Job Scope:The Sr. Manager-Microbiology Laboratory provides direction and/or conducts an area’s daily workload planning, compliance, and overall customer service. The candidate must be committed to personnel interactions and will spend considerable time as a mentor/coach of reporting staff. Is also responsible for coordinating and overseeing duties in the Microbiology Lab following written methods, policies, procedures, and guidelines to ensure compliance with the established corporate and regulatory standards. Will also coordinate laboratory testing and supply of materials.Key Objectives/Deliverables•Manage day-to-day business by interacting with production planners, sample submitters, et.al, to manage laboratory workload and throughput.•Manage controlled substances, as applicable.•Maintain a high-level understanding of the laboratory processes and be responsible for analyst training on laboratory methods and proper sample handling.•Enforce compliance with all procedures, methods, and other regulatory commitments.•Provide technical understanding of the regulations applicable to laboratory testing for cGMP purposes.•Participate as primary laboratory subject matter expert for internal and external audits.•Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.•Oversee team’s performance, including providing opportunities for growth as part of the development of their career plans.Basic Experience Requirements•MS Microbiology or related science; PhD preferred.•5+ years’ experience in QC Microbiology Laboratories•Demonstrated understanding of cGMP regulations, compliance requirements and regulatory expectations•Knowledge and experience with laboratory testing techniques practices in support of testing for endotoxin, bioburden, sterility, utilities support, as well as an understanding of aseptic techniques, and environmental monitoringAdditional preferences:•Fully bilingual (English/Spanish)•Strong interpersonal skills and teamwork oriented•Strong verbal and written communication skills•Ability to focus on continuous improvement.•Strong compliance mindset and sound judgement•Effective time management•Effective problem-solving skills•Previous experience leading and managing a team.•Strong attention to detail•Proficient in computer system applications•Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.Additional Information:•The position supports a 24/7 operation, and the candidate must be able to support off-shift requests.•Minimum travel required.