Daniel Dry Email & Phone Number

Pennsylvania, United States

Exton, PA

Upstream Operations, Biologics Pilot Plant- Lead upstream campaigns teams for clinical manufacturing of monoclonal antibodies under cGMPs.- Responsibilities include scheduling and planning, process and equipment training, batch execution / closure, and deviation resolution / CAPA implementation.- Equipment expertise includes stainless and disposable.

Malvern, PA

- Led completion of BLA process description and process validation sections covering all API manufacturing stages from preculture through formulated bulk fill. Authored and reviewed section granules and supporting process validation documents.- Coordinated, performed, and supervised lab-scale bioreactor studies to support several products from early stage.

Spring House, PA

- Led transfer of CHO mAb preculture and fed-batch bioreactor processes to 1000-L disposable bioreactors for pre-clinical scale-up evaluation and reference standard manufacture.- Executed 250-L perfusion bioreactor process of Sp2/0 myeloma to support Phase III technology transfer.- Trained upstream lab-scale scientists in 1000-L disposable bioreactor.

Malvern, PA

- Acted as operations team member for site planning and equipment commissioning, during construction and start-up of cGMP pilot plant.- Provided technical and execution support for equipment and utility IQ/OQ/PQ. Executed and reviewed validation protocols and reports.- Manufactured recombinant proteins in E. coli under cGMPs at 400-L scale, including all.

Malvern, PA

- Performed small-scale microbial fermentation, recovery, refolding, DSP, and in-process analytical methods.- Supported site-transfer of a commercial process to CMO, including client review of technology transfer documents, batch records and SOPs. Acted as Person-in-Plant for cGMP campaigns. - Trained and qualified CMO QC analysts on key and sensitive.

King Of Prussia, PA