A global biotech organization is looking to add to their Quality Control team with a QC Technical Services Manager. With many exciting projects in their pipeline, you will always have something to look forward too!
- Oversee a team of Scientists who are responsible for technical transfer of QC analytical methods into facility.
- Ensure QC policies and procedures appropriate, as necessary.
- Ensure Regulatory and customer inspection readiness and participate in audits as required.
- Organize, hire, train staff. Identifying and structuring work that needs to be performed towards that area of responsibility.
- Manage long and short-term projects regarding investigations, analytical transfer, PQR's, and others…
- Develop and identify plans for efficient technical transfer.
- Review and author validation reports and protocols while understanding data for analytical validations.
- Act as Liaison at external and internal Customer and Team meetings.
- Bachelor's in biology, Biochemistry, or related or MS/PhD (a plus).
- 3-5 years in a supervisory position
- 5-10 years of strong QC Lab experience
- 5 years of CDMO transfer skills
- 5+ years of validation and transfer experience
- Experience using Microsoft project, and able to plan projects almost a year in advance.
Analytical method validation and instrument validation experience