Tess Bassing
Kansas City
Summary
Dynamic Project Manager with a proven track record at Catalent Pharma Solutions, excelling in client communication and budget management. Expert in project planning and cross-functional collaboration, successfully delivering projects on time. Recognized for driving quality assurance initiatives that enhance client satisfaction, and operational efficiency.
Overview
20
20
years of professional experience
Work History
Project Manager - Biologics
Catalent Pharma Solutions
Kansas City
12.2021 - Current
- Supports or leads PM teams, cross site teams or functional teams in Department, Site or Global PM projects, activities and initiatives.
- Promotes continuous improvement in all aspects of the job: Coordination with sales, operations, client services, and QA to ensure the highest level of client service.
- Manages projects that may reside within single or multiple business lines or sites as assigned.
- Acts as single point of contact for the client and facilitate responses to Customer questions and observations.
- Preparation and management of a Project Plan to meet required milestones.
- Lead meetings with client and internal teams to facilitate project completion.
- Deliver the project within agreed upon timeline and budget.
- Provides notification of milestone completions for billing to finance.
- Primary client communication focal point for project team.
- Client advocate.
- Speaks to all Catalent business services and promotes Catalent at client meetings and conferences.
- Works with sales to win new business.
- Proficient in technical aspects of PM related software used by site.
Quality Specialist III – Client Services QA
Catalent Pharma Solutions
Kansas City
07.2020 - 12.2021
- Support all activities related to the Client Audit program for KCM.
- Participate in pre-audit activities including scheduling with internal and external clients, and reviewing past client audits, deviations/complaints, and current projects.
- Create client specific agendas and schedule pre-audit meetings with internal associates assigned to the project.
- Serve as a link between Catalent internal team members and the client.
- Aid in ensuring all timelines related to the Client Audit program are met.
- Be attentive and responsive to all Quality auditors and clients.
- Provide a consistent approach to clients, and across all departments, to offer high quality customer service.
- Possess a basic understanding of all Catalent business lines to aide in discussions related to new business opportunities.
- Establish and maintain close working relationships with KCM audit stakeholders to ensure client needs are met.
- Respond promptly and accurately to all client audit requests.
- Demonstrate a working knowledge of SOPs and other GMP documentation.
- Interact closely with SMEs, answer auditor questions, act as audit scribe and summarize the audit close-out meeting.
- Communicate possible observations, as discussed at audit close out, and interact with Operations Management to ensure timely response to client audit reports post-audit.
- Possess an understanding of the processes, technical issues and requirements of all the individual business lines as well as Catalent’s integrated offerings.
Quality Specialist II – Client Services QA
Catalent Pharma Solutions
Kansas City
03.2016 - 07.2020
- Support all activities related to the Client Audit program for KCM.
- Participate in pre-audit activities including scheduling with internal and external clients, and reviewing past client audits, deviations/complaints, and current projects.
- Create client specific agendas and schedule pre-audit meetings with internal associates assigned to the project.
- Serve as a link between Catalent internal team members and the client.
- Aid in ensuring all timelines related to the Client Audit program are met.
- Be attentive and responsive to all Quality auditors and clients.
- Provide a consistent approach to clients, and across all departments, to offer high quality customer service.
- Possess a basic understanding of all Catalent business lines to aide in discussions related to new business opportunities.
- Establish and maintain close working relationships with KCM audit stakeholders to ensure client needs are met.
- Respond promptly and accurately to all client audit requests.
- Demonstrate a working knowledge of SOPs and other GMP documentation.
- Interact closely with SMEs, answer auditor questions, act as audit scribe and summarize the audit close-out meeting.
- Communicate possible observations, as discussed at audit close out, and interact with Operations Management to ensure timely response to client audit reports post-audit.
- Possess an understanding of the processes, technical issues and requirements of all the individual business lines as well as Catalent’s integrated offerings.
Proposal Lead
Catalent Pharma Solutions
Kansas City
03.2015 - 03.2016
- Works collaboratively with clients, Business Development and operations (both ADT and CSS) to generate quotations per client request.
- Organize, plan, coordinate and prioritize to meet client timelines.
- Participates in client visits and teleconferences.
