Act as a senior team member of the Quality Control department to support technology transfer, validation, deviation support, and investigation projects. Subject Matter Expert for all applicable disciplines.  Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles, and may impact future concepts, products, or technologies.  Supports the review of all regulatory documents including APRs, BLAs and IND/NDA.  Direct contact with customers and project teams.  Acts as advisor to leadership staff to meet schedules and/or resolve technical problems.  Troubleshoot assay and instrumentation issues involving data mining, trending and analysis to identify problems.  Provides hands-on and theoretical training as appropriate for QC and other operational groups. Recognized by site and industry as a technical leader.  Maintains current with industry practice and trends through seminars, research, bench-marking

Key Responsibilities:

• Direct all technical transfer projects within their area of responsibility ensuring on-time completion


• Write/review for transfers/validations/deviations/investigations/facility support. Performs assay work and guide others for transfers/validations/ deviations/investigations/facility support


• Represent QC and Lonza in customer meetings to receive/deliver information, requests and requirements. Resolve technical and business decisions as required


• Ensure success of method post technical transfer to include: training of personnel for execution and review, reviewing of data, completion of documentation


• Creates metrics to measure throughput, performance and other appropriate KPIs and report them to management. Identifies, drives and influences others towards completions of department goals. Removes roadblocks for team members to complete their goals.


• Develop the technical, GMP and leadership skills of QC personnel though efficiencies and hands-on training opportunities. Act as mentor to junior staff within the entire QC organization.


• If position has direct reports: complete performance reviews of subordinate QC personnel.  Hold routine 1:1 meetings with staff. Responsible for planning and assigning work, hiring, pay increases, performance management and disciplinary issues as required. Ensure direct report on-time completion of work.

Perform other duties as assigned.

Qualifications:

• Bachelor's Degree in Microbiology, Biochemistry or equivalent Science Field


• 5+ years of relevant experience


• Understands and explains the corporate strategy to his/her peers and/or team


• Provides feedback to his/her managers on the content of the strategy and its implementation


•  Sets and delivers on individual and team objectives that support the company strategy


• Uses knowledge of his/her business area and related areas to make correct and timely decisions


• Proactively seeks to understand internal/external customer and market needs Develops insights that can be used to enhance customer satisfaction or other metrics


• Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate


• Manages internal and external customer relations professionally and effectively Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement


•