Manager, Quality Control - Cell Culture

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 - Cell Culture will oversee the QC Cell Culture lab including people leadership responsibilities. The functional attributes to this role include the preparation/propagation of biological materials such as media, solutions and cell culture. Opportunities to optimize processes and methods as well as increasing lab analyst capabilities.

Key Responsibilities include but are not limited to:

• Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Review of test results for accuracy and GMP compliance
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation
• Participate in client meetings regarding the cell culture program
• Work closely with Manufacturing and Quality Assurance staff to resolve quality issues
• Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
• Participates and carries out continuous quality improvements in the QC cell culture laboratory
• Participate in answering cell culture related questions during audits
• Provide input to quality metrics specific for cell culture
• 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

SCIENTIFIC/TECHNICAL EXPERTISE:
• Experience in Cell Culture, Aseptic Technique, micro pipetting, and Media/Buffer Preparation in a laboratory setting is a requirement.
• Builds credibility within the group by performing high quality work
• Familiarity with Good Manufacturing Practices (GMPs)
• Teaches others regarding his/her expertise, mentors and trains other members of the QC group in regards to day-to-day lab activities and team goals
• Effectively communicates results of own work through presentations, discussions, and documentation with some input from supervisor

Education & Experience:

• Bachelor's degree in Life Science field
• 10 or more years experience within the biologic or pharmaceutical industry with at least 5 years performing direct hands-on work in a QC function with a strong familiarity of GMP practices
• 4 years of direct people leadership experience
• 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.
• 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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