Senior Scientist

Independently perform lab operations for developing and manufacturing reagents, ensuring compliance with quality and regulatory standards through commercialization of new products or custom services. Make complex scientific observations, maintain detailed documentation, and uphold professional/industry standards. Act as a scientific expert and leader, seeking improvements and expansion of scientific concepts to enhance efficiency and business growth. Train and mentor R&D team members, perform lab duties for research and development projects, and oversee lab operations for developing antibody products and reagents. Job responsibilities below: Act as Subject Matter Expert (SME) in specific areas, e.g., B-cell cloning.Serve as key driver/champion on project teams.Perform lab operations, including tissue staining, antibody activity evaluation, and reagent formulation according to established procedures.Analyze and review methods as needed during processes.Lead R&D projects, collaborating with cross-functional departments.Train and oversee laboratory personnel, including new staff members.Seek improvements and expansion of scientific concepts to enhance efficiency and business growth.Ensure quality requirements and deadlines are met.Develop, write, and update documents related to lab procedures and product manufacturing to maintain cGMP and ISO compliance; write lab reports or project summaries as needed.Collect, analyze, and interpret data from verification testing to ensure products meet specifications.Complete all work in compliance with cGMP, FDA, OSHA, USDA, EPA, ISO, and Quality System regulations to assure quality and regulatory standards.Develop new assays as required.Manage development and transfer of manufacturing processes, including instrumentation and staff training.Participate in implementing cGMP and ISO compliance standards and assist with manufacturing process investigations.Clean labware and maintain general lab cleanliness.Maintain inventory of chemicals and supplies for laboratory needs.Perform equipment maintenance as necessary. Who You Are: Minimum Qualifications: Ph.D. in Chemistry, Biochemistry, or other Life Science discipline with 1+ years of lab experienceMaster's Degree in Chemistry, Biochemistry, or other Life Science discipline with 3+ years of lab experience Bachelor's Degree Chemistry, Biochemistry, or other Life Science discipline in Scientific discipline with 8+ years of lab experience. Preferred Qualifications:Knowledge of regulatory and standard requirements applicable to the site, i.e., MDSAP, ISO 13485, IVDRProficiency in protein detection technologies, such as ELISA and immunostaining.Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.Experience with organizational, time management, and project 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.Ability to design and carry out experimental procedures in the laboratory without supervision.Experience with Microsoft Office: PowerPoint, Excel, Word.Experience following Standard Operating Procedures, accurate completion of Manufacturing Procedure batch records, adherence to Quality and Regulatory requirements.A background and/or working experience with equipment in a regulated laboratory environment.Experience with immunoassays, tissue staining, the use of an autostainer, cover slipper, and other IHC equipment.