Job Title:
Chemistry Quality Control Laboratory Leader
Job Summary:
We are seeking a Chemistry Quality Control Laboratory Leader to lead our QC Analytical team and ensure the continued success of the team.
Key Responsibilities:
The ideal candidate will have a BS in science or equivalent, 2-5 years of laboratory experience, and 2-5 years of supervisory experience. They must be able to interpret impact of laboratory data for appropriate and effective actions, identify problem areas requiring development, maintenance, production, engineering, accounting, or planning, and communicate and follow-through to completion and assist in the development of necessary corrective action plans to resolve the problem with supervision.
Requirements:
* BS in science or equivalent (Chemistry, Microbiology, or Biology preferred)
* 2-5 years of laboratory experience
* 2-5 years of supervisory experience
* Demonstrated skills to deal effectively with members of the department and the areas serviced by the laboratory
* Problem solving skills required
Preferred Qualifications:
* A strong background in HPLC, Raman, and Analytical methods, along with experience with SampleManager and Empower systems, is highly desirable.
* Involvement in product transfers/method transfer, method development experience, good knowledge of Data Integrity from Laboratory perspective, and knowledge of ADC (Antibody-Drug Conjugate), mAb (Monoclonal Antibodies) and Aseptic process production are also advantageous.
Business Skills:
* Excellent communication, organization, time-management and teamwork skills
* Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures
* Requires total commitment to quality and maintaining a high standard of work at all times
* Demonstrate ability to work on one's own initiative
* Strong Problem-solving skills
About This Role:
This role will involve leading the QC Analytical laboratory operations and ensuring compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others.