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
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.