- Collaborates with Project Management to amend current contracts.
- Works with Finance to ensure compliance.
- Attend site SQDC to present current open opportunities.
- Software applications include Voyager, Excel and Microsoft Word.
Quality Specialist II
Catalent Pharma Solutions
Kansas City
06.2013 - 03.2015
- Review/audit of Stability and Technical Reports.
- Review, approval and issuance of Certificates of Analysis (CofA) and Analytical Results Forms (ARFs).
- Review and approval of analytical methods, specifications and protocols.
- Review of analytical deviations and investigations to methods, specifications, protocols and SOPs.
- Review/audit of compendia testing of raw materials.
- QA Log-In of documents for review.
- Analytical laboratory facility walk-thru/audit.
- Presented monthly FDA compliance documents from other companies as learning tool for PAC QA.
- Trained on batch record pre-approvals.
- Presented training on bioassays and immunoassays to PAC QA.
Scientist
Catalent Pharma Solutions
Kansas City
02.2005 - 06.2013
- Responsible for writing protocols, reports, methods and controlled forms used for testing.
- Write and maintain Standard Operating Procedures within the bioassay and immunoassay group.
- Responsible for validating new laboratory instrumentation as well as routine calibration activities.
- Write documentation pertaining to the IQ/OQ/PQ of new laboratory instrumentation.
- Perform bioassay and immunoassay testing for drug product and drug substance such as Plaque Reduction Neutralizing Tests, ELISA’s and RT-PCR for stability and release samples in a GMP environment.
- Conduct and produce laboratory analysis documentation in accordance with applicable SOPs, methods, protocols, and specifications.
- Provide peer review with accuracy and in accordance to applicable SOPs.
- Successfully executed transfers and/or validations of GMP bioassays and immunoassays.
- Responsible for cell lines used in bioassays as well as performing membrane preparations.
- Assisted in the successful training of multiple new personnel within the group.
- Interim Group Lead for Bioassay group (5 reports).
- Maintained Bioassay testing schedule.
- Annual training in GMP, Bio Safety-Blood Borne Pathogens, Chemical Hygiene and RCRA – Hazardous Waste.
- Accountable for reagent preparation as well as ensuring stocked materials and supplies.
- Participate in Lean Six Sigma activities to improve on internal processes.
- Participate in the Laboratory Safety Team Committee.
- Participate in the Catalent Fun Committee.
Education
Master of Science - Cellular and Molecular Biology
University of Missouri
Kansas City, Missouri01-2005
Bachelor of Science - Biology
University of Missouri
Columbia, Missouri01-2003
Skills
- Project management
- Client communication
- Quality assurance
- Budget management
- Project planning
- Cross-functional collaboration
Work Phone
816-767-6737
Publications
- The P2Y2 Nucleotide Receptor Mediates UTP-induced Vascular Cell Adhesion Molecule-1 Expression in Coronary Artery Endothelial Cells., 2003, Seye, C.I., Yu, N., Jain, R., Kong, Q., Minor, T.M., Newton, J., Erb, L., Gonzalez, F.A., Weisman, G.A.
- The Role of Extracellular UTP in the Development of Arterial Disease., 2002, Minor, T.M., Yu, N., Kong, Q., Seye, C., Weisman, G., Poster Presentation, F21C Nutritional Sciences Program
External Courses And Meetings Attended
- Miller Heiman Strategic Selling Sales Training, 2015
- Innovative Approaches to Quality Systems and Management Responsibility, 2013
- Data Integrity, Quality Metrics, Investigations and CAPA, 2019
Timeline
Project Manager - Biologics
Catalent Pharma Solutions
12.2021 - Current
Quality Specialist III – Client Services QA
Catalent Pharma Solutions
07.2020 - 12.2021
Quality Specialist II – Client Services QA
Catalent Pharma Solutions
03.2016 - 07.2020
Proposal Lead
Catalent Pharma Solutions
03.2015 - 03.2016
Quality Specialist II
Catalent Pharma Solutions
06.2013 - 03.2015
Scientist
Catalent Pharma Solutions
02.2005 - 06.2013
Master of Science - Cellular and Molecular Biology
University of Missouri
Bachelor of Science - Biology
University of Missouri
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