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GENERAL SUMMARY OF POSITION: 

Under the general direction of the Associate Director or designee, the QC Scientist I is responsible for initiating and executing efforts to characterize and validate new Monoclonal Antibody (MAb) products. The QC Scientist will employ a wide variety of scientific concepts and principles in order to update and optimize methods and procedures used by the Quality Control Department.  Leads a team to the successful execution of departmental projects and achievement of departmental goals.

MAJOR RESPONSIBILITIES:

• Manage the effort to maintain the quality of all assays currently used to test MAb products.
• Develop, validate, and transfer methods used for the characterization of MAbs to QC groups.
• Design and conduct experiments to test clinical samples.
• Establishes relationships with Scientists in other departments and coordinate efforts to optimize assays for transfer to QC. Represent QC in inter-departmental and intra-departmental meetings.
• Assists in compiling manuscripts, posters, and presentations. Writes SOPs, in process forms, and development reports for IND MAb assays.
• Keeps accurate records of experimental data, validation and production procedures according to cGMP guidelines. Ensures records of direct reports also meet this standard.
• Analyzes experimental data and reports to senior management and research collaborators in a timely fashion.
• Serves as a technical resource to the department and conducts moderately complex troubleshooting. Proposes creative problem solving approaches.
• Takes an active role in the organizational aspects of the QC department such as ordering and equipment repair.
• Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
• Performs additional job related duties as required

REQUIRED QUALIFICATIONS:

• Requires a PhD in life science or related field and a minimum of 2 years of relevant experience or equivalent combination of education and work experience. Postdoc experience may be considered relevant experience.
• Ability to motivate personnel to work effectively and efficiently
• Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluations
• Working knowledge of current procedures within the following areas is preferred: cell culture, protein biochemistry, immunochemistry, HPLC, capillary gel electrophoresis, and ELISAs.
• Ability to adapt to a cGMP environment and maintain all work to cGMP standards.
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Excellent problem solving skills as well as time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
• Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization
• Ability to work flexible and at times, extended hours to meet business needs