Job Description

The Development team is looking for a motivated team member to join the fast-paced group and contribute to the process and analytical activities to take our TCR products into clinical production. We are looking for someone interested and eager to learn cutting-edge technologies and assist in the tech transfer and production of the products.

Responsibilities

• The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the level of training and experience of the employee
• Work is primarily in Grade B and Grade C aseptic manufacturing environments but may also include support of process development runs in the Manufacturing Science and Technology laboratory
• Performs cell manufacturing-related activities while wearing clean room attire in an aseptic cGMP manner
• SME on unit operations
• Documents production operations in corresponding batch records and log books per established procedures, ensuring accuracy and timely completion
• Identifies real-time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner
• Inputting and uploading of manufacturing data in real-time to the existing database
• Works with the Quality team to author out-of-specification (OOS) reports, deviation investigations and corrective and preventative actions
• Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned
• Handles human blood and human blood-based product intermediates; Helps with warehouse management, critical reagents and material inventory reports
• Review of Batch Records and logbooks / comment resolution
• Work on project teams (continuous improvement initiatives)-
• Organize and support process development studies in the PD laboratory
• Train new or junior employees on equipment and unit operations
• This is a start-up situation, so schedules and shifts will change over time
• Other duties as assigned
• Title may vary with experience

Qualifications

• Bachelor’s or Master’s degree in a cell biology, bioengineering, or medical technology-related field, or equivalent experience is required
• Ability to work flexible hours with some night and weekend availability is required
• Ability to stand for multiple hours and lift 20 pounds
• Excellent verbal and written communication skills are required
• Computer literacy is required, including Microsoft Outlook, Word, Excel, and PowerPoint
• 0-5 years’ experience working within cGMP regulated environment, including Good Documentation Practices (GDP)
• 0-5 years’ of research laboratory experience
• Experience with Mammalian Cell Culture

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