Melissa Quick
Apex,NC
Summary
Passionate biotech leader with two decades of industry experience and a demonstrated ability to effectively communicate, lead and influence stakeholders at all levels of an organization. Skilled in building consensus among diverse teams to foster collaboration and drive impactful outcomes.
Overview
22
22
years of professional experience
Work History
Head of Operational Readiness
Fujifilm Diosynth Biotechnologies
08.2023 - Current
- Responsible for ensuring FDB’s largest investment to date, $2 billion large scale cell culture manufacturing facility is operationally ready. Once completed, the facility will be the largest CDMO in North America.
- Establish and implement governance processes supporting highly complex and cross-functional integrated schedules for 6 buildings, 15+ functions and special projects.
- Establish and implement Key Performance Indicators to provide an early indicator of project success.
- Proactively identify and mitigate risks to ensure timing, budget and quality targets are achieved.
Vice President, Enterprise Business Planning
Fujifilm Diosynth Biotechnologies
04.2020 - 08.2023
- Developed and maintained the FDB Enterprise Business Planning process aligned with current and future FDB core service offerings.
- Provided visibility and clarity to the FDB growth strategy and ensured the plan was credible, deliverable and visible.
- Collaborated cross-site and cross-functionally along with Executive Sponsors to establish, develop and maintain the growth strategies and plans for core service offerings.
- Led FDB's Customer Experience program that is focused on ensuring we have the best practices and tools in place that support us in delivering on our core values of trust, delighting our customers, genki and gemba.
- Led a team responsible for FDB's commercial systems ensuring we have user friendly and integrated tools allowing for efficient input and clear output visualization to enable thorough and quick decision making.
- Key team member responsible for $5Bn in investments approved in last 3 years.
VP, Program Management and S&OP
FUJIFILM Diosynth Biotechnologies
07.2019 - 04.2020
- In addition to Head of Program Management responsibilities, also responsible for:
- Collaborating with cross-site and cross-functional teams to support project planning so that we provided our customers with the project delivery plans that best supports their program.
- Building competent teams by way of strong leadership and leading by example.
- Challenged and collaborated with leadership team colleagues to ensure we were providing our customers with an exceptional customer experience.
Head of Program Management and S&OP
Fujifilm Diosynth Biotechnologies
08.2015 - 07.2019
- Responsible for ensuring successful program delivery and customer satisfaction for 30+ customer programs running across site at any given time.
- Managed R&D and manufacturing plans ensuring commitments were met and/or exceeded through forecasting and planning new work and contingency planning for existing programs.
- Managed and mentored a group of 10+ program managers ensuring adherence to program management best practices and demonstration of the organization’s core values.
- Led the site’s Sales and Operations Planning (S&OP) process ensuring the short and long term plans for the site were visible and risks identified early to allow mitigation.
Director, Customer Program Management
FUJIFILM Diosynth Biotechnologies
08.2014 - 08.2015
- In addition to Associate Director, Customer Program Management responsibilities, responsible for:
- Managed program managers and ensured their program delivery plans were adhering to our best practices including early identification of risks to allow for mitigation and communications with internal stakeholders and external communications were clear and concise.
Associate Director, Customer Program Management
Fujifilm Diosynth Biotechnologies
07.2013 - 08.2014
- Managed multiple customer programs including successful management of a fast track PPQ program with highly aggressive timelines.
- Established and maintained strong working relationships cross-functionally across the FUJIFILM Diosynth network.
- Fostered collaborative partnerships with our customers.
- Facilitated program tier meetings to ensure program delivery across the site was visible and risks were reviewed and communicated to allow mitigations and escalations as needed.
- Developed and ensured on time approval of scope of works and change orders to allow uninterrupted execution of the program.
- Managed stakeholders through timely communication of relevant program updates / escalations.
Quality Assurance Technical Specialist
Fujifilm Diosynth Biotechnologies
07.2012 - 07.2013
- Provided quality oversight of assay qualifications, tech transfers, method validations and verifications ensuring ICH requirements were met.
- Led stability program by collaborating with the customer and the Quality Control / Analytical Development groups to author stability protocols, ensure all stability pulls were on time and reports were issued in a timely manner to meet the customer’s needs.
