Darren Gob Email & Phone Number

111 Consumers Drive. Whitby, On.

• Assist Commercial manufacturing with processing difficulties and quality issues to ensure compliance to regulatory standards and client regulatory submissions.• Write protocols, reports, and procedures to support activities for Tech transfer, product rework, process monitoring, process improvement, investigations, and Validation of new materials and equipment• Provide risk assessments for new materials, equipment, and processes for their suitability in commercial GMP manufacturing • Update Master Batch Records as required to accommodate CAPAs, client requests, and to improve operational efficiency via implementation of initiatives such as incorporation of the SOTAX tester, metal detector consolidation, new moisture balance, etc.• Interact with internal departments, other Patheon sites, and external clients on a daily basis to ensure adherence to timelines for project-related activities, commercial manufacturing schedules, and key performance indicators (KPIs).

2100 Syntex Court. Mississauga, On. L5N7K9

• Design formulations and manufacturing processes and execute trials to evaluate their performance.• Prepare technical reports outlining formulation/process development rationale, results, analysis, and recommendations for further improvements• Awarded with the company’s first full-time-equivalent contract as a lead formulation scientist due to significant contributions toward the development of a novel drug product. The contract generated an additional $1.5 million of annual revenue. • Alternate Qualified Person in Charge (AQPIC) for Controlled Substances

2100 Syntex Court. Mississauga, On. L5N 7K9

• Planned activities for the facility staff in the cleaning, calibration, and maintenance of department equipment. • Coordinated scheduling of Formulation Development manufacturing activities in both the FD Lab and the GMP Manufacturing facility.• Conducted audits to ensure that all activities in the lab complied with cGMP and Health & Safety Standards.• Wrote SOPs and assisted in the IQ/OQ/PQ for newly procured equipment.• Converted the non-GMP inventory tracking system from a paper system to an electronic system that automatically generated material codes, prompted the user when materials were about to expire, and when to reorder new material.

2100 Syntex Court. Mississauga, On. L5N 7K9.

• Executed experimental trials and manufactured clinical material for drugs in their developmental stages.• Manufacturing processes included topical manufacturing, wet granulation, compression, tablet coating, and encapsulation.

50 Steinway Blvd. Etobicoke, On.

• Manufactured solid dose drugs at the commercial scale. Processes included blending, dry granulation, pellet manufacturing, and flaking.

Pharmaceutical Manufacturing Technology

Bachelor Of Science (B.Sc.), Biochemistry