Scientist/Engineer, Drug Product Process Development

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.

We are seeking an experienced Scientist/Engineer, Drug Product Process Development at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative Gene Therapies. This position will require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will be supporting all CMC aspects of late stage to commercialization of adenovector products.

DUTIES AND RESPONSIBILITIES:

• Design and execute representative lab-scale experiments to characterize Drug Product fill-finish process and the final Drug Product, including degradation pathways, storage, and clinical and commercial in-use conditions of adenovector products.
• The individual will design and refine the Drug Product Process from freeze/thaw through filling and inspection and will be responsible for industrialization, troubleshooting, and support validation of Drug Product.
• Provide technical support towards GMP manufacturing, engineering, and validation campaigns, as well as life cycle management activities for Drug Products.
• Lead experiments and laboratory activities to develop and/or optimize Drug Product formulation buffer.
• Support process investigations and assist with product impact assessment for change controls and internal/external investigation.
• Document study results in notebooks, forms, and technical reports.
• Communicate and present scientific findings in Process Development groups.

EDUCATION AND EXPERIENCE:

• BSc, MSc or PhD in Chemical Engineering, Biotechnology or another relevant engineering / scientific qualification. Level will be determined based on education and experience.
• Minimum Two (2)+ years of hands-on laboratory experience in Drug product development
• Strong computer skills with Microsoft Office and the ability to quickly learn new applications.
• Experience with formulation development, freeze/thaw, shipping and handling stability studies is desired.
• Technical understanding of Fill Finish operations for biologics products, including technical transfer to CMOs, unit operations, GMP requirements, media simulations, container/closure integrity, and regulatory requirements is desired.
• Experience in experimental design (DoE), summarizing and presenting data, and authoring technical reports.

DESIRED KEY COMPETENCIES:

• Critical thinking and strong quantitative and analytical skills.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Experience with SAS/JMP statistical software is desired.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits and open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.
• Working conditions and physical requirements:
• Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies.
• May need to work with hazardous materials.
• Able to stand up to 4 hours at a time.

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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