CHEManager International · 11 hours ago
Scientist 1 - Product Characterization
Rockville, MD
Full-time
Onsite
Entry, Mid Level
$72K/yr - $132K/yr
1+ years expCHEManager International is seeking a Scientist 1 for their Product Characterization Laboratory within the Biologics department. The role involves acting as a subject matter expert in bioassay development and overseeing safety testing for clinical and commercial products while ensuring compliance with regulatory requirements.
Newspapers
Responsibilities
Performs testing in accordance with SOPs and regulations (cGMP and GLP)
Act as subject matter expert (SME) for specific defined area(s) of the business
Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems
Independently applies basic scientific principles in the design of experiments and the development of assays
For GLP studies, acts as Study Director
Maintains complete and comprehensive records for study integrity
Makes detailed observations, documents result and performs data analysis
Operates and maintains lab equipment as required by SOPs and testing procedures
Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.)
Utilizes problem solving/ trouble shooting skills
Communicates deviations/ events, progress and interim results to Study Management
Leads the completion of event records
Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing
Maintains a working knowledge of lab procedures and assays
Creates/ revises SOPs, laboratory records and other related documentation as assigned
Writes technical reports for internal use and collaborates on papers for external use
Performs training of laboratory personnel as needed/ assigned
Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment
Acts as key driver/ champion on project teams
Complies with company health and safety regulations and procedures
Qualification
Required
Ph.D. in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc.) with 1+ years of experience in a laboratory environment - OR -
Master's degree in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc.) with 3+ years of experience in a laboratory environment - OR -
Bachelor's degree in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc.) with 5+ years of experience in a laboratory environment
Performs testing in accordance with SOPs and regulations (cGMP and GLP)
Act as subject matter expert (SME) for specific defined area(s) of the business
Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems
Independently applies basic scientific principles in the design of experiments and the development of assays
For GLP studies, acts as Study Director
Maintains complete and comprehensive records for study integrity
Makes detailed observations, documents result and performs data analysis
Operates and maintains lab equipment as required by SOPs and testing procedures
Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.)
Utilizes problem solving/ trouble shooting skills
Communicates deviations/ events, progress and interim results to Study Management
Leads the completion of event records
Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing
Maintains a working knowledge of lab procedures and assays
Creates/ revises SOPs, laboratory records and other related documentation as assigned
Writes technical reports for internal use and collaborates on papers for external use
Performs training of laboratory personnel as needed/ assigned
Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment
Acts as key driver/ champion on project teams
Complies with company health and safety regulations and procedures
Preferred
Experience with some or all of the following technical disciplines
Flow Cytometry (potency, titer, viability or identity)
Molecular qPCR and/or ddPCR
Cell-based Immunoassays
Quantitative ELISA
Experience with industry GxP compliance
Intermediate skills in applicable computer programs (Softmax, PLA, or FACSDiva)
Excellent verbal and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc
Excellent time management skills
Highly collaborative as well as independent
Demonstrates a high level of initiative and leadership capabilities
Effective coaching and training skills for complex and highly technical work
Highly, technically competent
Benefits
Medical, vision, and dental insurance
Life insurance
Disability insurance
A 401(k) matching program
Paid time off
Paid holidays
Short-term or long-term incentive compensation, including, but not limited to, cash bonuses
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase