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Manager, QC Cell Therapy


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Location: Houston TX

Company Name: Lonza

Occupational Category: 21-1093.00,Social and Human Service Assistants

Date Posted: 2020-02-12

Valid Through: 2020-03-13

Employment Type: FULL_TIME

Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?

Job Description Summary

Key Accountabilities:
• Responsible for supervision of the Cell Therapy lab. 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.
• Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management and production planners when capacity constraints exist.
• Collaborates with QC Technical Services group, Bio Analytical Services team, MSAT, and program management to drive technical transfer, staff training, and assay qualification/validation activities.
• 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.
• Writes, reviews, and/or approves SOPs, sampling plans, protocols, and specifications.
• Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA). Actively works to ensure responses are completed on-time. Escalates roadblocks to completion and provides potential solutions.
• Leads and mentors others with technical investigations.
• Prepares project plans, writes status reports, and gives oral presentations to customers and management.
• Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
• 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.
• Performs other duties as assigned.

Education/Experience:

Bachelor's degree in a scientific discipline and 9+ years relevant experience in a related field. 7+ years experience working in a cGMP environment. 5+ years of applicable leadership experience.

Skills:

Technical Knowledge

Demonstrated knowledge in biological, cell based assays including flow cytometry and PCR.

Experience with method validation and technology transfer preferred.

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.

Computer Skills

Proficient in the use of spreadsheets, databases, and word processing software.

Knowledge of SAP, TrackWise, and LIMS systems a plus.

Decision Making

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.

Planning/Prioritization

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 prioritizaton of work in area. Leads defined work to successful completion on-time or ahead of schedule. Provides suggestions for department priorities.

Communication

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.

Teamwork

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