Role Title: Director of Manufacturing

Department: Manufacturing

Supervisor: COO and CEO

FLSA: Exempt

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

ROLE SUMMARY

The MSAT Senior Process Engineer (Upstream), under minimal supervision, is responsible for overseeing the development, transfer, validation, and troubleshooting of Polaris’ bio-pharmaceutical processes as well as other process of potential CDMO projects. The MSAT engineer is expected to serve as a Subject Matter Expert (SME) for a wide variety of process steps and equipment, with emphasis on Upstream manufacutring. Experience with process development, technology transfer, process validation, and cGMP bio-manufacturing are highly desired. Ability to plan, coordinate, and execute large-scale projects related to the manufacturing process is required. As part of the MSAT group, the Engineer must have a strong understanding of Upstream manufacturing processes to assist with process development and technology transfer. Ability to assist with/support routine manufacturing activities may be required.

ROLE RESPONSIBILITIES

• Serve as the bio-process Subject Matter Expert (SME) on multi-disciplinary project teams
• Use FMEA or other risk-based approaches to assess process performance
• Use Quality by Design (QbD) principles to design and execute scaled-down process experiments to increase process knowledge and prepare for process transfer/validation
• Perform process characterization studies using methods such as Design of Experiments (DOE)
• Perform technology transfer of processes from small scale to clinical/commercial GMP scale
• Provide input into the design and procurement of process equipment, including development of URS documents and review of design documents
• Provide input into the validation of facilities, utilities, and equipment to ensure they meet the requirements of the process
• Oversee upstream process validation, including development of process validation protocols and reports
• Author, review, and execute FAT, SAT, IQ, OQ, and other commissioning/qualification protocols as necessary
• Assist with development and execution of the product changeover program
• Assist manufacturing management with development of production schedules, changeover schedules, or project schedules
• Participate in manufacturing activities as needed by the manufacturing department
• Create URS documents for manufacturing equipment based on process requirements
• Draft and execute PQ protocols for manufacturing equipment and utilities
• Interpret system performance data
• Review and draft risk assessment reports
• Perform GAP assessments related to the manufacturing process
• Provide technical assistance with Upstream manufacturing processes including E.coli fermentation, cell lysis, cell separation, media preparation, and filtration
• Don cleanroom attire such as coveralls, frocks, and boot covers and enter cleanroom areas as required
• Serve as the the Upstream process SME in compliance audits
• Assist the production team with deviations, change controls, and process improvement activities

SKILLS

• Subject Matter Expert (SME) level understanding of Upstream cGMP recombinant protein manufacturing techniques, including fermentation/cell culture, cell separation, cell lysis, and media preparation.
• Familiarity with Downstream processing techniques such as column chromatography and TFF
• Familiarity with analytical techniques used to evaluate the quality, identity, purity, and safety of bio-pharmaceutical products
• Strong understanding of cGMP quality systems and documentation, including deviation investigation, change control, batch production records, and SOPs
• Ability to gain knowledge of new processes quickly and understand how they can be implemented at small or large scale
• Experience designing and performing process development/characterization experiments, using either One Factor At a Time (OFAT) or Design of Experiments (DOE) with software like JMP or Minitab, etc., approaches
• Ability to communicate highly technical scientific data to a diverse audience
• Ability to independently lead project initiatives related to process development, technology transfer, process validation, cleaning validation, or process improvement
• Ability to create and maintain strong working relationships with vendors to support the manufacturing process
• Knowledge of facility, utility, and equipment validation procedures, such as IQ, OQ, and PQ
• Knowledge of regulatory requirements for cGMP manufacturing of bio-pharmaceuticals
• Strong technical writing skills
• Good record keeping, organizational, written, and verbal communication skills
• Knowledge of concepts of large-scale, automated production equipment, including: PLCs, P&IDs, Control Loops, Calibration, SCADA, PID Control, and Cascade Control

QUALIFICATIONS

B. S./B. A. in Engineering/Science Related Field. 8-12 years of relevant cGMP experience is desired.

MS Degree in Engineering/Science Related Field. 5-9 years of relevant cGMP experience is desired.

PhD in Engineering/Science Related Field. 3-6 years of relevant cGMP experience is desired.