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Abe Germansderfer

Biotechnology Executive

Address Boca Raton, FL 33486

Phone 954-***-****

E-mail ad3gap@r.postjobfree.com

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Talented Manager with expert team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach. Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations.

Talented leader with analytical approach to business planning and day-to-day problem-solving. Customer-focused professional with successful 25-year career in biotechnology/pharma sector. Dynamic successful applying process development and statistical analysis skills in busy business environment. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Skills

Data Analysis

Excellent

Quality Management

Excellent

Genomics

Good

Cell Biology

Excellent

Quality Auditing

Good

Molecular

Good

Biology

Excellent

Quality Control

Excellent

Manufacturing

Excellent

Medical Devices

Good

Biotechnology

Excellent

DOE

Excellent

SPC

Excellent

Validation

Excellent

Bioassay

Excellent

Fill/Finish Inspection

Excellent

Work History

2023-08 – 2023-12

Senior Director Combination Product, Process Development

Telavant Inc, New York NY - Acquired by Roche

• As the leader overseeing the combination device development and commercialization within the CMC function, I played a crucial role in shaping the project timeline. Responsibilities included crafting an FDA notification and filing strategy, ensuring regulatory compliance. Extensive collaboration with CMOs was undertaken to establish a robust supply chain for drug product and device component production.

• I led the development of a Human Factors study to create the IFU for the device, focusing on user interactions to enhance usability and safety. Additionally, I implemented analytical test methods to assess device functionality at release and during stability studies. This involved creating rigorous testing protocols to ensure consistent device performance throughout its lifecycle.

• In summary, my role encompassed navigating regulatory requirements, collaborating with CMOs for supply chain management, conducting Human Factors studies for IFU development, and implementing analytical testing methods. The objective was to seamlessly integrate the drug product and device components, ensuring compliance and success from development to commercialization. In December 2023, Roche completed the acquisition of Telavant for over $7B.

2022-12 – 2023-08 Head of Manufacturing Science and Technology Charles River Laboratories, Memphis, TN

• Lead MS&T and Deviation Investigations

• MS&T is responsible for process scale-up, purchasing of raw materials and equipment, establishing specifications for raw materials. Creating master batch records and providing general technical support to the production group. Also responsible for large investigations. Using statistical thinking to discover root causes Support comparability study strategies and design to address material, process, and site changes.

• Cross-trained existing employees to maximize team agility and performance.

• Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground. Managed and motivated employees to be productive and engaged in work. Planned and budgeted accurately to provide business with resources needed to operate smoothly.

• Maintained professional demeanor by staying calm when addressing unhappy or angry clients. Partner with CMO and internal Process Development team to define parameters for process qualification

• Provide guidance and direction to address root cause of discrepancies and to define corresponding CAPA. Serve as CMC Quality point person for OOS management, and associated CAPA implementation.

• Oversee the authoring, reviews and revisions of technical registration documents and submissions to regulatory agencies. Partner and align with QC management and/or contract organizations on content of submissions Partners with Regulatory Affairs and Quality to address responses to regulatory requests and comments. Ensure conformance to all regulatory requirements, including FDA and various international regulatory governmental bodies.

• Collaborate with internal and external stakeholders to drive company objectives, to resolve issues and define escalation mechanisms, while ensuring team meets quality and compliance requirements. 2019-04 - 2022-12 Sr. Director, Quality

Allogene Therapeutics

• Responsible for setting strategy for equipment and process validation

• Responsible for establishing the Quality Engineering group

• Hired and oversaw validation staff to qualify greenfield site equipment

• Also was responsible for creating the comparability approach and method used at the company. Responsible for managing approximately twenty people with five direct reports.

• Provide vision and leadership for the Allogeneic quality program; creating a culture of innovation and collaboration with key interfaces both within and outside Allogene, develop and motivate the staff within the group.

• Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and regulatory requirements.

• Review and proactively assist in process capability studies and statistical techniques as necessary, to support continuous improvement

• Initiate updates/tracking on status of Quality Events and CAPAs as

appropriate

• Participate as cross-functional team member for process verification and technical transfer projects

• Lead the product lifecycle requirements

• In conjunction with MS&T & Manufacturing, evaluate Quality Events / Non- Conformances

• Support the identification of corrective and preventive actions; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure

• Participate in the development and maintenance of the Quality System to meet the requirements of the relevant regulatory authorities and ISO standards (as applicable) and all other applicable quality and regulatory standards

• Assist in the audits of contract manufacturers and contract laboratories for GMP compliance as required

• Support in the preparation for regulatory submissions and inspections, as needed

• Own the facility and equipment requalification and aseptic process validation programs.

