Shift: Wednesday-Saturday, 12:00pm-10:30pm
Specific Responsibilities (including but are not limited to):
- Lead a team of high-performing individuals, with particular focus on individual development in support of greater team achievement.
- Drive a culture of Operational Excellence in the group.
- Supervise Analytical QC testing and various other support activities performed in the Analytical QC Lab.
- Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Responsible for overseeing on-time completion of training for the group.
- Monitor GMP systems currently in place to ensure compliance with documented policies.
- Expectation includes a hands-on, collaborative approach to problem solving, planning, and people-management.
- Participate in and support development and implementation of Operational Excellence initiatives to enhance laboratory and staff efficiencies.
- Participate and/or lead daily and weekly team meetings.
- Work with internal and external resources to maintain analytical equipment in an optimal state.
- Oversee purchase and qualification of equipment, materials and media required for routine testing and reagent qualification.
- Responsible for OOS, lab and protocol deviations, and corrective action plan implementation when necessary.
- Provides input and support in the development, revision and review of SOPs, protocols and reports.
- Participate in inspections by both internal and external stakeholders as needed.
Basic Qualifications:
- MA / MS Degree with 3+ years of analytical and/or cGMP operations and/or quality experience OR
- BA/BS Degree with 5+ years of analytical and/or cGMP operations and/or quality experience OR
- High School Degree with 9+ years of analytical and/or cGMP operations and/or quality experience
Preferred Qualifications:
- Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry.
- Demonstrated guidance and overseeing skills, including establishing direction and goals, and guiding implementation while fostering a team-based environment.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Experience in any of the following analytical techniques, Flow Cytometry, PCR, ELISA, cell viability measurement.
- Familiarity with FDA, EU and ICH guidelines.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP.
- Comfortable in a fast-pace company environment with minimal direction and able to adjust workload based on changing priorities.
- Ability to think critically and demonstrate troubleshooting/problem solving skills.
- Excellent skills in Microsoft Office, data analysis software, and other related applications.
