Brandon Foose Email & Phone Number

Remote

- Accountable for the Quality management of external suppliers' products, processes and related documents ~ Assure that the products supplied to patients are manufactured, tested in accordance with cGMPs, the registration file and any additional country specific requirements ~ Determine if product requirements (Quality Agreement, regulatory, or otherwise).

King Of Prussia, PA

· Build partnerships within and outside of compliance to define, implement and advance strategic initiatives that improve business unit core value drivers· Lead Third Party Oversight program liaising with Business Owners, Technical Subject Matter Experts, Procurement, Quality Assurance, and Third Parties (CMOs, CROs, Academic)~ Ensure deliverables met and.

Collegeville, Pennsylvania

· Lead and assist in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues internally and externally - Assessments of External Service Providers (national and foreign based) that are engaged in GLP work, supply of materials for GLP work and the analysis of.

Conshohocken, PA

· Champion Biopharm Product Development & Supply (BPDS) implementation of Internal Control Framework and Risk Management· Drive compliance and continuous improvement activities through evaluation of metrics, KPIs, and emerging trends at various levels (local business unit, department, etc.)· Coordinate department-wide Management Monitoring Program.

Conshohocken, PA

· Utilize strategic leadership and vision to maintain cGMP · Provide compliance oversight within Biopharm Product Development & Supply· Involved in extensive matrix working both internal and external ~ Working on deviation investigations, Root Cause Analysis, continuous improvements, data integrity, and 3rd party oversight· Ensure alignment of.

Conshohocken, PA

• Responsible for running cGMP samples on biochemical assays such as various ELISAs, qPCR, HPLC, SDS-Page, Caliper, and Total Protein Assays for release and in-process testing
• Provide bioanalytical support for biopharmaceutical products produced within Biopharm R&D
• Responsible for participating in assay qualification and tech transfer
• Adherence to standard operating procedures to maintain cGMP compliance Real time documentation in Electronic Notebook and LabWare/LIMS, maintain Critical Reagent Inventory
• Participate in the investigating of OOS and atypical results obtained during cGMP analytical testing
• Draft or revise analytical methods or SOPs in a cGMP documentation system

Collegeville, PA

• Lead and support timely and comprehensive investigations of Deviations and Customer Complaints - Lean Sigma White Belt (GSK Yellow Belt equivalent) and Business Lead Investigator trained for Deviation and CAPA.
• Identify most probable root cause – lead RCA meetings, populate TrackWise, and coordinate closure with Pre-Clinical QA
• Develop and support implementation of Corrective and Preventative Actions (CAPAs) to resolve gaps determined from quality investigations
• Compile metrics pertaining to quality issues/trends site wide and globally to identify and address gaps
• Own local Risk Register/Concerns Log and coordinate global meetings
• Represent Packaging Operations at site Tier 1 Quality council and across various other matrix team settings

Royersford, PA

• Collaborate with Biological Reagents and Assay Development group in the design and implementation of biochemical and cellular assays for large (HTS), small (focus screens), and continuous (compound profiling) screens.
• Present and report published data to program teams and engage in dialogue regarding lead optimization, MOA, Structure-Activity-Relationship, and in vivo and in vitro progress
• Develop and carry out assays for a novel approach to HTS, Encoded Library Technology DNA-tagged compound libraries are screened against protein targets and DNA is subsequently quantified through qPCR, amplified through.
• Techniques applied: qPCR, PCR, DNA sequencing, IC50, EC50, FLINT, FRET, IMAP, Fluorescent Polarization, absorbance, Scintillation Proximity assays, SDS Page protein gels, protein binding and affinity assays.
• Platforms competent in:Roche 454, Illumina, LightCycler 480, Fluorescence Plate Readers and Imagers (Envision, Viewlux, SpectraMax, Acquest, Analyst, etc.) SpotFire, thermo cyclers, liquid handling devices (Matrix.

• Performed stability and release assays for PCR diagnostic products (HBV, HIV, HPV, etc.)
• Conducted automated and manual PCR amplification and detectionManual – thermo cyclers (TC 9600 and 9700), Microwell plates, plate readers (light absorbency), etc. Automated - COBAS systems, ABI. Prism 7700 (real-time.
• Executed automated and manual RNA and DNA extraction techniques Manual – centrifuges, ultracentrifuges, heat blocks Automated – AmpliNAT MPX, GT-12, etc.
• Completion of batch sheets and entry into LIMs for validation; Adherence to GMPs, SOPs