2016-04 - 2019-04 Sr. Director

SHL Medical, Deerfield Beach, FL

• Lead the Global Process Development organization that defines, develops and deploys strategies for operations performance improvement via implementation of the scientific oversight of the manufacturing processes and technical changes

• Support the optimization of SHL manufacturing processes, enabling full-scale manufacturing through integrated process control strategy and technical support which includes triggering post launch process changes when needed

• Ensure best practice in handling of discrepancy and investigation resolution, equipment and process validation activities and significant changes to manufacturing procedures

• Maintain operational excellence and statistical methods standards that support continuous improvement and to improve process understanding, quality and compliance of the products, efficiency and capability of the processes and to meet performance improvement goals including labor management, process flow and customer satisfaction

• Responsible for definition and maintenance of procedures and processes for successful implementation of product technical transfers either from development to production or between production sites

• Oversee and coordinate product validation activities for new and routinely manufactured commercial products and ensure that products are properly validated according to current GMP and internal SHL standards. 2013-01 - 2016-04 Global Head

Novartis, Basel, Switzerland

• Manufacturing Science and Technology group was responsible for addressing gaps in the global validation strategy and position of Novartis

• In that capacity I was responsible for delivering a set of principles to a global network of manufacturing sites producing, large and small molecule drug substance, formulation, filling, tableting and packaging

• I was also responsible for filing review and addressing regulatory body questions Led divisional and cross-divisional non-clinical statistics networks with the goal of developing and improving competency in this area that meets business needs and regulatory expectations

• Novartis statistics network serves as the expert body in development and deployment of statistical tools that improve process understanding, process quality and compliance, and increase process efficiency and capability

• The network supports multiple functional groups in assuring effective and compliant process and analytical method development transfer and validation Supported the development of the CAR-T manufacturing process and the regulatory strategy Participated in a number of Type C meeting with FDA to explain the control and comparability strategy Created a set of models to monitor process efficiency Responsible for establishing a strategy for setting release and stability specification limits

• Also developed and supported a world wide rollout of the continued process verification (CPV) process Developed and rolled out methodology to automate blend and content uniformity calculations Led and mentored technical groups within the Drug Product, API and Biotech manufacturing network

• Assured through onsite audits that process development, technology transfer and process validation principles established by Global MST are followed by the manufacturing network.

2011-08 - 2012-12 Associate Director

Gilead Sciences

• Led Technical Services (QCTS) group that maintains control and optimum performance of QC through trending of critical test method parameters, test method remediation and operational excellence initiatives

• The group is also responsible for technology transfer among other critical activities.

• Led Laboratory Information Systems group that maintains critical computer systems that support product testing and environmental monitoring.

• Led Stability group that manages stability studies and performs stability data analysis to establish or support product expiry.

• Led the San Dimas site and Gilead Sciences in applying statistical methods and specific analyses that provide flexible solutions in areas of test method validation, process development and validation, acceptance sampling and inspection process and other areas of Quality.

2006-10 - 2011-08 Principal Quality Engineer

Amgen, Thousand Oaks, CA

• Managed and mentored a group of experienced professionals that provides various statistical and quality engineering services to Amgen's device and drug product development and to clinical operations groups

• Supported hundreds of scientists and engineers by providing statistical consulting services in a wide range of areas including product and process development, development of analytical methods, support of quality and manufacturing investigations

• Led company wide improvement and operational excellence projects

• Led adaptation of statistical and risk management components of Quality by Design (QbD) in bio- process, analytical method and drug product development business processes

• Created detailed procedures tools and training describing techniques for calculation Design Space for individual and multiple unit operations

• Managed multi-functional teams tasked with updating quality system to comply with 21st century cGMP and QbD paradigms

• Owned a number of quality system aspects related to sampling and monitoring of process and product quality

• Provide guidance on multiple aspects of Quality and Product

• Development

• Responsible for developing statistically derived specifications

• Implemented various acceptance sampling plans and various statistical process control (SPC) systems

