Stephanie Saddic Email & Phone Number

Chester Springs, PA, US

King Of Prussia, Pennsylvania, United States

• Acquisition of Gyroscope Therapeutics by Novartis for $1.5B
• Lead large and complex CMC matrix team for drug development and late-stage strategy ophthalmic AAV gene therapy program.
• Coordinate all tech transfer activities of AAV suspension manufacturing process from a CDMO to internal manufacturing and testing capabilities
• Present program strategy, timelines,budget forecasts and resource requirements at all internal global project team meetings and governance

King Of Prussia, Pennsylvania, United States

• Acted as a single point of contact between process development, analytical, device development, quality, regulatory, clinical operations, and clinical development teams in Gyroscope and several CMOs
• Hired and managed US team responsible for all GMP activities including manufacturing and release of plasmids and viral vectors, secondary packaging, labeling, release, and distribution of clinical trial supply for.
• Directed CDMO vector manufacturers and as served as person-in-plant (PIP) during manufacturing campaigns, investigations and overall program management delivering GMP batches for the clinic.
• Composed presentations for multiple governance boards and partnered with the project teams highlighting key deliverables and challenges to ensure alignment with clinical timelines.
• Established clinical trial supply kit design and packaging, labeling, QP release, and distribution to 9 countries to 50+ clinical sites to delivering IMP and devices to patients in on-going clinical trials.

Collegeville, Pennsylvania, United States

• Developed and presented the lentiviral vector and cell therapy analytical strategy, risks, and resource requirements to senior leadership and governance boards
• Hired and managed an US Quality Control Team that aided in batch release and stability for critical reagents, reference materials, raw materials, cell banks, drug substances, and drug products at CMOs.
• Coordinated with Analytical Development to ensure that method development, equipment, and processes enable the successful transfer of fit-for-purpose vector and cell methods internally and to CDMOs.
• Authored and/or reviewed analytical data, technical documents, and modules for regulatory submissions (IND, IMPD, scientific advice, briefing documents)
• Implemented quality control processes and documents to support product development internally and at CDMOs which allowed the release of product for compassionate use patients

Upper Merion, Pennsylvania, United States

• Directed CMC team and all CMC activities for a commercially approved program by presenting strategy, timelines and data at internal governance technical and supply boards.
• Expanded supply chain and analytical testing across multiple sites including scale-up and tech transfer of drug substance, drug product manufacturing and testing from CMO to internal capabilities.
• Delivered complex US supply of strictly government regulated contract (BARDA) which required replenishment of strategic national stockpiles (SNS) to always maintain supply.
• Authored and reviewed regulatory documents for Prior Approval Supplements (PAS) and MAA

Upper Merion, Pennsylvania, United States

CMC analytical matrix team member for multiple monoclonal antibody programs (Preclinical to Commercial)

Upper Merion, Pennsylvania, United States

Performed biochemistry testing in commercial monoclonal antibody manufacturing facility.

Malvern, Pennsylvania, United States

Performed biochemistry and microbiology testing on monoclonal antibody samples in commercial manufacturing facility.

Malvern, Pennsylvania, United States

Tested, scheduled and provided client support in GMP/GLP mycoplasma laboratory

Executive Mba

Executive MBA in progress

Bachelor Of Science - Bs, Biology