Job Description

Main Accountabilities and tasks

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office
• The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for QC and transfer activities
• These activities include the timely qualification of in-process and release testing of drug delivery systems, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory
• The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly
• Review and approval of customer manufacturing batch record
• Responsibilities include hiring, training, goal setting, and performance evaluation
• The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions
• Additionally, the manager serves as the primary technical liaison with clients and Regulatory Bodies
• Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing
• Build a trained, competent team of QC analysts to support GMP testing
• Coordinate any required daily Quality Control activities
• Ensure compliance, accuracy, and timeliness of testing processes
• Lead the introduction of new technology, equipment, methodologies, and validations
• Provide QC leadership and support across the organization
• Hire and develop employees within the department
• Assign work, coach staff, and take vital disciplinary actions
• Serve as primary QC Bioanalytical contact for regulatory inspections and client audits
• Provide support for method qualification and validation from Assay Development and Analytics and/or clients
• Provide frequent overall departmental feedback to senior management
• Ensure adequate staffing is hired and trained

Qualifications

Work Experience : 5-7 years of experience manufacturing in a highly regulated quality control lab environment.

Education : Bachelor’s degree

Other:

1. Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required
2. Experience with regulatory inspections from the FDA, EMA, Notified Body, or other regulatory authorities required
3. Capable of writing reports, business correspondence, and procedure manuals
4. Strong organizational skills with the ability to prioritize and lead through complex processes/projects
5. Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents
6. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
7. Ability to effectively present information to employees, top management, public groups, and/or boards of directors
8. Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form
9. Ability to define problems, collect data, establish facts, and draw valid conclusions
10. Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems
11. Able to lead abstract and concrete variables in situations where only limited standardization exists
12. Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
13. Ability to work well with subordinates, peers, and superiors in all departments.

Additional Information

Benefits we offer:

• An innovative, vibrant and agile culture
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including:
  • Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
  • Employee Savings Plan / 401k with 100% employer match