• Developed and implemented a novel control charting system for environmental monitoring data

• Implemented multivariate control charting systems

• Established techniques to demonstrate comparability between analytical methods, stability studies results, processes and small and large scale process characterization models

• Provided advice on analytical method development and validation activities

• Set methodology and support analysis of product stability data

• Supported contract manufacturing, contract quality and regulatory interactions as subject matter expert in the above areas as well as data driven aspects of ICH Guidelines and PAT

2003-03 - 2006-10 Senior Quality Engineer

Amgen

• Led and managed analytical and data analysis projects in support of multiple groups including QC, PD, MFG, and R&D

• Actively participated in analytical method improvement, development, and validation through application of statistical analyses

• Developed systems to trend quality attributes applying Statistical Process Control (SPC) concepts Streamlined data gathering and analysis generation in support of the Quality Management Review (QMR) and Annual Product Review (APR) programs Presented analysis results to peers and senior staff

• Optimized analytical assay performance through ad hoc data analysis and planned experimental design Created tools used to characterize and validate analytical methods Implemented a more accurate and precise method of evaluation of bioassay data As a result, the invalid rate was reduced from 30% to less than 15%

• Contributed to the design of LIMS in the context of SPC Developed programming to interface NWA, Excel, and JMP with current and future versions of LIMS Possess detailed knowledge of production, development and testing of biotech products

• Analyzed historical data in order to create consumer/producer safe specification ranges for in-process controls and release assays. 2000-08 - 2003-03 QA Statistician

Sanofi

• Served as a statistical resource to all Genzyme divisions, and provided day- to-day statistical support to R&D, Process Development, Manufacturing, Quality Assurance and Quality Control

• Supported product stability program Analyzed complex stability study data, derive product expiration dates, and review stability technical reports

• Created a flexible tool to automate stability analysis per ICH and FDA guidelines

• Provided statistics support for ISO9001 Annual Product Review program

• Supported the maintenance of the product testing database, generate summary data tables and charts

• Acquired knowledge of all aspects of drug manufacturing and assays performed to confirm purity and identity

• Provided input during annual review meetings, generates final summary technical report, compiled supporting data file, and monitored corrective action program Developed PL/SQL queries to transfer data into statistical packages and automate analysis

• Responsible for data validation and cleaning through custom application development.

1998-08 - 2000-08 Research Assistant II

Therion Biologics

• Responsible for cloning, subcloning of vaccinia vectors containing HIV, SIV, and other genes in order to create a live vaccinia based vaccine against HIV

• Duties included development of cloning strategies, preparation of transfection quality DNA, and genomic analysis of constructs through enzymatic digestion, sequencing, and PCR Proficient in point mutation, gene wobbling and gene fusion techniques

• Utilized and developed data-mining protocols and Perl and JavaScript applications to screen for similarities between genes of interest Performed computer based sequence analysis using MacVector and web based applications

• Routinely performed sequence and oligo alignments Performed advanced testing of genetic constructs through transient expression, and detection of gene products via ELISA and Western blotting Screened recombinant virus through Southern blotting and PCR analysis.

1998-01 - 1998-08 Technician

Biogen

• Supplied R&D and biochemistry departments with bioprocess product

• Responsible for design, set- up, and running of bioreactors

• Scale up to 200L as well as early stages of downstream processing

• Possess full understanding of programmable controllers and SIP procedures

• Familiar with set-up of cross filtration and large-scale column chromatography

• Responsible for antibiotic free tissue culture of research cell lines

• Monitored cell density, metabolic and product levels in continuous and batch fermentation.

Education

1996-04 - 1997-09 Master of Science: Biotechnology Worcester Polytechnic Institute - Worcester, MA

GPA: 4.0

1993-09 - 1996-03 Bachelor of Science: Biotechnology, Chemical Worcester Polytechnic Institute - Worcester, MA

GPA: 3.8

Accomplishments

Demonstrated history of successful end-to-end biologic and cell/gene therapy value generation, development, and commercialization, including contributions to the launches and production of the following products:

SHL – Complete transfer of six autoinjector products including commissioning of assembly and test equipment and creation of the process control strategy. Novartis – Kymriah CAR T, Xolair®, Simulect®, Ilaris®, and Cosentyx® Amgen – Epogen®, Enbrel® and Vectibix®.

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