Associate Director-Microbiology/ Environmental Monitoring
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Manages the QC Microbiology team which is responsible for environmental monitoring (routine and production), utility monitoring, and microbiology testing such as bioburden, endotoxin, gram stain, and growth performance qualification. Responsible for oversight of the environmental monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and Lonza policy.
- Responsible for supervision of the Microbiology team. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
- Responsible for development of site Environmental and Utility monitoring programs and policies. Ensures sampling plans are up to date and executed as planned.
- Owns site environmental monitoring and utility trend program. Hosts monthly trending meetings, responsible for sharing trend information with the site Quality Council, and identifies and escalates adverse trends appropriately. Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
- Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
- Writes, reviews, and/or approves SOPs, sampling plans, and protocols.
- Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management, program management, and production planners when capacity constraints exist.
- Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions.
- Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
- Prepares project plans, writes status reports, and gives oral presentations to customers and management.
- Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances.
- Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
- B.S degree required in science concentration preferred
- Highly experienced knowledge in Quality Control
- Experienced knowledge in leadership/ management role
- Working knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required.
- Experience performing trending of environmental/utility monitoring data and conducting contamination/excursion investigations required.
- In-depth understanding of concepts and principles in own discipline and a basic knowledge of these elements in other areas. Stays aware of new technologies and potential applications in area.
- Develops training plans and performs identification and remediation of training gaps.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Knowledge of SAP and TrackWise systems a plus.
- Uses experience and knowledge to solve problems, make decisions or make plans for their area. Makes recommendations for department. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and delays in overall schedules.
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
- Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.
- Demonstrated experience in management of complex tasks and projects.
- Develops goals and objectives for team to maintain focus and meet department goals. Develops and monitors performance measures to understand effectiveness, efficiency, and quality of the group. Routinely assesses resource utilization.
- Uses knowledge of site/customer projects and priorities to direct prioritization of work in area. Leads defined work to successful completion on-time or ahead of schedule. Provides suggestions for department priorities.
- Is able to express information to individuals or groups taking into account the audience and nature of the information (i.e. explain technical concepts to non-technical audiences). Presents ideas in a persuasive manner. Communicates frequently with members of other departments and customers.
- Uses mediation skills to avoid or resolve conflict. Is able to deliver criticism in a constructive manner.
- Applies active listening skills using reflection, restatement, questioning, and clarification.
- Communicates thoughts, ideas, information, and messages which may contain technical information in a logical, organized, and coherent manner.
- Actively works to establish strong working relationships within the group, between groups, and with other department managers to improve harmonization and effectiveness.
- Capable of leading teams and identifying appropriate path to meet team objectives.
- Helps develop loyalty and trust with customers. Able to make and deliver on promises of projects within group control.
- Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
- Demonstrated leadership skills as well as team building and mentoring skills.
- Sets and delivers on individual and team objectives that support the company strategy. Takes personal accountability for both his/her own and the team's actions.
- Can be counted on to ensure his/her own and team's routine work assignments and projects are completed on time or ahead of time without routine reminders.
- Leads by example – models good behavior, work ethic, and teamwork.
- Ensures delivery excellence for own goals and those of his/her team. Overcomes roadblocks to task/project completion through creative/strategic thinking while maintaining quality standards.
- Champions change speaking positively to and about others in all situations. Encourages a positive, solutions-focus attitude in all team members.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.