Orange County Metro Area, CA
Main Areas Of Responsibilities:
- Executes the development and qualification of analytical methods for the biologics drug product development with an emphasis on SMCxPRO (Singulex Erenna) immunoassay.
- 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.
- Experience in a developing immunoassay with a proven record of success in conducting R&D projects.
- Must have a thorough working knowledge of a wide range of analytical methods (i.e Singulex Erenna, SMCxPRO, Luminex, ELISA, MSD).
- Ability to independently develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems.
- Previous experience with biologics and/ or hydrogels 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.
- Working knowledge in analytical development
- Must be knowledgeable using statistical programs for analytical data evaluation.
- Ability to critically review and evaluate analytical data and make conclusions/recommendations based on data.
- Must possess good interpersonal skills, the ability to work in a dynamic team environment and must multi-task to meet project timelines.
- Ph.D. and 2+ years of industry experience or Master s degree and 4+ years of industry experience. Degree in a related scientific or engineering discipline (cell biology, molecular biology, immunology or similar).