Senior Manager, QC Microbiology - United States
Want to know company name or location? Company managed [?]
Posted on : 06 June 2017
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking QC Microbiology, Senior Manager to manage company QC Microbiology Department.
Responsibilities (include but are not limited to):
- Manage company EM and Micro departments at company sites. Establish, validate and sustain environmental monitoring program for company sites
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Establish user requirements for purchase, qualification of company’s QC microbiological and equipment.
- Work with internal and external resources to maintain equipment in an optimal state
- Create working schedule for EM and QC microbiology lab in advance
- Revise and modify EM and PM SOPs per USA and EU guidelines
- Assemble data and write reports on findings from environmental monitoring of company’s cGMP facility
- Monitor and trend data for EM and PM readings. Update management on environmental trends. Implement corrective action plans when necessary
- Assist in the preparation of dossiers and data packages for interactions between company and Regulatory agencies and interact with agents from Regulatory agencies and participate in Pre-Approval and post approval inspections
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Monitor the training records for the lab personnel. Make sure that % training completion rate is >90%
- Gather metric information for use in continuous improvement of areas of responsibility
- Conduct audit of internal testing labs and outside testing labs
- Give weekly updates to your manager on time
- Prepare monthly performance metrics by first week of every month.
- Interact with the QC Laboratory personnel to plan and schedule testing at scheduled time points
- Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
- Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
- Perform other duties as assigned as on need basis
- Ph.D. Micro biologist preferred with 8-10 years or MS with 10 – 12 years as Microbiologist in a pharmaceutical or in other FDA regulated environment
- Demonstrated successful management of Environmental monitoring, Personnel monitoring in manufacturing suites and successful management of QC Microbiology labs
- Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin and Gram Stain), ELISA and other routine chemical tests and strong experience in managing testing by compendial methods
- Deep understanding of experimentation and data analysis and data trending using different statistical software packages
- General understanding of pharmaceutical GMPs and 21CFR Part 11, EU and Japanese pharmaceutical regulations
- Experience in data management, change control, GMP and compliance.
- Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
- Ability to communicate complex scientific findings and recommendations in one-on-one discussions and in departmental meetings.
- Excellent technical writing experience such as SOPs, protocols, and reports, and writing analytical sections on microbilogical methods for Regulatory Filings
- Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.
- Strong computer, scientific, and organizational skills.
- Ability to work independently and as part of a team with internal and external teams with excellent communication skills
- Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal and written communication skills.
- Experience with a LIMS system preferable
- Ability to prioritize, manage multiple tasks, and meet deadlines.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.