Enanta is seeking an enthusiastic and highly motivated Bioanalytical Quality Assurance/Control Specialist, who will be responsible for auditing suitable GLP-regulated bioanalytical contract labs, maintaining effective communication with contract labs to meet project timelines, and reviewing draft/final reports for data integrity and regulatory compliance. She/he will be an integral member of Enanta’s highly collaborative Pharmacology and DMPK/Bioanalysis Department, which is focused on the discovery of novel therapeutics against liver and viral diseases including nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), respiratory syncytial virus (RSV), and hepatitis B virus (HBV), etc.
Primary Duties and Responsibilities:
Audit GLP-regulated bioanalytical contract labs to include review of standard operating procedures (SOPs), study-specific records, training, equipment, facility, and IT records
Review draft and final bioanalytical and toxicokinetics reports for data integrity and regulatory compliance
Oversee GLP-regulated bioanalytical method development, validation, and sample analysis using LC/MS/MS
Maintain effective communication with contract labs to meet project timelines
Interact with multidisciplinary teams (including chemists, toxicologists and clinical managers) to meet project goals and timelines
Communicate unambiguous critical and significant project information to various bodies including project teams and Enanta leadership as required
Collaboration & Teamwork: Relates to employees and management in a cooperative manner that helps others to achieve their best.
Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
Communication Skills: The ability to convey both written and verbal information effectively and efficiently.
Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.
Education, prior work experience, and specialized skills and knowledge:
A bachelor's or higher degree in a regulatory affairs or related field from an accredited institution
In-depth understanding and working knowledge of regulatory requirements for bioanalysis and 21 CFR Part 58 Good Laboratory Practice (GLP) compliance
1 – 2 years GLP Quality Assurance/Control audit experience preferred
Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
Excellent interpersonal skills with an ability to work effectively in a team setting/matrix-type organization
Project management experience preferred to include ability to multi-task and successfully complete projects to meet timelines
Excellent oral and written communication capabilities
Internal Number: PK412
About ENANTA Pharmaceuticals, Inc.
Enanta Pharmaceuticals has used its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Two protease inhibitors, paritaprevir and glecaprevir, discovered and developed through Enanta’s collaboration with AbbVie, have now been approved in jurisdictions around the world as part of AbbVie’s direct-acting antiviral (DAA) regimens for the treatment of hepatitis C virus (HCV) infection, including the U.S. marketed regimens MAVYRET™ (glecaprevir/pibrentasvir) and VIEKIRA PAK® (paritaprevir/ritonavir/ombitasvir/dasabuvir).
Enanta is located in Watertown, MA, just minutes from Harvard, MIT, and downtown Boston. We offer a competitive compensation program and a comprehensive employee benefits package. For more details, see our Careers page.