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Manager, Lab Operations

2 months ago

Germantown, United States Precigen, Inc Full time
Job DescriptionJob Description

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 hard-working Manager, Quality Control – Lab Operations who is serious about their discipline and wants to be a key player in a high-performing team. This position will lead Sample Management, Stability Program, Sample Shipping and Outside Testing Services. Initially, this position will be an individual contributor establishing processes for the sample management function including stability management and interface with the manufacturing and testing groups. The position will then transition to be primarily responsible for providing leadership to the Sample Management function. Additionally, you will be a critical part of the leadership of the QC function, helping to provide strategy for the entire group as part of a high performing leadership team at a demanding and fast-paced facility.

DUTIES AND RESPONSIBILITIES:

  • Identify and implement processes to support sample receipt and processing for release testing and stability in support of the testing groups
  • Manage the raw materials, In-process and Final Product Specifications
  • Manage the Stability Program
  • Manage the shipping of samples to external Testing Laboratories
  • Author, implement, and review changes to controlled documents
  • Complete routine record review of sample chain of custody information and related documents for samples.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Assist in the preparation of dossiers and data packages for interactions between company and Regulatory agencies. Interact with agents from Regulatory agencies during on site audits
  • Perform duties as needed.

EDUCATION AND EXPERIENCE:

  • BS / BA and 8+ years of Quality Control experience or MS / MA and 6+ years of Quality Control experience or PhD and 4+ years of Quality Control experience.
  • Demonstrated ability to lead a functional area
  • Candidate should be well versed and experienced in Micro and analytical methods and experience in managing a Quality Control laboratory under GMP compliance.
  • Strong Experience in applying GMP in QC lab in conformance to U.S.
  • Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control

DESIRED KEY COMPETENCIES:

  • Ability to effectively negotiate and build collaboration amongst individuals.
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.

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.