Senior Manufacturing Associate

This is a night shift position requiring a strong commitment to aseptic techniques, adherence to cGMP standards, and the ability to excel in controlled manufacturing environments.

Key Responsibilities

• Perform advanced manufacturing tasks, including:
• Weighing and preparing materials.
• Operating filtration systems and overseeing fermentation processes.
• Conducting cell inoculation and harvest operations.
• Utilizing chromatography systems and tangential flow filtration (TFF) equipment.
• Execute in-process testing such as pH, conductivity, spectrophotometry, osmolality, and cell counts.
• Prepare media and buffer solutions as required by production schedules.
• Ensure precise documentation of all activities in batch records and logs.
• Maintain and sanitize cleanroom environments; dispose of materials per protocols.
• Identify and promptly report deviations or unexpected issues to supervisors.
• Support process development teams with technology transfer initiatives.
• Uphold safety and operational procedures at all times.

Qualifications

• Education:
  An associate degree or higher in Biology, Chemistry, Biotechnology, or a related field is preferred. Equivalent industry experience (approximately 3 years in biologics manufacturing) will also be considered.
• Skills & Knowledge:
• Strong familiarity with GMP protocols and biotechnology operations, including aseptic filtration, fermentation, chromatography, and TFF processes.
• Ability to troubleshoot basic equipment and process issues effectively.
• Excellent attention to detail and the ability to follow detailed instructions.
• Competence in working independently and collaboratively within a team.
• Proficiency with software tools for word processing and data management.

Additional Requirements

• Flexibility to work night shifts in a fast-paced manufacturing environment.
• Commitment to meeting deadlines while maintaining high-quality standards.