R&D Manager

  • location: Libertyville, IL
  • type: Permanent
  • salary: $90,000 - $110,000 per year

job description

Position: Manufacturing Supervisor

$90K - $120K

4 Openings - Night Shift - 6pm - 6am

Week 1: Work Monday, Tuesday. Off Wednesday, Thursday.

Work Friday, Saturday Sunday.

Week 2: Off Monday, Tuesday. Work Wednesday, Thursday.

Off Friday, Saturday, Sunday.

Reports to: Manufacturing Manager

Position Summary

Areas of responsibility could include both upstream (cell culture), downstream (Purification), and fill/finish activities. Shift structure could include 12 hour rotating positions.

6 am - 6 pm. Rotating 3-2-2-3. Every other weekend off.

Primary responsibilities include:

- 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.

Required Education and Experience

- 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:

o Solid knowledge of FDA regulations and GMP systems

o Excellent oral and written communication skills. Strong technical writing ability required.

o Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. Demonstrated leadership skills.

o Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.

o Experience with viral manufacturing and transfection a plus.

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