Manufacturing Associate

Medgene Labs seeks a full-time Manufacturing Associate at Level IV depending on experience. The successful candidate will report to the BioProcess Sciences Manager. The individual will be responsible for providing daily operational needs in support of the Manufacturing staff. The ideal candidate will show capacity to perform detail-oriented work and successfully integrate with a strong Manufacturing team.

Purpose:

Perform daily laboratory operations of Vaccine Production within the site's described procedures.

Distinguishing Feature:

The Manufacturing Associate is responsible for manufacturing of vaccines, in accordance with established methods. Knowledge of basic laboratory procedures and aseptic techniques are preferred. The position requires the ability to read and understand standard operating procedures and be able to execute the procedures to ensure compliance with CVB regulations. Good documentation practices are required while documenting the work that is being performed.

Functions:

• Read and understand SOPs and Protocols for manufacturing vaccines.
  • Maintains records detailing adherence to established policies.
• Manufacturing of veterinary vaccines in compliance with CVB guidelines and regulations.
  • Maintains appropriate records commensurate with CVB guidelines.
  • Ensures high-quality production standards from culture through bottling.
• Ensure security of Master Seed, Unreleased, and Released Products.
• Assist with creating the conditions for increasing productivity by analyzing and improving existing processes as well as improving technology transfers and minimizing losses.
  • Maintenance of all laboratory equipment, facility, and standards within the Vaccine Production division.
• Assisting with the planning and organizing of production processes as well as providing guidance and training to staff through instructions and SOPs.
• Ensure compliance with aseptic procedures and cleaning schedules.
• Performs other work as assigned.

Reporting Relationships:

Reports directly to the BioProcess Sciences Manager. May take direction from Manufacturing Senior Scientists.

Challenges and Problems:

Challenged to provide effective, safe vaccines to commercial clients in a timely manner. Assist with different problems such as mechanical/equipment failure, contamination, poorly-growing cultures, incomplete inactivation and failure of serial release. Keeping of detailed records will be an absolute necessity, subject to Audit by the Regulatory and Compliance Officer and Quality Assurance.

Decision-Making Authority

Decisions may be delegated to Manufacturing Associate Scientist by BioProcess Sciences Manager or Senior Scientist.

Contact with Others:

Daily contact with manufacturing, QA, and QC personnel. Limited contact with Regulatory, Sales and Marketing, and R&D personnel.

Working Conditions:

Potential for exposure to human and animal pathogens, including blood-borne pathogens. Exposure to infectious agents, dangerous chemicals, high-voltage equipment, toxic fumes, high-pressure steam, temperature extremes, and potential mutagens.

Knowledge, Skills, and Abilities:

Knowledge of:

• Aseptic Techniques and good laboratory practices.
• Good Documentation Practices.
• Microbiology background is preferred.

Ability to:

• Perform various cell culture and bacterial growth methods.
• Follow specific procedures.
• Work safely with infectious materials and specimens.
• Operate scientific equipment and computers.
• Establish and maintain effective working relationships with others.
• Keep detailed and accurate documentation.
• Maintain a safe work environment for self and other employees at all times.