Medgene Labs helps veterinarians and producers protect livestock with precisely constructed immunological products and services. Applying a strategy of continual diagnostic surveillance and data analytics to the practice of immunology, creating vaccines for the disease-at-hand quicker and more precisely than previously possible. Medgene Labs has a single mission: To be a world-class Immunological Services Provider for leading livestock producers and their veterinarians. Medgene is seeking to hire a Process Development and Improvement Associate Scientist for our rapidly growing business and product pipeline.

Purpose:

Perform process development and improvement studies as directed by the Process Development and Improvement Leader.

Distinguishing Feature:

The Process Development and Improvement Associate Scientist is responsible for executing process development and improvement studies for the manufacture of recombinant proteins. The position requires the ability to write, 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.
• Execute experiments in small scale bioreactors and fermenters to optimize expression and product quality of recombinant biologics.
• Maintain detailed and accurate laboratory notebooks/batch records.
• Have proven hands on experience in aseptic techniques.
• Perform production of buffers, growth media, and solutions.
• Help maintain laboratory equipment, supplies, and a clean/safe working environment.
• Assist with production activities as needed.
• Work with Production on transfer of products.
• 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.
• Performs other work as assigned.

Reporting Relationships:

Reports directly to the Process Development and Improvement Leader. Indirectly reports to the VP of Manufacturing.

Challenges and Problems:

Challenged to provide effective, safe vaccines to commercial clients in a timely manner. Assist with investigations into poorly-growing cultures, inefficient yields, processing problems. Keeping of detailed records will be an absolute necessity, subject to Audit by the Regulatory and Compliance Officer and Quality Assurance.

Decision-Making Authority

The Process Development and Improvement Leader is responsible for making experimental decisions involved in the efforts of the position in order to deliver accurate, concise, and timely data. Decisions may also be delegated to Process Development and Improvement Leader by the Vice President of Manufacturing.

Contact with Others:

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

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:

• BS in Biochemistry, Biology, or equivalent.
• Previous experience with fermentation and/or cell culture, chromatography, or other downstream processing techniques.
• Basic level knowledge and understanding of 9CFR.
• Basic level knowledge and understanding of hazardous material handling.
• Aseptic Techniques and good laboratory practices.
• Good Documentation Practices.

Ability to:

• 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.