Craig Oakum Email & Phone Number

Cranbury, New Jersey, United States

Established analytical laboratory for startup CDMO in support of analysis of incoming raw materials, work-in-process, finished goods, and development. Managed daily activities, including incoming samples, scheduling resources, prepared and reviewed of CoA's or analytical reports, and oversight of infrastructure (equipment calibrations, maintenance of reference standards, consumables, etc.), to ensure that routine and non-routine experiments are properly executed to ensure accuracy and validity. Responsible for development and engagement of team of analytical scientists with regular performance review and feedback.• Established new analytical laboratory through: o Selected laboratory instruments for procurement, coordinated installation and qualification, and authored SOPs and forms for their use.o Authored critical SOPs for governance of analytical laboratory.o Hired scientists and trained and mentored them.o Created process for incoming samples tested either internally or via external laboratories.o Reviewed and released analytical data, reports, and CoA's.o Introduced and led new analytical methodologies per client project requirements.o Relocated laboratory to an expanded site that included management of change control and requalification.• Interfaced with project management and other functional group leads to prioritize weekly goals and lab schedule in support of project deliverables and operations schedule.• Established process for cleaning verification of manufacturing equipment to minimize equipment downtime.• Represented Analytical in internal and customer meetings to present data, update on project status, and identify new project requirements.• Selected and managed external laboratories for analytical and microbiological testing that could not be supported internally.• Investigated and corrected OOS results, internal and external audit observations, and applicable quality deviations and developed effective corrective and preventative actions.

Cranbury, New Jersey, United States

Interim Environmental, Health, and Safety (EH&S) Coordinator for multi-site CDMO overseeing safety of manufacturing operations, warehouse, and analytical laboratory. Managed EH&S observations and action items, training, and establishment of improved processes.• Established annual HAZWOPER training for 24-hour technician and 8-hour first responder certifications.• Site-wide fire extinguisher training.• Selected and established training for First Aid and AED Team.• Conducted monthly safety meetings to address previous months’ observations and corrective actions.• Training for responsible people for Hazmat, RCRA, IOTA requirements.• Set up site-wide Prescription Safety glasses program.• Established safety program at new site including monthly inspections, emergency response plan, first aid and AED.• Conducted routine safety inspections of hazardous waste and coordinated destruction by qualified vendors.• Updated existing and authored new SOPs to meet EH&S requirements.

Cranbury, Nj

QC Manager for establishment of a new Quality Management System for startup CDMO that included an SOP system, inspections, product disposition labeling that was later successfully updated to comply with ISO 13485 and DEA licensing requirements.• Contributed to establishment of Quality Management System (QMS) through authoring new SOPs for Quality Assurance and Quality Control• Managed ISO 13485 site certification including gap assessment of current to ISO 13485 standard, author of new and revised SOPs to align with ISO 13485, oversight of other functional groups’ improvements, all of which resulted in a successful ISO 13485 certification on the first audit.• Contributed to a successful application for site DEA manufacturing license on the first inspection through authoring new and revised SOPs and managed the change control to complete the project in 1 month.• Established team for Quality Control (QC) inspection and sampling for incoming raw materials, work-in-process, and finished goods according to Acceptable Quality Limit (AQL) techniques.• Supported Client and Internal audits by recording questions and meeting minutes that were used to complete audit responses.• Authored and maintained interim Microsoft Access databases for Quality Management Systems pending selection of commercial Quality Management Systems. Databases included SOP and training management, metrology, and reference standards.

Ewing Nj

Formerly MicroDose TherapeutxJul 2012–Aug 2018Analytical R&D Group Leader / Supervisor, Teva Pharmaceuticals (Formerly MicroDose Therapeutx)Team leader for analytical development of drug/device combination products. Oversee lab activities to ensure that experiments are properly executed to ensure accuracy and validity.• Interfaced with project management to align weekly goals and lab schedule in development of a Phase 1/Phase 2 ready inhaler.• Authored SOP’s and CAPA’s that resulted in ISO certification.• Spearhead lab operations by ensuring that support activities are completed in a timely manner.• Author and maintain Microsoft Access databases for laboratory activities including metrology, reference standards, drug product development, equipment use, and lab safety labels that that streamlined lab operations for efficiency.Sep 2007–Jul 2012Scientist II, MicroDose TherapeutxLead scientist on feasibility studies for investigational new drug applications in proprietary Phase 1/Phase 2 dry powder inhaler technology.• Characterized pharmaceutical development projects for aerodynamic particle size distribution via Next Generation Impactor (NGI), delivered dose uniformity, and simulated breathing studies.• Optimized design of single-dose and multi-dose dry powder inhaler with engineering team through design of experiment (DOE) studies that enabled in several clinical trials.• Developed a simulated clinical dosing system to measure effects of breathing through a dry powder inhaler that resulted in adjustments to the inhaler’s design reducing negative effects on performance.• Trained clinical staff on use of proprietary dry powder inhaler and attended multiple clinical trials as technical support to ensure successful execution with new Phase 1 inhaler technology.• Crafted study materials for clinical trials including drug, user instruction manuals, and supplies.• Authored SOPs and Equipment Procedures for analytical methods used in studies.

Cherry Hill, Nj

QC Chemist for sterile injectable manufacturingPerformed quality tests on finished sterile injectable product, commercial stability, validation, and raw material samples. Tests included assays for active pharmaceutical ingredients, related substances and preservatives by HPLC or GC, oxygen headspace testing by GC, identification by thin layer chromatography, infrared analysis or UV/Vis spectrometry, trace metal presence by atomic absorbance, pH and osmolality measurement, various titration assays, and other miscellaneous tests.• Maintained reference standards (physical and database inventories) as necessary and performed cost analysis that resulted in reduced consumption and increased savings.• Conducted laboratory investigation protocol testing.• Wrote SOPs and test methods and trained other chemists on changes and new procedures and techniques.• Monitored work from other shifts and performed troubleshooting of software and instruments as necessary.