipment maintenance, troubleshooting, and laboratory activities ensuring compliance with cGMP and company policies.

You will supervise AD lab operations, manage inventory, IT issues, and equipment onboarding while driving efficiency and accuracy in data handling. The role requires 8–10+ years in Analytical Development, strong classifications in ELISA and chromatographic assays, and proficiency with several lab software

Qualifications

• 8–10+ years’ experience in Analytical Development, preferably in a senior or leadership role within Biotech/Pharma.
• Experience with ELISA, HPLC, UPLC, CE-SDS, cIEF, DSC, DSF, SEC-MALS, DLS, LC-MS for monoclonal antibodies.
• Experience with listed software tools (ChemStation, Softmax, Compass for iCE, SoloVPE, Astra, MassHunter, Biovia ELN) is preferred but not required.
• Strong problem-solving, critical thinking, and analytical writing skills.
• Excellent collaboration, communication, and ability to influence cross-functional teams.
• Demonstrated self-management, initiative, and time-management in fast-paced settings.
• Strong organizational skills and multi-project coordination.
• Ability to work independently and as part of a team; willingness to take calculated risks.

Responsibilities

• Review of solution preparation notebooks / ELNs.
• Review of development, qualification and characterization notebooks for accuracy and timeliness.
• Number confirmations to support data review.
• Review/approval of technical reports.
• Manage equipment service plan information and scheduling of service visits.
• Oversight of IT tickets / follow-up for software / equipment issues.
• AD lab supervision: inventory management, onboarding inventory software, Smartsheet usage; ensure freezer inventories.
• Oversee ordering and receipt of reagents, equipment and lab ware.
• Schedule lab equipment PM/installation and oversee related activities.
• Oversee completion of sample information-receipt binders and instrument logs.
• Identify and manage problems, propose solutions, and implement actions.
• Supervise laboratory investigations in a timely and compliant manner.
• Maintain current awareness of improvements in laboratory methods and systems.
• Ensure analysts are trained on new analyses and equipment.
• Propose ideas for improvement of methods and responsibilities.
• Own projects: ELN templates, equipment tracking tools, onboarding new software/technologies.

Skills

Analytical development leadership

ELISA

HPLC/UPLC/LC-MS

Documentation

Cross-functional collaboration

Problem solving

Self-management

Multi-project management

Education

Bachelor of Science in biology/related field

Master’s degree preferred

Tools

ChemStation

Softmax

Compass for iCE

SoloVPE

Astra

MassHunter

Biovia ELN

Job description

Celldex Therapeutics, Inc. is seeking an experienced leader to oversee equipment maintenance, troubleshooting, and laboratory activities ensuring compliance with cGMP and company policies.

You will supervise AD lab operations, manage inventory, IT issues, and equipment onboarding while driving efficiency and accuracy in data handling. The role requires 8–10+ years in Analytical Development, strong classifications in ELISA and chromatographic assays, and proficiency with several lab software