Analytical Development Lab Manager

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

Benefits offered by this job

Health insurance

401(k) plan

Paid holidays

Job summary

Celldex Therapeutics, Inc. seeks an experienced leader to oversee analytical development and laboratory operations, ensuring compliant maintenance, data integrity, and timely completion of work.

You will coordinate equipment service, IT ticket follow-up, and supervise lab investigations while driving improvements in efficiency and accuracy. The role requires a strong background in biotech analytics, leadership experience, and hands-on proficiency with ELN systems and standard assay platforms.

Qualifications

• BS in biology/biotechnology or related field; MS preferred.
• 8–10+ years in Analytical Development, senior/leadership role in biotech/pharma.
• Experience with ELISA, HPLC, UPLC, CE-SDS, cIEF, DSC, DSF, SEC-MALS, DLS, LC-MS for monoclonals.
• Experience with ChemStation, Softmax, Compass for iCE, SoloVPE, MassHunter, Biovia ELN preferred.

Responsibilities

• Oversee equipment maintenance and troubleshooting and lab activities to ensure compliance with company policies and cGMP where applicable.
• Review notebooks/ELNs for solution preparation and development/qualification entries.
• Manage service plans and scheduling for lab equipment and coordinate with technicians.
• Oversee IT tickets and software/equipment issue resolution; ensure proper inventory and onboarding of software.
• Lead ELN template generation, equipment tracking tools, and onboarding of new technologies.

Skills

Analytical Development Leadership

Problem Solving

Documentation

Team Collaboration

Time Management

Education

Bachelor of Science in Biology/Biotechnology or related field

Master’s degree preferred

Tools

ChemStation

Softmax

Compass for iCE

SoloVPE

MassHunter

Biovia ELN

Job description

Overview

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.

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

Qualifications

• Bachelor of Science degree in biology, biotechnology, or related science field. Master’s Degree preferred.
• 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.
• Experience with ChemStation, Softmax, Compass for iCE, SoloVPE, Astra, MassHunter and Biovia ELN preferred, but not required.
• The ability to think and solve problems creatively from a critical and analytical perspectiveformethods, instrumentation, and unexpected results.
• Meticulous documentation and strong writing skills.
• Strong interpersonal skills, includingexcellent 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.

Compensation Statement

The expected base salary for this position is: $116156.00 to $150852.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.