Timothy Grosch Email and Phone Number

Capsugel purchased Xcelience in 2016. I continued my role as Director of Analytical Services at the Tampa location. Lonza then purchased Capsugel in 2017.

Provides leadership to the Analytical Department in order to meet the project, regulatory, scientific and business objectives and goals of Xcelience. Provide technical direction and guidance to the Analytical department in the areas of development, validation, QC Release, pharmacopeia, stability studies. Lead, manage, and help establish policies for the Analytical Department. Maintain a positive, professional, and confidential relationship with internal staff, clients and prospective business partners. Provide administrative personnel management for the Analytical department including performance reviews, accuracy of time sheets, career development, disciplinary actions, participation in interviews, and recommendations to hire replacement or additional resources.Work cross functionally within the organization to facilitate the successful completion of all development projects in a timely manner, meeting all internal, client and regulatory requirements. Participate in meetings and on-site visits as needed with potential and existing clients. Write/review/approve/oversee/implement the following quality documents and or procedures: SOP's, Deviation Reports and CAPAs, OOS/OOT/LIR investigations, and Change controls. Author and/or edit protocols and reports for technical documents. Provide technical advice to executive management team on specific project candidates and make recommendations on future strategic growth areas and capabilities.

GENERAL PURPOSE AND SCOPE:Leadership of staff responsible for department scientific and business development.ESSENTIAL JOB DUTIES:• Leads the operations and program management staff of a complex $3 Million, 15 person, multi-site GMP/GLP laboratory. Developed an atmosphere of success, leading the Operations to exceed client expectations and systematic compliance to quality and regulatory requirements. Oversees the servicing of all existing client accounts and third party testing contracts. • Inspired the team to adapt Lean and basic Six Sigma practices to create visual management linking the daily performance to the operational and strategic targets. Led and utilized Kaizen events to implement and test changed processes.• Drove efficiency gains across sites for productivity improvements and client satisfaction increases. • Established client/chemist relationship where the client is empowered to communicate directly with the chemist working on their project and a means for the chemist to provide signature client service.• Initiates, plans, and implements staff development/training programs covering topic such as: GMP documentation and regulatory compliance, statistical analysis of stability testing results and MS analysis for small and large molecules. • Created new analytical service line to expand testing capabilities and resources to meet both present and future needs. • Identified gaps in talent, and identified people capable of sustained improvement. • Responsible for management oversight of all Quality Management System documents; Deviations, OOS/OOT’s (LIR), CAPA’s and Change Controls.• Oversight of all regulatory; FDA, MHRA and EMA, quality and operational audits.

Leads the operations and program management staff of a complex $14 Million, 88 person, 2 site, GMP/GLP laboratory. Assigned resources (personnel, space, and equipment) as needed to meet revenue and budget expectations. Developed an atmosphere of success, leading the Operations to exceed client expectations and systematic compliance to quality and regulatory requirements. Oversees the servicing of all existing client accounts and third party testing contracts.Inspired the team to adapt Lean and basic Six Sigma practices to create visual management linking the daily performance to the operational and strategic targets. Led and utilized Kaizen events to implement and test changed processes. Reduced cycle time of sample pull to analysis complete from 15 days to 3 days, and work review to report results from 5 days to 2 days.Drove efficiency gains across sites for productivity improvements and client satisfaction increases. The impact resulted in increased net promoter score percentages from 38% to 46% over an 18 month period. Initiates, plans, and implements staff development/training programs. Led or worked in cross functional teams consisting of quality, regulatory, facilities, procurement and safety personnel.Created new analytical service line to expand testing capabilities and resources to meet both present and future needs. Identified gaps in talent, and identified people capable of sustained improvement. Reduced voluntary turn over from 16% to 8% year over year. Reduced operational deviations by 27% and personnel caused laboratory investigations by 32% year over year. Responsible for management oversight of all Quality Management System documents; Deviations, OOS/OOT’s (LIR), CAPA’s and Change Controls.Departmental oversight of all regulatory; FDA, MHRA and EMA, quality and operational audits and responses to any comments/findings.

Serves as Principal Investigator or Study Director for chemistry studies. Responsible for negotiating service pricing for development, validation and stability studies. Has overall responsibility for technical client interactions and the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results. Supervises and coordinates all activities for a group of scientific personnel.Duties and Responsibilities:• Performs general supervisory duties including full range of recruitment activities, full range of performance evaluation activities, schedules work, prepares training plans, and executes Affirmative Action goals in department.• Represents the single point of control for chemistry projects.• Coordinates efforts of the study team.• Manages client relationships for chemistry studies.• Develops protocols and ensures that the protocol and report, including any changes, are approved and in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.• Reviews cost estimates, forecasts, and revenue recognition information for accuracy.• Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified. • Works with the study team to troubleshoot and solve assay problems, as necessary.• Reviews reports for scientific accuracy and completeness.• Provides technical/scientific guidance and leadership to ensure project completion and to other areas of the company.• Leads and sponsors client visits.• Responsible for ensuring that any unforeseen circumstances that may affect the quality and integrity of the study are identified and documented as they occur and corrective action is taken. • Responds to unscheduled deadlines, client needs, crises, etc. without neglecting other duties.• Evaluates data to assure regulatory guidelines and scientific expectations are met.

• Responsible for client communications regarding project definitions and expectations, technical information exchanges, and discussions of project status. • Responsible for reporting development data to clients with comments and suggestions for continued progress.• Planned and conducted appropriate experiments and managed work hours and priorities to meet expected project completion dates. • Responsible for 5 analysts in laboratory documentation review, experimental design and resource allocation for the meeting of client driven timelines. • Authored or edited feasibility, development, verification, and validation reports and stability, method transfer and validation protocols that conformed to client, ICH and in-house SOP’s. • Instructed staff, troubleshot, and performed routine maintenance and qualification of analytical instruments (HPLC (with full suite of detectors), GC, pH meter etc.) and data acquisition systems (Empower and Chem Station). Provided leadership and mentoring to junior-level scientists.• Reviewed and approved all team generated data sets and was responsible for scientific approval of data submitted to the Quality Assurance department. • Assisted management and business development in reviewing client proposals for technical feasibility, development and validation options.

• Lead chemist for analytical projects such as an Antibiotic (Cephalosporin and penicillin homologues) and oncological drug agents. • Analytical chemist member of multi discipline R&D project teams • Provided scientific oversight of third party manufactures for product release testing, laboratory investigations, budget oversight, and timeline adherences. • An employee trainer for GC, HPLC and general laboratory equipment use. • Supervised and lead the group responsible for the proper removal and disposal of pharmaceutical waste products for analytical and stability R&D departments.