- • Executes the development and qualification of analytical methods for the biologics drug product development with an emphasis on Cell Based Potency Assay, ELISAs, SIMOA, SMCxPRO (Singulex Erenna) immunoassay, qPCR, ddCR, SDS-PAGE, and Western Blot.
• Creates written procedures and protocols.
• Responsible for creating detailed project plans including scientific strategy. Actively involved in the planning, execution and management of experimental studies.
• Organizes, schedules and participates in project team meetings to define and schedule project activities and review completed tasks.
• Communicates project status to supervisor, and/or project team leader.
• Writes, reviews and issues technical reports, technical memoranda and other documents for internal and external distribution.
• Hands-on experience in a developing immunoassays with a proven record of success in conducting R&D projects.
• Experience in method qualification, method transfer, and validation.
• Must have a thorough working knowledge of a wide range of analytical methods (i.e Cell Based Assay, Cell Culture, Singulex Erenna, SMCxPRO, Luminex, ELISA, MSD, qPCR, ddCR, SDS-PAGE, and Western Blot).
• Ability to independently develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems.
• Previous experience with development of biologics is a plus.
• Strong ability to evaluate and interpret analytical results and lead investigations to resolve analytical issues is required.
• Proficient in writing technical reports, protocols, and procedures.
• Strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to detail are essential skills for this position.
* This position requires individual to work with, and/or supervise staff handling of potent neurotoxins and in process samples that may contain toxin-expressing organism (Select Agents). Access to, and use of, select agents is covered by Federal policies
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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