Summary of Functions:
The Camarillo Manufacturing Site within Curia handles approximately 50-60 clinical fill finish projects per year; this number is growing at double digits. To support this activity, the site has a QC department consisting of an analytical lab, a microbiology lab as well as a team focused on long term stability programs.
Reporting to the Site Quality Head, the QC Director will oversee the QC Analytical, Microbiology and Stability Teams; a group comprised of 25-30 scientists, research associates and lab assistants. This leader ensures the timely completion and proper prioritization of department activities. The individual will be required to anticipate current and future resource needs (both in terms of people, equipment and processes). In addition, the Department Head will also be able to effectively communicate results and issues within the projects to management and customers with the highest professional standards.
Major Duties and Responsibilities:
- Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Department Head will be responsible for improving the overall department productivity, efficiency and profitability.
- Oversee the development and validation of client’s methods and procedures. Assist in the development of client’s stability plans/protocols. Create solutions for the more complex analytical problems that arise within the group.
- Ensure that the analytical, microbiology and stability functions are completed in accordance with site and corporate standards of safety and quality, and all documentation is complete, compliant, and timely.
- Author, support, and/or review OOS and Deviation investigations and Change Control plans and reports.
- Ensure Data Integrity is maintained for all QC laboratory activities, with particular focus on QC instruments, equipment, software, and data management.
- Ensure customer confidence in department results. Acting as the technical leader, this individual will be responsible for providing communication with key members of client organizations.
- Supervise a team of scientists including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals. Recruit, hire and onboard as necessary. Provide mentorship and career development for individuals within the group.
- Allocate resources in accord with project priorities within guidelines set by site and corporate management. Effectively plan resources (human and capital) for growth, to enhance efficiencies and ensure minimal downtime in the QC labs.
- Oversee the implementation of the site’s LMS.
- Responsible for the identification and development of new business opportunities and relationships as appropriate.
- Communicate effectively in both verbal and written form on results, issues and plans. This may involve and include close interactions with customers.
- Ensure that laboratory operations are conducted in a safe manner.
- Routinely improve knowledge and skills in pertinent scientific and supervisory fields by participating in continuing education courses and scientific meetings as appropriate. Participate in self-development activities and training of others.
- Recommend and implement methods and techniques to increase the quality of products and/or services.
- Exhibit safety awareness and safe work practices.
- Perform other related duties as may be reasonably assigned in the course of business.
- B.S. in Analytical or Organic Chemistry or a related field; M.S. or Ph.D. preferred.
- Ten to fifteen years of analytical research and/or quality control, with a GMP pharmaceutical, biotechnology or contract research environment.
- Minimum of five years in a senior leadership role.
- Must possess comprehensive technical knowledge in analytical science including chromatography, spectroscopy and automation.
- Must possess comprehensive knowledge and experience in GMP and CMC requirements.
- Prior experience and knowledge in FDA GMPs (21 CFR Parts 210, 211, 820, and 600); ISO 9001 and 13485.Prior experience with analytical method validation per ICH guidelines.
- Excellent written and oral communication skills.