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Biomanufacturing Specialist

Biomanufacturing Specialist Job Description

Review this Biomanufacturing Specialist job description for a reference when building your resume. Review the qualifications and requirements listed to get an understanding of what you need to include on your resume for what employers would look for in this field.

SUMMARY:

A Biomanufacturing Specialist is a specialized professional responsible for the efficient and compliant production of biopharmaceuticals, vaccines, and biologics. This role focuses on executing bioprocesses, maintaining equipment, and ensuring the quality and safety of biomanufactured products.

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FUNCTIONAL DUTIES:

  1. Bioprocess Execution:
    • Operate and monitor bioprocessing equipment for the production of biopharmaceuticals.
    • Perform upstream and downstream processing steps, including cell culture, fermentation, and purification.
  2. Quality Control and Assurance:
    • Implement quality control measures to ensure biomanufactured products meet industry standards and specifications.
    • Perform in-process and final product testing to verify product quality and purity.
  3. Equipment Maintenance and Troubleshooting:
    • Maintain and troubleshoot bioprocessing equipment, ensuring it functions optimally.
    • Identify and address equipment issues to minimize production disruptions.
  4. Process Documentation:
    • Maintain detailed records and documentation of bioprocessing activities.
    • Generate batch records and standard operating procedures (SOPs) for manufacturing processes.
  5. Regulatory Compliance:
    • Ensure biomanufacturing processes comply with industry regulations, such as cGMP and FDA guidelines.
    • Assist in the preparation of regulatory submissions and responses to regulatory inquiries.
  6. Batch Record Review:
    • Review and approve batch records, ensuring accuracy, compliance, and adherence to standard procedures.
    • Investigate and resolve discrepancies or deviations as necessary.
  7. Cross-Functional Collaboration:
    • Collaborate with cross-functional teams, including quality control, quality assurance, and regulatory affairs, to achieve project objectives.
    • Communicate findings, project progress, and recommendations to team members and management.
  8. Technology Transfer:
    • Support the transfer of processes and technology from development to manufacturing teams.
    • Ensure the smooth integration of new processes into production.

REQUIREMENTS:

  • Bachelor’s or Master’s degree in bioprocessing, biotechnology, or a related field.
  • Proven experience in biomanufacturing, bioprocess execution, and quality control.
  • Proficiency in operating bioprocessing equipment and associated software.
  • Strong analytical and problem-solving skills.
  • Excellent communication and teamwork skills to collaborate with cross-functional teams and project stakeholders.
  • Attention to detail and a commitment to precision and quality.
  • Knowledge of biomanufacturing principles, industry standards, and regulatory compliance.
  • Project management skills for process execution and documentation.
  • Ability to manage multiple projects and meet deadlines.
  • Continuous learning and a willingness to adapt to new technologies and industry developments.

Note: This job description is intended to provide a general overview of the position and is not exhaustive. Duties and responsibilities may be adjusted to meet the specific needs of the biomanufacturing organization or biopharmaceutical company.

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