Joseph Fackler Email & Phone Number

United States

Washington, Dc, Us

• Led US team in upstream and downstream process development studies, providing technical, tactical, and scientific leadership• Designed and executed studies using Design of Experiment (DOE) approach for screening propagation conditions and growth media comparisons• Supervised setup of a parallel bioreactor system and performed pilot test runs with investigational product• Led Tangential Flow and Filtration (TFF) studies for purification of drug substance

Gaithersburg, Maryland, Us

In my role, I successfully managed three distinct groups/teams: Process and Analytical Team, Phage Hunting Laboratory (drug discovery), and Clinical Testing Laboratory.• Oversaw initial process scale up to Single Use Bioreactors (SUB) and led Tangential Flow and Filtration (TFF) optimization studies for a diverse group of phages and host bacterial species• Led development, optimization and qualification of analytical methods including: Viral Plaque Assay (VPA), LC-MS/MS platform for Host Cell Protein (HCP) and bacterial cell based Phage Susceptibility Tests (PST)• Directed establishment of a clinical testing laboratory to screen and match a subject’s isolate(s) for clinical trials

Gaithersburg, Maryland, Us

• Built and led a team of microbiologists/manufacturing technicians to manufacture batches of bacteriophage Drug Product for Phase II clinical trials• Supported batch disposition and batch release for multiple lots of Drug Product• Supported regulatory filings by authoring the CMC section of APT’s Master File• Participated in Type B meeting with the FDA as the CMC expert for APT's phage bank product

Gaithersburg, Maryland, Us

• Led team of microbiologists/manufacturing technicians to manufacture bacterial cell and bacteriophage seed banks for Phase II UTI clinical trial• Screened, identified, and manufactured banks of drug product under GMP conditions for compassionate use cases• Managed external communications with public and private partners in support of compassionate use cases

Gaithersburg, Maryland, Us

• Collaborated with the US military partners to screen bacteriophages for activity against bacteria using Phage Susceptibility Test (PST)• Authored Standard Operating Procedures (SOPs) and batch production records to standardize manufacturing, reducing drug substance turnaround time by ~50%• Contributed to compassionate use cases by improving efficiency and effectiveness in drug development

Cincinnati, Ohio, Us

Lead analyst in GLP/GMP compliant evaluations of antimicrobials and medical device reprocessing method validations. Experienced with BSL 2 microorganisms including Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), Legionella spp. and Clostridium difficile endospores. Performed product and method validations on new molecular pathogen detection technologies.

Indianapolis, In, Us

Cincinnati, Ohio, Us

Instructor for General Microbiology Laboratory, Microbiology for Health Professionals and Sophomore Genetic laboratory courses. Responsible for Laboratory instruction and supervision of laboratory techniques in microbiology, molecular biology and genetics such as: aseptic technique, isolation streaking, spread plating, environmental sampling, DNA isolation, transformation, PCR, Gel electrophoresis, bacterial identification, enzyme isolation and enzyme kinetics.

Cincinnati, Ohio, Us

Instructor for General Microbiology Laboratory and Microbiology for Health Professionals

Cincinnati, Ohio, Us

Supported laboratory staff by maintaining glassware, sterilizing laboratory materials and preparation of standard and specialized media.

Master Of Science (Ms), Microbiology

Bachelor Of Science (B.S.), Biology