Manufacturing Supervisor

US-IL-Libertyville
1 month ago
Job ID
2017-1030
# of Openings
1
Category
Manufacturing

Overview

Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

 

The Supervisor of Manufacturing is responsible for organizing, managing, and continuously improving the manufacturing operations and process at the AveXis manufacturing site. This individual will be directly responsible for a team of BioProcess Engineers whose direct responsibilities include producing product on the manufacturing floor and troubleshooting equipment. The manufacturing supervisor will be the first line of contact to handle process and equipment deviations on the floor. Areas of responsibility could include both upstream (cell culture), downstream (Purification), and fill/finish activities. Shift structure could include 12 hour rotating positions.

Responsibilities

  • Produce clinical and commercial material on an annual basis that meets the site’s strategic objects and is compliant with cGMPs and safety regulations.
  • Point person on shift to assign/distribute the work and coordinate emergency situations.
  • Lead investigations as related to the manufacturing process.
  • Author deviations, nonconformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
  • Ensure documentation (batch records and SOPs) are accurate and updated as required.
  • This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
  • Demonstrate an appropriate level of understanding of the operations performed in the production unit.
  • Identify and implement continuous improvement opportunities.
  • Summarize shift progress via email at the end of the shift.
  • Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions).
  • Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.

Qualifications

  • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience
  • A minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:
    • Solid knowledge of FDA regulations and GMP systems
    • Excellent oral and written communication skills. Strong technical writing ability required
    • Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. Demonstrated leadership skills
    • Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets
    • Experience with viral manufacturing and transfection a plus
  • Additional requirements: Must be able to lift over 35lbs

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

 

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