Summary: The Process Development Technician III is responsible for laboratory testing for the product monitoring process, in-process analytical testing, equipment performance and maintenance, assisting in process verification/ validation and executing development initiatives using laboratory and processing equipment in lab production scale-up environments for the Upstream, Downstream, or Virology groups.
- Operation of laboratory equipment to demonstrate the ability of the product/device to function as intended in a product/process development environment.
- Monitor the performance of processes and equipment and make recommendations for continuous improvement.
- Ensure that all documentation necessary for studies are in accordance with company guidelines.
- Work with in-house manufacturing team members to scale-up, validate and transfer to commercial manufacturing process.
- Assist in trouble shooting of scale-up problems and develop solutions.
- Ensure inventory levels for all items in the lab are at adequate levels.
- Develop and/or review SOP’s and assist with drafting batch production records (BPR’s).
- Develop and execute protocols for the specific process (e.g., Upstream, Downstream, or Virology).
- All other duties as assigned.
Required Skills & Abilities:
- Experience using viruses in a vaccine development environment.
- Experience working in a development environment to support vaccine development programs.
- Experience monitoring the performance of laboratory processes and equipment.
- Ability to work independently and within a team under minimal supervision.
- Ability to provide observations within a developing process.
- Strong attention to detail.
- Excellent verbal, written and organizational skills.
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint).
- Strong organizational and analytical skills.
- Strong interpersonal and leadership skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- May be required to lift up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
- Master’s degree preferably in a Science related field with 1 year experience executing studies and performing laboratory testing; OR
- Bachelor’s degree preferably in a Science related field with 2 years’ experience executing studies and performing laboratory testing.
- Experience working in a cGMP (current good manufacturing practices) facility.