The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help cancer patients.

Primary Responsibilities:

• Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
• Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records.
• Collect data for process qualification and implementation.
• Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
• Support process optimization, development of new processes, and introduction of new technologies.
• Lead equipment qualifications and improvement projects. Support the execution of process validations.
• Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house.
• Provide guidance, support, training, and knowledge to Production team.

Expanded Responsibilities:

• Take a leadership role in managing multiple projects.
• Work with other employees on the Production and Quality teams.
• Coordinate internal resources and third parties.
• Supervise work of contractors.
• Create/maintain comprehensive project documentation. Work with Quality Unit to ensure readiness for inspections.
• Ensure that all activities are in compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
• Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
• Support cross-functional teams to address all site-related activities, such as urgent events that regulations, and Orano Med Policies.
• Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
• Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.

• Competitive compensation
• Health, Dental, and Vision insurance - with generous employer contributions
• 401(k) with employer matching and contribution amounts

• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

• and more...

All candidates must meet the following minimum requirements to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Qualifications:

• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, or Chemistry.
• 3 years experience in a process support or development role in GMP manufacturing and/or QA/QC.
• Previous experience with qualifying instruments and processes in a new manufacturing facility.
• Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.
• Proficient in technical writing.
• At ease with following detailed SOPs and completing extensive detailed documentation (e.g., batch records) and patiently revising documentation following QA review.
• Attendance of production up to 50%. Typical production shift will be approximately: 3:00 PM to 12:00 AM. Ability to work overtime, weekends, and off shifts, as needed.
• Knowledgeable on PPE: safety glasses/goggles, hair net, mask, gloves, appropriate shoes, and scrubs under a lab coat or Tyvek suit.
• Ability to safely lift 50 pounds.