The Manager is the area owner of the downstream process suites and direct line manager to multiple staff members, including supervisors. The Bothell manufacturing group is charged with advancing the pipeline by producing drug substance for early to mid-stage clinical candidates.
This position will be part of the Global Manufacturing and Supply organization.
Key responsibilities include:
Managing staff by setting objectives, creating development plans and completing performance reviews.
Arranging work assignments and required support to meet schedules and resolve conflicts.
Providing oversight of cGMP manufacturing operations, and verifying procedural and safety compliance.
Reviewing and approving documents including Standard Operating Procedures (SOP), Master Batch Records (MBR), and equipment qualification/validation documentation.
Reviewing executed MBRs and serving as area supervisor for the review and approval of investigations and corrective actions; may also lead investigations and corrective actions as needed.
Serving as a key interface with supporting groups such as Bioprocess Development, Quality Assurance, Quality Control, Manufacturing Technical Services, etc.
Representing the downstream operations during internal or external audits.
Defining equipment and capital purchasing needs for the downstream area and may lead operational (OpEx) improvement projects.
Position requires occasional work on nights, weekends, and holidays.
• BS degree in science, engineering or biochemistry with 10 years relevant experience in the biotechnology industry.
• Experience in clinical and/or commercial-scale production operations subject to Current Good Manufacturing Practices (cGMP) regulations.
• Previous supervisory experience is preferred.
• Expertise in purification processes is essential (i.e. column packing, chromatography skid preparation/operation, TFF/UFDF preparation/operation, etc). Additional experience in cell culture, fermentation and recovery processes is a plus.
• Current understanding and application of best practices related to process hygiene/microbial control, equipment cleaning, and change-over procedures.
• Solid background in equipment qualification (i.e. set-up and execution of installation/operational/performance protocols (IQ/OQ/PQ); qualification lead experience a plus.
• Hands-on experience with disposable/single-use technology is essential.
• Demonstrated success participating in/managing technology transfers of new processes into a cGMP manufacturing facility.
• Demonstrated leadership and interpersonal skills; is attentive and approachable.
• Excellent organization and communication skills, both written and verbal.
• Ability to lift at least 25lbs.
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