Associate/Manufacturing Specialist, MS&T
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Job Detail
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Job Description
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 a hard-working Associate/Manufacturing Specialist, MS&T 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 perform a broad range of tasks to support cGMP manufacturing activities. This includes performing  deviation investigations, root-cause analysis, CAPAs, change controls as needed in support of manufacturing, generating manufacturing documentation as needed, and liaising with other departments. Prior experience in GMP manufacturing and operation of GMP process equipment are preferred. This position will focus on the technical aspects of manufacturing support (MS&T) with some hands on support of the daily manufacturing activities, as assigned.
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DUTIES AND RESPONSIBILITIES:
- Perform manufacturing deviation investigations, assessing root cause and determining corrective and preventive actions; and document in the quality systems
- Generate documentation in support of manufacturing activities, including master batch records and standard operating procedures.
- May be needed to perform GMP manufacturing activities, including, but not limited to:
- Assembling raw materials
- Execute Batch Production Records (BPR) under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps, as assigned
- Support routine cleaning and changeover procedures for clean room suites and equipment
- Participating in and facilitating technology transfer
- Work in a team based, cross-functional environment to complete production tasks.
- Adhere to all safety and regulatory requirements while performing  job functions.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree or master degree in engineering, biology, biomedical science or life science.
- Minimum of 3 year in a GMP environment and/or in manufacturing support required.
- Experience in Performing deviation investigations and root-cause analysis required.
- Familiarity with change control and CAPAs preferred.
- Author of GMP documentation, including batch records and SOPs required.
- Prior Tangential Flow Filtration (TFF) experience is preferred.
- Prior cell culture experience in a GMP facility is preferred.
- Knowledge of principles and practices of current Good Manufacturing Practices (cGMPs.)
DESIRED KEY COMPETENCIES:
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.Sound technical writing skill and/or formal training
- Strong technical and scientific knowledge of upstream and downstream vaccine/vector purification unit operations
- Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
- Ability to problem solve
- Familiarity with quality management systems and root cause analysis tools
- Positive interpersonal skills.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Ability to manage multiple and varied tasks, and prioritize workload.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Proficient in MS-Word and MS-Excel.
- Strong quantitative and analytical skills.
- Understanding  of Operational Excellence (OE) methodologies and statistical data analysis, is a nice to have
- Ability to understand and execute on the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Responsive, can-do attitude.
- Deals with conflict in a direct, positive manner.
- Ability to think and adapt to a rapidly changing environment and demands.