Technical Reviewer

Description

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

Summary:

The Technical Reviewer demonstrates excellence in review of all Quality Control Microbiology data, including, but not limited to: environmental monitoring (batch and routine), compendial testing (method development, release, and stability), and supporting laboratory data (growth promotion, diluent preparation, etc.) The Technical Reviewer is also responsible for using their advanced technical acumen to assist in authoring risk assessments, quality events, analytical procedures, standard operating procedures, and protocols.

Essential Duties:

• Performs thorough peer review to ensure accuracy of raw data, calculations, and trending
• Partners with Senior Microbiology Manager, Microbiology Coordinator, and Stability Coordinator to manage expectations and timelines for in-process, release, and stability testing of compendial data
• Partners with Senior Microbiology Manager, Microbiology Coordinator, and Environmental Monitoring Team Lead to manage expectations for batch and routine environmental monitoring as well as cleaning validation/verification, protocol-driven (EMPQ, etc.) and ad-hoc testing
• Authors quality events, risk assessments, analytical procedures, standard operating procedures, protocols, and summary reports
• Actively suggests improvements to test methods and procedures
• Identifies technical or system issues and brings them to the attention of the appropriate personnel for resolution
• Thoroughly documents all activities and reviews all paperwork to ensure completeness and accuracy
• Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
• Assists other laboratory personnel as needed
• Actively participate in laboratory and project/line of sight meetings
• Maintains an orderly and safe working environment
• Strictly adheres to cGMP rules and regulations
• Identify technical or system problems and recommend/implement innovative problem solving approaches
• Other duties as assigned by management

Qualifications

Knowledge, skills, and abilities:

• Ability to manage day-to-day data review activities with respect to departmental and organizational timelines and expectations
• Provide mentoring, guidance, and development opportunities for staff

• Strong laboratory and aseptic techniques
• Strong understanding of cGMP requirements
• Strong understanding and adherence of company SOP’s and requirements
• Strong critical thinking and problem-solving abilities
• Strong mathematical skills
• Excellent attention to detail
• Ability to read, analyze, interpret, and follow standard operating procedures
• Goal-oriented mindset, with strong time management and organizational skills
• Works under moderate supervision
• Relies on experience and judgment to plan and accomplish goals within defined procedures and practices.
• Seeks management direction for problems of diverse scope