Senior Principal Process Associate, Support Operations
Under minimal supervision, the Senior Principal Process Associate, Support Operations will be responsible for performing diverse functions from the qualification/validation of equipment to the planning, coordination and routine operation of equipment and production suites in a cGMP biopharmaceutical pilot plant. The Senior Principal Process Associate will lead the preparation of media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation of process equipment using a washer and autoclave. The incumbent will provide major technical expertise and is responsible for functions supporting the manufacture of preclinical, phase I and phase II clinical materials, including leading the incorporation of new technologies/processes, operations and troubleshooting of equipment, preparation and close-out of documentation, and ensuring compliance to relevant regulations.
The Senior Principal Process Associate will also lead the identification, evaluation and implementation of process improvement strategies and evaluation of new technologies for Support Operations and/or Validation projects. Additionally, this individual will support Change Control and (re)qualification related testing for all equipment/systems, and supports Validation protocol development (IQ, OQ, PQ), execution, assessments, data reviewing specifications, procedures, protocols and final reports preparation. This individual may lead a team supporting a production campaign and will work effectively in cross-functional project teams as well as independently to accomplish project goals. Training and cross-training for new/existing staff is required on an as needed.
Responsibilities include but are not limited to:
1. Providing hands-on support and/or some leadership in the operation of equipment to support preclinical, phase I and phase II clinical trials.
2. Coordinating equipment maintenance, calibration, and validation with appropriate internal departments.
3. Providing 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. Supporting process performance monitoring, operational excellence activities, and process improvement strategies.
4. Leading in the qualification/validation program for Pilot Plant equipment/systems by supporting all commissioning, initial testing, requalification, and validation maintenance activities. Following startup, participating or leading in the design, implementation and commissioning of new technologies for Support Operations; Participating in other areas within the facility may be added at the company’s discretion.
4. Leading preparation of bill of materials, media/buffer batch records, SOPs, and close-out reports for each campaign.
5. Leading in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.
6. Ensuring adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines.
7. Interacting 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.
8. Providing lead support and cross-training during production campaigns.
• BS or MS in Biological Sciences, Engineering or equivalent job experience/degree is strongly preferred.
• 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.
Source: Job Diva – Job Listing