- Reviewed deviations, laboratory investigations and test plans for atypical and OOS investigations to ensure root cause was determined and appropriate corrective / preventive actions were put in place to prevent reoccurrence.
Senior Scientist
Merck
06.2010 - 07.2012
- Conducted engineering studies to support start-up / licensure of bulk vaccine facility and technical investigations to allow implementation of sustainable long term solutions / process improvements.
- Utilized process and laboratory derived data to support technical investigations and aide in process optimization / development.
- Authored deviations, technical protocols, reports, and Standard Operating Procedures.
- Participated in the transfer of process analytical technologies to the cGMP manufacturing facility.
Quality Assurance Technical Specialist
Fujifilm Diosynth Biotechnologies
04.2008 - 06.2010
- Supported Laboratory Investigation, Interim Report, Deviation, CAPA, OOT, Invalid Assay, and EM excursion review and closure
- Led weekly customer teleconferences providing current deviation and CAPA status to customers
- Provided Trackwise (deviation system) training to facility
- Monitored and communicated deviation and CAPA load, target activity, and trends to management on a routine basis to ensure ownership is clear and early trends were observed within a timely manner
- Provided audit support.
Cell Culture Coordinator
Fujifilm Diosynth Biotechnologies
07.2006 - 02.2007
- Coordinated and scheduled all activities necessary to keep the cGMP manufacturing operations of multiple suites running smoothly.
- Worked with facilities and QA to schedule equipment and room maintenance and room releases not impacting planned production.
- Coordinated equipment validation and requalification efforts as well as sampling for cleaning validation.
- Ensured instrument calibration were current and would not disrupt manufacturing activities.
- Authored, trained and reviewed Standard Operating Procedures, Batch Records and Formulation Records.
- Assisted with transfer of processes from Process Development laboratory to manufacturing facility
- Assisted with management of manufacturing planning and scheduling.
Research Specialist
Fujifilm Diosynth Biotechnologies
03.2003 - 07.2006
- Responsible for developing and tech transferring microbial and mammalian programs from the customer into the process development laboratories
- Responsible for successful transfer from process development into the cGMP manufacturing facilities
- Supported customer manufacturing campaigns by providing technical support through on the floor support and through investigations.
Research Supervisor
Children’s Hospital
12.2001 - 02.2003
- Supervised and maintained a hybridoma facility, including isolation of new monoclonal antibodies and maintenance of existing antibodies.
- Managed the lab with respect to ordering supplies, training and supervising visiting scientists and lab personnel and implementing new laboratory techniques.
- Presented research findings at weekly lab meetings and scientific meetings and assisted the principal investigator in manuscript writing, presentations at scientific meetings and grant preparation.
Education
Master of Science - Biology
University of North Carolina
05.2001
Bachelor of Science - Biology Concentrating in Environmental Biology and Zoology
University of North Carolina
05.1999
Timeline
Head of Operational Readiness
Fujifilm Diosynth Biotechnologies
08.2023 - Current
Vice President, Enterprise Business Planning
Fujifilm Diosynth Biotechnologies
04.2020 - 08.2023
VP, Program Management and S&OP
FUJIFILM Diosynth Biotechnologies
07.2019 - 04.2020
Head of Program Management and S&OP
Fujifilm Diosynth Biotechnologies
08.2015 - 07.2019
Director, Customer Program Management
FUJIFILM Diosynth Biotechnologies
08.2014 - 08.2015
Associate Director, Customer Program Management
Fujifilm Diosynth Biotechnologies
07.2013 - 08.2014
Quality Assurance Technical Specialist
Fujifilm Diosynth Biotechnologies
07.2012 - 07.2013
Senior Scientist
Merck
06.2010 - 07.2012
Quality Assurance Technical Specialist
Fujifilm Diosynth Biotechnologies
04.2008 - 06.2010
Cell Culture Coordinator
Fujifilm Diosynth Biotechnologies
07.2006 - 02.2007
Research Specialist
Fujifilm Diosynth Biotechnologies
03.2003 - 07.2006
Research Supervisor
Children’s Hospital
12.2001 - 02.2003
Master of Science - Biology
University of North Carolina
Bachelor of Science - Biology Concentrating in Environmental Biology and Zoology
University of North Carolina