Sr Director/VP Biotech Professional

Beverly Lynn Wolgast

858-***-**** *******.*******@*****.*** https://www.linkedin.com/in/beverly1wolgast/

Ph.D. in Synthetic Organic Chemistry from Brandeis with Harvard Post-doctoral work and 20 years’ experience with focus on Chemical Biology. SME Quality Assurance, Quality Control, ICH 7, cGMP, ISO 9001, ISO 13485, API, CDMO, SOPs, MSAT, CMC, QMS, stability protocols, deviations, process improvements, WI’s, OOS, procedures, regulatory reports. Experienced with Analytical, Bioanalytical, CMC, MSAT, Formulation, and more. Proven leader, director, advisor, facilitator for solving chemical and biological problems from discovery to manufacturing. Competent in wide and in-depth operations in pharmaceutical products and extensive project management.

Core Competencies

Quality Assurance Quality Control MSAT Bioanalytical CMC

Synthetic Organic Chemistry Medicinal and Process Chemistry

Professional Experience

Applied DNA Sciences 09/23 – 09/24

Stony Brook, New York

Executive Director, Quality Assurance, and cGMP Manufacturing Operations

Enhanced Quality Operations for on-going business and LineaRx IVT Vaccine Template applications.

Scale Up Linea IVT Templates of Vaccine segment for customer applications. QMS. Inputs/Outputs.

Modeling of future needs and implementation of Quality Aspects for programs. Bioconjugation.

Gap assessment for site capacity for scaleup and ISO 13485 implementation. Peptide Chemistry.

CDMO contact for Oligonucleotide Synthesis. Audit Programs. Deviations. Complaint Handling.

Technical Report implementation for Enzyme equivalence, Sterilization, Fragment Analyzer, etc.

Improved timelines > 4X and decrease dsRNA 100X relative to plasmids.

TriLink Biotechnologies Division of Maravai Lifesciences 07/22 – 02/23

San Diego, California

Director, cGMP Manufacturing Operations

Performed Nucleotide Triphosphate analog synthesis for mRNA Application. Oligonucleotide Synthesis.

Focus on Quality Assurance, OOS, Deviations, Deviations, Process Improvements, regulatory.

Scale Up of BIONTECH/PFIZER mRNA Vaccine segment for SARS-COV-2. GxP. AKTA Synthesizers.

Hipersep Purification. Vanquish UHPLC control and QC. Project Management. QMS. Deviations.

Edited and streamlined Documents. IQOQ. PM. ISO 13485. ISO 9001:2015. QC, QA, QV.

Transfer operations due to expansion and increase in needs to nearby site. Peptide Chemistry.

Operations on a 24/7 basis with 12-hour shifts. 48 reports.

Biocept, Inc, San Diego, California 05/19 – 5/22

Senior Director, Manufacturing, Quality Control, and Facilities Operations

Responsible for all laboratory, personnel, SOP’s, ST’s, WI’s, IP’s, Quality Control, Quality Assurance, Manufacturing Products. cGMP, GxP, ICH, CAPA, FDA inspections. ISO 9001:2015, ISO 13485 preparation, 21 CFR Part 211 and 820. Project Management. Bioconjugation of AlexaFluors. Peptide Chemistry.

Saved $3.5M by purchasing COVID-19 Kits from China. Clinical Dev Ops.

Conceived and implemented SARS-COV-2 testing which increased revenues 10X.

Date extended CSF Tubes from 3 months to 18 months through gamma radiation sterilization.

Outsourced Contract Manufacturing of Blood Collection Stability and CSF Tubes in China.

Wrote, edited streamlined numerous Biocept Documents. IQOQ. PM.

Supervised all Biocept Flow Cytometry, Immunochemistry, HPLC, QC and Molecular production. Aseptic cell culture. Aseptic solutions.

CDMO contact for Oligonucleotide Synthesis. Audits. QMS. Deviations. CAPAs.

Chemical Hygiene maintenance and upkeep throughout facility. EH&S Functions.

QC of incoming antibodies and outgoing antibodies and immunoconjugates.

Report writing, presentations. Warehouse and outsource work. GMP Compliant documents.

Production laboratory and scale-up support – link between R and D and clinical development ops.

Made recommendations for equipment and more effective operations. 45 reports.

Designer Molecules, Inc, San Diego, California 06/18 – 04/19

Quality Assurance Manager (Lead) – Quality Control

Responsible for all laboratory, personnel, SOP’s, ISO 9001:2015 Representative & Documentation.

Quality specifications and tests. GxP Compliant. Quality Control, Quality Assurance.

Equipment calibration, maintenance, upkeep, records, training. Project Management.

TGA, DSC, Viscometry, FTIR, GPC, HPLC, SEC-MALS, ICP-OES, TMA, DMA; QC/QA.

Made films and testing parameters on silicon wafers.

Diomics, Inc, San Diego, California 02/14 – 06/18

Chief Operating Officer

Provided all laboratory, personnel, and vendor operations. Assisted Patent lawyers with Patent Application and Prosecution. Quality Control. Quality Assurance. Manufacturing. R and D. Scientific direction, assisting with business development and marketing. Peptide Chemistry.

Extensive GLP, GMP, GxP, Quality Control, Quality Assurance, IQOQ, PM, and SOP documentation. Project Management. ISO 9001:2015, ISO 13485 preparation, 21 CFR Part 211.

Discovered Method to make Hydrophilic Thin Films which enable fingerprint identification and pick-up and release of DNA from those fingerprints at > 80% assay and full CODIS alleles.

Determined Method for manufacturing of swabs which pick up and release blood DNA at > 80%.

Discovered Method for complete dissolution of swabs, films, and cards. Clinical dev ops.

Methods including qPCR, UV-Vis, Fluorescence Spectroscopy, Flow Cytometry, ADC.

Co-authored four patent families; assisted with granting of 11 patents and 11 pending patents.

Education

Post-Doctoral Fellow

Harvard University, Cambridge, Massachusetts

Monolayers on gold; Thin Films; Sputtering; Photochemistry; Synthesis of Alkylmercaptans

Doctor of Philosophy (Ph.D.) Organic Chemistry

Brandeis University, Waltham, Massachusetts

Intramolecular Alkenyl-allene Diels Alder Reactions; [2+2] Cycloadditon Reactions

Bachelor of Science (B.S.) Chemistry

Rensselaer Polytechnic Institute, Troy, New York

Minors in Molecular Biology and Business

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