Summary: The Senior Manufacturing Technician will work directly with culture and viral propagation techniques, cell culture and bioreactor operations and aseptic techniques while following cGMP procedures.
• Prepare medium, monitor cultures, take samples, turn-around of fermenters, sterilization and inoculation.
• Participate in writing standard operating procedures (SOPs) and batch production records.
• Assist senior staff in implementing project safety and quality assurance programs.
• Provide input and support to R&D functions during development and scale up activities
• Maintains the confidentiality of proprietary company information.
• Maintains an effective working relationship with others.
• Ensure proper documentation and execution of Batch Production Records
• Perform all other duties as assigned.
Required Skills & Abilities:
• Excellent communication and interpersonal skills.
• Demonstrated leadership skills.
• Excellent organization skills.
• Strong proficiency with Microsoft Office applications.
• Good attention to detail.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Undergraduate degree in Biology, Microbiology, Chemistry, Engineering or related field.
• Previous supervisory experience.
• Experience with cultivation at manufacturing scale of 1000L or greater or pilot scale cell culture vessels.
• Experience with Mammalian Cell, Insect Cell, Yeast and Bacterial Cell Lines.
• Experience with MAb, pDNA, and Viral Propagation technologies.