Manager, Microbiological Control

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. 

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. 

Position Summary

The Manager, Microbiological Control is responsible for supervising the laboratory staff performing microbiological testing of in-process, drug substance, utilities, stability, and raw material samples in functional areas including bioburden, endotoxin, microbial identification, growth promotion, viral testing, and general laboratory procedures.

Duties & Responsibilities

• Promote quality, safety, and health by ensuring adherence to procedures and safety culture.
• Supervise the daily operations and schedule of the laboratory staff, in performance of microbiological analyses to evaluate in-process, drug substance, utilities, stability, and raw material samples.
• Provide training, coaching, feedback, and facilitate development of direct reports.
• Provide technical expertise, leadership, and guidance to the Microbiology team on execution of laboratory procedures. and practices to assure testing occurs in a manner that is efficient and compliant with cGMPs, compendia requirements, and regulatory expectations.
• Review, analyze, and interpret laboratory data and documentation, notify clients of results, and assist to resolve issues, if applicable.
• Review and approve laboratory investigations and CAPA.
• Assist with troubleshooting and resolution of complex issues.
• Author and/or review and approve laboratory SOPs, test methods, risk assessments, protocols, technical reports, and other documentation related to microbiological testing, as required.
• Ensure laboratory inspection readiness and provide support for regulatory inspections and audits.
• Ensure timely completion of periodic review of procedures and microbial studies as required to assure adherence to current regulatory requirements.
• Identify/execute continuous improvement opportunities to reduce operational variances and improve laboratory efficiency using lean principles.
• Work across organizational boundaries to share best practices and support network initiatives to achieve alignment of company objectives.

Education & Experience

• Knowledge of science generally attained through studies resulting in a B.S. in physical or life sciences (e.g. microbiology, biochemistry, molecular biology, or related discipline)
• Minimum 5 years of experience in a cGMP Biopharmaceutical environment with previous microbiology laboratory experience.
• Demonstrated technical knowledge in microbiological quality control testing procedures, aseptic technique, equipment/instruments, and laboratory investigations.
• Experience interpreting and applying cGMP concepts, compendia, and regulatory requirements to daily laboratory operations and associated method studies and projects.

Knowledge, Skills, Abilities

• Demonstrated ability to lead, direct and influence others in a team based collaborative environment to meet objectives of department and company.
• Demonstrated knowledge of microbiological testing procedures with the application and interpretation of cGMP concepts and compendia requirements to daily laboratory operations.
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Work in fast paced environment and prioritize work to meet deadlines and objectives.
• Knowledge of good documentation practices, cGMP, regulatory requirements, and ability to train others in areas of expertise.
• Ability to analyze, evaluate, and interpret data.
• Troubleshoot issues associated with methods, equipment/instruments, and laboratory procedures.
• Knowledge of applicable business systems including electronic laboratory systems, Delta V, Maximo, SAP.
• Excellent written and verbal communication skills

Physical Demands

This is both an office and laboratory-based position that may require repetitive use of arms, hands and wrists, especially when working with computers. Depending on work demands, office-based work requires sitting.

Work Environment

This position is an office-based position that will require entry into the laboratory that requires appropriate levels of personal protective equipment (PPE) and awareness of presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents. This position is based indoors, and primarily be working with others, but also independently and alone at times.

Supervisory Responsibilities 

• Will supervise a direct staff of approximately 5 employees.
• Oversee work including lead, train and direct work of others to meet company and department objectives.
• Provides coaching, feedback, training and performance evaluations.
• Develop and grow staff technically and professionally by directing development efforts towards excellence and higher degree of proficiency

Travel

Some travel may be required for this position at times. 

Target Bonus

10%

 

Work Location

East Syracuse, NY 

We are an Equal Employment Opportunity (“EEO”) Employer. 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!