- I enjoy cooking and baking, hiking, learning French, and spending time with my family and friends.
Hi, I’m
Allison C. Zugell, Ph.D.
Pottstown,PA
Summary
Dynamic professional with a proven track record at Johnson & Johnson, excelling in cross-functional collaboration and data analysis. Expert in Chemistry, Manufacturing, and Control (CMC) teams and biopharmaceutical development, with a knack for enhancing project management processes. Demonstrated success in regulatory submissions, underpinned by strong problem-solving skills and a commitment to advancing organizational objectives.
Overview
9
years of professional experience
Work History
Johnson & Johnson
Analytical Development Scientific Integrator
11.2021 - Current
Job overview
- Facilitated project team meetings, cross-functional communication and decision-making to align with internal and external stakeholders.
- Used technical expertise to support research reports, presentations and data analysis.
- Contributed to improving project management processes and tools to drive ongoing productivity across departments.
- Developed cross-functional project plans within CMC teams, maintaining connection and understanding to business relevance and strategy.
- Drove development and managed execution of high-quality, integrated cross-functional plans and schedules to support projects.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
Johnson & Johnson
Bioanalytical Scientist- Separations
11.2015 - 11.2021
Job overview
- Simultaneously managed several complex projects, meeting all pertinent milestones for early phase and late phase clinical development.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with HPLC and UV-Vis assays or instrumentation.
- Maintained accurate records of all methods and research conducted and wrote in-depth development and validation reports to support regulatory submissions.
- Led method transfer activities to QC labs to support process validation and commercial testing.
- Proven ability to learn quickly and adapt to new situations.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Versatile professional with strong problem-solving skills and history of adapting to diverse challenges.
- Committed to streamlining processes and advancing organizational objectives.
Education
U.S. Naval Research LaboratoryWashington, DC
NRC Postdoctoral Fellowship from Biochemistry
11-2015
University Overview
- Enhanced methods to quantitatively characterize polymer biodegradation and identify enzyme populations in environmental cultures
- Led a team of federal scientists to characterize physiological and biochemical properties of the thermophilic bacterium Thermus scotoductus during microwave radiation growth using DLS, UV-vis, FTIR, AFM, SEM, and TEM analysis (published in 2015, provisional patent filed in 2015)
- Established a protocol to grow the filamentous fungus Neurospora crassa in continuous stirred tank bioreactors (CSTRs) and analyzed gene expression (published in 2014)
Texas A&M UniversityCollege Station, TX
Ph.D. from Biochemistry & Biophysics
12-2013
University Overview
- Independently developed an anaerobic procedure to isolate intact vacuoles from S. cerevisiae in bioreactors and improve yield by 4-fold (published in 2011)
- Separated and characterized molecules involved in S. cerevisiae iron trafficking using LC ICP-MS
- Collaborated with an interdisciplinary team to collect and publish studies on iron metabolism in Mus musculus brain and liver tissues and mitochondria (published in 2012,2013, and 2014)
Texas Lutheran UniversitySeguin, TX
Bachelor of Science from Chemistry
05-2008
Skills
- Chemistry, Manufacturing, and Control (CMC) Teams
- Biopharmaceutical drug discovery and development
- Data analysis and phase-appropriate analytical control strategy
- Cross-functional collaboration with development and commercial teams
- Authoring and reviewing regulatory submissions and responses to health agency questions
- Program management
Accomplishments
- Reviewed and authored regulatory dossiers and amendments (IND/IMPD) for projects in clinical development phases 1-3 and responded to health agency questions.
- Led high-profile scientific investigations for programs in early and late clinical development, and developed a process and template to help determine root cause and effectively communicate with senior leaders across the organization.
- Collaborated with global sites and external labs to complete analytical method transfers for commercial testing.
- Developed and implemented strategy for setting data-driven acceptance criteria for method validation and transfer activities in late development programs.