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Analytical Development Lab Manager

$116.16k - $150.85k

Celldex Therapeutics, Inc.

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 / ELNsReview of development, qualification and characterization notebook entries as per designated review responsibilities (based on experience) for accuracy and appropriate timelinessNumber confirmations to support data reviewReview/approval of technical reportsManagement of equipment service plan information and scheduling of service visits / interaction with techniciansOversight of IT tickets / follow-up for software / equipment issues.AD lab supervision –Inventory management, onboarding of inventory management software/use of Smartsheetensuring 2-8 and freezers (-20, -80) inventories kept currentproper disposal of samples no longer needed and hazardous waste streamsOversee the ordering and receipt of reagents, equipment and lab ware.lab equipment PM/installation scheduling, preparation and oversightoversight 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 generationEquipment management tracking toolsOnboarding 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 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. 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. Compensation for this role 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 pageCelldex 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. Job Summary

Vacancy posted 2 hours ago
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