Manager, Quality Control- Microbiology

1 month ago

Germantown, United States Precigen, Inc. Full time

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 hard-working Manager, Quality Control- Microbiology who is serious about their discipline and wants to be a key player in a high-performing team. This position will help lead the Quality Control team while also creating standard ways of working, hands-on training on microbiology techniques for lot release and clean room facility evaluation. The Microbiology Manager will oversee laboratory activities including testing and Environmental Monitoring of the facility. Responsibilities also include microbiology assay qualification, facility and utilities qualification, testing, investigations, and trending that are applicable to regulatory and corporate requirements.

DUTIES AND RESPONSIBILITIES:

* Oversees the implementation and execution of testing including microbial Assays, environmental monitoring (EM) and growth promotion testing.
* Complete routine record review of test data and related documents for in-process testing, utilities monitoring and drug substance release.
* Accountable for the management of the Environmental Monitoring (EM) program including monitoring and trending data.
* Responsible for the QC Microbiology and Aseptic Techniques training programs
* Ensures adherence to department, and site SOPs and other regulatory requirements.
* Lead investigations regarding out of specifications (OOS) results and EM excursion. Address and manage deviations related to microbiology/EM procedures. Evaluates and determines corrective actions.
* Assist in the preparation of dossiers and data packages for interaction between Precigen and regulatory agencies.
* Develop, revise, and review SOPs, qualification/validation protocols and reports.
* Responsible for QC's training and monitoring the GMP systems currently in place to ensure compliance with documented policies.
* Manage and conduct lab investigations, write deviations and own change controls.
* Perform duties as needed.

EDUCATION AND EXPERIENCE:

* 8+ years of experience with BS degree in Microbiology or related scientific discipline.
* 6+ years of experience with MS degree in Microbiology or related scientific discipline.
* Well versed in experienced in Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation (APV), USP/EP Microbiological methods and microbial identification and experience in managing a quality Control laboratory under GMP compliance.
* Strong experience in aseptic techniques, sterile gowning procedures and clean room operations.
* Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change controls.

DESIRED KEY COMPETENCIES:

* Ability to effectively negotiate and build collaboration amongst individuals.
* Demonstrate the ability to develop, coach and mentor key employees.
* 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.

#LI-ONSITE #LI-AZ1

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