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Direct Hire - Sr. Principal Process Associate
Ref No.: 18-26804
Location: Exton, Pennsylvania
Job Description
Provide hands-on support and/or some leadership in the operation of equipment to support preclinical, phase I and phase II clinical trials. Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.

Provide support and/or some coordination effort for the transfer of new processes and technologies for media, buffer and excipient preparation working with R&D and the technology transfer laboratory personnel. Support process performance monitoring, operational excellence activities, and process improvement strategies.

Leads in the qualification/validation program for Pilot Plant equipment/systems by supporting all commissioning, initial testing, requalification, and validation maintenance activities. Following startup, participate or lead in the design, implementation and commissioning of new technologies for Support Operations. Participation in other areas within the facility may be added at the company’s discretion.

Lead preparation of bill of materials, media/buffer batch records, SOPs, and close-out reports for each campaign.

Lead in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.

Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines.

Interact cross-functionally with Downstream Operations, Upstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development.

Provide lead support and cross-training during production campaigns.

Job Qualifications
Minimum of 7-10 years progressive experience in a multi-discipline cGMP manufacturing environment, running processes and equipment in Support production areas.

Proficient in weigh, dispense, and sampling procedures for controlled raw materials

Proficient in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutions.

Knowledgeable in technology transfer, equipment validation and facility startup.

Ability to identify, investigate, and resolve basic process and equipment problems.

Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulations.

Must be willing to work any shift in supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required.

Must be able to sit and/or stand for extended periods of time and be able to lift 25 lbs.

Self starter with a strong focus on detail, safety, quality and results.

Strong written and verbal communication skills.

Good problem solving and interpersonal skills with the ability to work and lead others in a small team environment required.