The Supervisor Microbiology reports to the Director of Quality Control. They provide leadership to the microbiology laboratory through all phases of development. They are responsible for managing the microbiological evaluation of raw materials, components, drug product intermediate, finished drug product and stability samples. They are also responsible for managing the environmental monitoring and aseptic process simulation programs. They are required to work in development and regulated environments, including adherence to cGMPs, regional and country specific regulations, as well as internal SOPs.
ESSENTIAL DUTIES & RESPONSIBILITIES- Oversee microbiological testing activities for several of the following functions but not limited to raw material, component, drug product, stability, validation, investigational, in-process testing, etc.
- Oversee environmental monitoring, aseptic process simulation and gowning qualification programs.
- Serve as a subject matter expert for microbiology.
- Lead, guide, and mentor analysts
- Foster a culture of continuous improvement.
- Ensure the laboratories are clean, organized, compliant, and audit ready always.
- Support formulation, process development, and scale-up activities
- Review and approve laboratory data for accuracy and completeness.
- Lead and serve on cross-functional project teams.
- Prepare protocols, technical reports, and other documentation for CMC related activities.
- Identify and resolve project-related issues that have the potential to impact project deliverables.
- Ensure compliance of laboratory personnel and equipment
- Prepare annual laboratory budgeting.
- Perform annual performance assessments of direct reports.
QUALIFICATIONS- Bachelor's degree in biology, or related science and 8-10 years of experience in a pharmaceutical laboratory management role.
KNOWLEDGE, SKILLS, & ABILITIES- Must possess strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, microbiological testing techniques, and cGMP.
- Strong track record of leadership skills and influence
- Strong interpersonal skills. Ability to build effective and constructive relationships.
- Ability to work cross-functionally both internally and externally
- Must be a leader, mentor, and self-motivated to develop a high performing team
- Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, and organizational skills
- Demonstrated analytical and problem-solving skills
PHYSICAL REQUIREMENTSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
