Early Development Specialist Jobs

Lead protocol development of the new processes, batch record template set-up, set-up batch record management system, raw material inventory, etc.

A minimum of 6 years of industry experience genetic nanomedicine working with nanocarrier formulation and delivery.

Prior experience in non-viral delivery systems – formulation, process and analytics is essential.

Develop and harmonize scaled-up processes to enable single run of non-viral nanocarriers for RNA batch size of 10mg and beyond.

Work as a team member in development to build platforms that can provide material and information for tox studies,

Work as a team member in development working on CMC deliverable for various portfolio assets

Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Conducts site qualification, initiation, interim, and close-out visits

Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol

Travels to clinical study sites as required, including remote or onsite visits globally

Analytical problem-solving experience, trouble shooting and resourcefulness

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Relevant experience (minimum of 5 years; 8+ years preferred) in an academic, hospital, or pharmaceutical/biotech setting.

Strong scientific background in oncology drug development (basic, translational, and/or clinical); and experience in designing and/or conducting oncology clinical trails.

Experience leading a team in a cross-functional environment, preferably with global scope.

Strong collaboration, facilitative leadership, executive function, and problem-solving skills.

Excellent oral and written English communication skills.

4 years of experience in Electrical Design of large power plants or industrial facilities

Minimum of a bachelor's degree in a related field

Must be able to travel into the office 2x a week and 20% travel is required across the nation

Experience as an effective mentor. Line management experience highly preferred

Working with the Finance group to implement and track program budget.

Implement initiatives to support development and scaling of capabilities, tools and processes.

Collaboration with finance stakeholders to support tracking of actuals to budget, communicate deviations and identify variations;

12+ years’ industry experience, with deep experience managing early Clinical Development projects in pharmaceutical or Biotech Company

Experience of drug development in oncology strongly preferred

Knowledge, Skills, Abilities, and Competencies

Job Posting End Date (Continuous if Blank)

Estimated Appointment End Date (Continuous if Blank)

Position is located at Oklahoma School for the Deaf in Sulphur.

Current State of Oklahoma employees

with permanent status in state service, must apply through the Workday on-line