ABE GERMANSDERFER
Boca Raton,FL
Summary
Strategic leader with over 25 years of expertise in biotechnology and pharmaceuticals, specializing in process development, quality assurance, and regulatory compliance. Proven ability to lead cross-functional teams, optimize operations, and deliver innovative solutions that drive business success. Adept at navigating complex regulatory environments and spearheading initiatives that enhance efficiency and compliance. Recognized for fostering team empowerment, achieving measurable results, and maintaining a focus on continuous improvement.
Overview
12
12
years of professional experience
Work History
Principal
CMCStats LLC
03.2022 - Current
- Quality by Design (QbD): Applied systematic principles to ensure pharmaceutical products meet patient needs and performance standards.
- Statistical Process Control (SPC): Developed advanced SPC programs, including multivariate monitoring, for robust quality systems.
- Process Validation: Designed and validated manufacturing processes using DOE, SPC, and risk management tools, ensuring consistent product quality.
- Risk Management: Implemented FMEA and cause-effect tools to identify risks and establish control strategies in development and validation.
- Contract Manufacturing Support: Provided statistical expertise for pharmaceutical and medical device CMOs in development, validation, and risk management.
- Acceptance Sampling & Criteria: Developed scientifically sound acceptance criteria and sampling plans per regulatory standards.
- Design Controls: Applied DOE, SPC, and risk management throughout design verification, validation, and transfer phases.
- Reliability Analysis: Assessed product reliability using statistical methods for failure prediction and durability analysis.
- Measurement Systems Analysis (MSA): Ensured accuracy and precision of measurement systems through gauge R&R and validation processes.
Head of Manufacturing Science and Technology
Telavant Inc (Acquired by Roche)
08.2023 - 12.2023
- Directed combination product development, ensuring regulatory readiness in 3 months.
- Designed FDA filing strategies, reducing regulatory approval timelines.
- Partnered with CMOs to establish supply chain for drug and device components.
- Conducted Human Factors studies to improve usability, increasing IFU effectiveness.
- Self-motivated, with strong sense of personal responsibility.
- Played pivotal role in Roche’s $7B acquisition by ensuring project milestones were met on schedule.
Senior Director, Quality
Charles River Laboratories
12.2022 - 08.2023
- Spearheaded process scale-up efforts, reducing production time.
- Led complex investigations, resolving critical deviations that could impact compliance.
- Implemented training programs, increasing team productivity metrics.
- Authored technical registration documents, ensuring adherence to regulatory requirements.
- Achieved departmental goals by developing and implementing strategic plans and initiatives.
- Increased employee satisfaction, providing regular coaching and feedback sessions.
- Led cross-functional teams to successfully launch new products, meeting deadlines and budgets.
Senior Director, Process Development
Allogene Therapeutics
04.2019 - 12.2022
- Established and led 20-member Quality Engineering team, completing validation projects.
- Enhanced Quality Management System, achieving compliance improvements.
- Defined comparability approaches, reducing regulatory review times.
- Managed facility requalification and aseptic process validations.
- Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
- Directed design and execution of business transformation initiatives to drive performance, profit optimization and growth opportunities.
- Established data-driven decision-making processes and implemented best practices in analytics to optimize performance across organization.
Global Head, Manufacturing Science and Technology
SHL Medical
04.2016 - 04.2019
- Oversaw global product transfers for 14 autoinjector products, achieving commercial production readiness.
- Streamlined manufacturing processes, reducing defects by 98% and improving throughput.
- Implemented operational excellence initiatives, resulting in $10 million annual savings.
- Proved successful working within tight deadlines and fast-paced environment.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Global Head, Manufacturing Science and Technology
Novartis
01.2013 - 04.2016
- Led global validation strategies across 38 manufacturing sites, ensuring regulatory compliance.
- Contributed to development and commercialization of CAR-T therapy, securing FDA approval for Kymriah.
- Introduced statistical methodologies that improved process efficiency and reduced costs.
- Mentored global technical teams, increasing competency in validation processes.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Proven ability to learn quickly and adapt to new situations.
- Excellent communication skills, both verbal and written.
Education
Master of Science - Biotechnology
Worcester Polytechnic Institute
Worcester, MA04.1997
Bachelor of Science - Biotechnology & Chemistry
Worcester Polytechnic Institute
Worcester, MA09.1996
Skills
- Process Development & Scale-Up
- Regulatory Compliance & Submissions
- Quality Assurance & Risk Management
- Technology Transfer & Manufacturing Science
- Team Leadership & Development
- Operational Excellence & Statistical Analysis
- Strategic Planning & Stakeholder Collaboration
- Statistical software proficiency
- Regulatory Systems: [eg, VIVA, LIMS, TrackWise]
- Manufacturing Processes: [eg, GMP, CPV]
Accomplishments
- Spearheaded Telavant BLA submission which redefined performance goals and achieved annual benchmarks.
- Managed to get the product ready for autoinjector implementation in less than 3 months.
- Supervised team of more than 200 staff members.
Languages
Russian
Native or Bilingual
Timeline
Head of Manufacturing Science and Technology
Telavant Inc (Acquired by Roche)
08.2023 - 12.2023
Senior Director, Quality
Charles River Laboratories
12.2022 - 08.2023
Principal
CMCStats LLC
03.2022 - Current
Senior Director, Process Development
Allogene Therapeutics
04.2019 - 12.2022
Global Head, Manufacturing Science and Technology
SHL Medical
04.2016 - 04.2019
Global Head, Manufacturing Science and Technology
Novartis
01.2013 - 04.2016
Master of Science - Biotechnology
Worcester Polytechnic Institute
Bachelor of Science - Biotechnology & Chemistry
Worcester Polytechnic Institute
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