Microbiologist I - Environmental Monitoring and Testing

Company Overview:

SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials, and analytical services for the pharmaceutical industry worldwide.

Position Summary:

As a Microbiologist I within the Microbiology Department, your activities will support various projects related to cell and gene therapy products. This role presents unique opportunity to grow diverse technical and intellectual skills in a highly dynamic and impactful environment. We are looking for an individual who is highly motivated by our mission and technology, is self-organized, and is flexible to support a range of projects within a fast-growing organization, must be independent, goal oriented, and able to efficiently work across multiple projects.

Primary Responsibilities:

• Collaborate with a diverse team to develop projects related to cell and gene therapy products
• Aseptically gown into classified areas to perform Environmental Monitoring for Viable and Non-Viable Air, Surface plates, Settle plates, and Swab sampling in testing labs and cleanroom facilities as assigned. Perform personnel sampling for gowning qualifications and aseptic manipulation qualifications as assigned
• Perform microbial testing of raw materials, bulk, finished products and aseptic packaging components. Testing may include the following: water sampling, plate enumeration, growth promotion of microbiology media for acceptance testing and release, and subculturing for microbial identifications, etc. Report all excursions in a timely manner to management and impacted departments
• Maintain accurate laboratory records and generate, analyze, and record high quality data. Perform data analysis, trending of data, and draft technical reports to comply with good laboratory practices and standard operation procedures
• Maintain logbooks related to inventory and equipment, maintain equipment as required
• Maintain positive relationships and network effectively across departments, collaborate across departments for scheduling, performance of testing and projects, and completion of required tasks
• Document laboratory deviations, incidents, and investigations as assigned
• Ensure compliance with GMP regulations for of all activities performed
• Ensure appropriate facility support and provide technical expertise
• Create and revise all GMP document types within Veeva i.e., SOPs, forms, work instructions, etc., as assigned
• Perform other assignments and assist with other tasks/projects as assigned
  
  

Education, Experience, & Qualification:

• Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
• A proven ability to collaborate with team members to complete projects in an efficient and timely manner
• Capability and desire to work in a dynamic, fast-paced, innovative environment
• Prior experience with working in a GMP lab is highly desirable
• Understanding of compliance and cGMP considerations
  
  

Key Competencies:

• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software
  
  

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• Prolonged periods of standing in Cleanroom Facilities
  
  

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

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