Manager, Quality Control Stability

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.

The Manager, Quality Control Stability will provide oversight and maintenance of Paragon's Quality Control Stability program. In this foundational role, at our newest manufacturing facility, the successful candidate will create stability study protocols inclusive of study set up and testing coordination both internally and externally.

Key Responsibilities include, but are not limited to:

• Evaluating/tracking/trending results and generating milestone status updates and final stability reports ensuring accuracy and GMP compliance
• As part of an overall Program Team, participate in client meetings regarding stability program as the Quality Control SME in this area
• As part of a matrix environment, this individual will work closely with stakeholders to resolve any quality issues
• Work with Quality Control, Analytical Development and Quality Assurance to schedule stability protocol generation, testing, review and approval
• Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
• Recommends, leads projects associated to and drives to completion all continuous quality improvements in the QC laboratory
• As a key contributor to client audits, this individual will interact in person and via phone to convey information and answer questions.
• Recommend and drive results to quality metrics specific to QC Stability
• Conducts training on applicable SOPs, regulatory requirements and quality initiatives
• Ensure compliance to procedures; perform root cause analyses and trend analyses; develop and implementing corrective actions; improve procedural efficiencies
• Manage and monitor on-time closure of laboratory investigations, deviations, and investigations
• Participate in employee development programs and objective goal setting sessions
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels
• Produce results in a fast-paced environment in order to meet client deadlines, and under minimal supervision
• Ability to learn quickly with a desire for continual development and improvement
• Apply basic scientific and regulatory principles in order to solve operations, as well as routine tasks, in the QC department
• Ability to work within a team setting as well as independently
• Analyze data and complete reports with attention to detail
• Other duties as assigned

Experience & Education:

• Bachelor in a Life Sciences or Chemistry field
• 8 or more years of experience in Quality Control with some or all that time holding a Stability role.
• 4 years of direct people leadership
• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU) specifically related to Stability.
• Experience in writing SOPs and Stability related documentation
• Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve problems related to Quality Control Stability, as well as routine quality tasks
• Ability to succeed in a team-oriented environment under very dynamic conditions

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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