Director, GMP Facilities

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

In support of these efforts, we are seeking a dynamic and agile Director, GMP Facilities, to provide strategic and operational leadership for our GMP manufacturing site in Germantown, Maryland. Key accountabilities include: ensuring that the GMP facility and equipment comply with regulatory requirements for late stage clinical / commercial GMP manufacture of biopharmaceuticals, managing relationships with contract service providers, working cooperatively with manufacturing and metrology personnel, and driving continuous improvement.

This is an onsite role in our Germantown facility with an estimated travel commitment of 10%.

DUTIES AND RESPONSIBILITIES:

• Provide leadership and vision in developing GMP facility management strategies across Precigen’s internal manufacturing site.
• Provide expertise and guidance in commissioning new GMP manufacturing and QC laboratory space, as well as equipment/building management system(s.)
• Lead a cross-disciplinary team in preparation of the GMP facility for regulatory inspection
• Implement an effective clean room operation, including effective cleaning, HVAC and environmental monitoring, preventative maintenance, and all other sustaining activities of a cleanroom.
• Work with outside contractors to ensure that the GMP facility adheres to industry standards.
• Lead projects that span across the manufacturing, metrology, and facilities groups to assure compliance with quality standards.
• Oversee preventive maintenance program for GMP equipment, as well as GMP building management systems
• Coordinate work assignments among building technicians, vendors, and contractors to ensure assignments are completed on time and within budget.
• Develop and report on key maintenance metrics that drive continuous improvement within the GMP facilities organization.
• Investigate, troubleshoot, and resolve problems that occur during routine operations related to facilities, engineering, and manufacturing.
• Project manage cGMP facility shutdowns aligning key stakeholders and ensuring successful return to production.
• Oversee utility and building management systems that support the GMP manufacturing area.
• Author procedures, policies and regulatory audit responses.
• Support GMP facility budgeting and resource prioritization.
• Engage with third parties for shipping, logistics, and off-site storage needs.

EDUCATION AND EXPERIENCE:

• BS in Engineering or a related area required; Master’s degree preferred.
• Minimum of eight (8) years of progressive management experience with at least six (6) years of directly applicable experience in GMP facilities, building operations, cleanroom operations, and project management in a /biotech/pharma organization or equivalent.
• Understanding of cGMPs and operation of a biotech/pharma manufacturing facility.
• Experience with HVAC, electrical, plumbing, equipment predictive/preventative maintenance and emergency power systems.
• Knowledge of and ability to read building schematics and blueprints.
• Hands on experience in working with quality systems, including change/deviation management as well as implementation of CAPAs.
• Ability to use all building management software, standard office software, security camera system software, and floorplan software.
• Experience with GMP facility commissioning and preparation for regulatory inspection
• Exceptional organizational skills and attention to detail required.
• Acumen for teaching/training and excellent communications and supervisory skills required.
• Basic technical writing proficiency required.

DESIRED KEY COMPETENCIES:

• Highly organized with strong personal leadership and self-direction.
• Well-developed interpersonal skills and demonstrated ability to work with and coordinate demands from multiple customers, both internally and with partners.
• Demonstrated attention to detail and ability to effectively manage own projects and priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Ability to understand and execute on the company’s mission and values.
• Clear communication in both oral and written form.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Ability to safely lift up to 30 pounds.

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

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