Associate Scientist, Analytical Development

The Associate Scientist, Analytical Development (AD) is a key contributor responsible for supporting the development and qualification of robust, fit-for-purpose analytical methods for Quality Control (QC). The Associate Scientist will provide analytical support and document all activities in laboratory notebooks and technical reports following Good Documentation Practices (GDP). Responsibilities Method Development & Optimization (30%): Under the guidance of AD management and scientists, execute experimental protocols for developing and optimizing novel analytical methods (e.g., HPLC, UPLC, CE-SDS, cIEF, UV/Vis, ELISA) for testing drug substances and drug products. Method Qualification (30%): Under the guidance of AD management and scientists, perform hands-on execution of qualification studies, including accuracy, precision, linearity, range, specificity, detection limit, and quantitation limit assessments. Documentation & Compliance (20%): Assist in authoring GxP-compliant technical reports and Standard Operating Procedures (SOPs). Maintain meticulous laboratory notebooks and electronic records and submit for review in a timely manner. Additional (20%): Order and receive reagents and labware, as needed. Maintain general and assay-specific inventory. Log and store all received samples and items. Track tasks, meetings, events, etc. in AD team weekly schedule and keep up to date. Fully operate all laboratory equipment necessary to complete responsibilities. Log all equipment usage in necessary locations. Coordinate with other groups for testing/equipment needs. Assist with the day-to-day maintenance of an orderly analytical laboratory. Perform a weekly laboratory walk-through: Update inventory list(s). Dispose of hazardous waste (bench tops, large bins, HPLC waste). Dispose of expired materials (wet and dry reagents). Wash/put away glassware. Clean/organize bench tops. Discard/create waste streams. Seek opportunities for personal and professional growth (conferences, webinars, trainings, etc.). Qualifications BS/BA degree in science or similar area with 2-4 years of lab experience. MS degree in science or similar area with 0-2 years of lab experience. 0-4 years’ experience in the Biotechnology/Pharmaceutical industry working with biological products. Experience with HPLC, ELISA, CE-SDS (CGE), cIEF, and standard analytical techniques is preferred but not required. The ability to think and solve problems creatively from a critical and analytical perspective. Meticulous documentation and strong writing skills. Strong interpersonal skills. Exceptional self-management skills, including taking initiative and time management. Strong attention to detail and thorough cleanliness/organization. Excellent written and oral communication skills. Ability to work both independently and as part of a team. Confidence to ask questions and take calculated risks. Compensation The expected base salary range for this position is $66,413 - $86,250. 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 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. #J-18808-Ljbffr Celldex