Regeneron is currently looking for a Manager for our QC (Quality Control) Microbiology Tech Studies team. This position will specialize in QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained. They will drives continuous improvements for microbiological methods.
As a Manager QC Microbiology ,
a typical day might include the following:
- Ensure department metrics and cycle times are monitored and achieved.
- Provide management and direction to microbiology laboratory staff.
- Oversee daily operations and address lab needs.
- Monitor environmental monitoring and testing schedule, progress, data and work quality.
- Conduct trouble-shooting and OOS investigations.
- Direct the efforts and study design for qualifying new utility systems and classified areas.
- Assist manufacturing and facility departments to solve microbiology related deviation issues.
- Maintain product timeliness.
- Assist in creation, implementation and administration of microbiology based programs.
- Represent QC during regulatory inspections to respond and address microbiology issues and solutions.
- Guides/Participate in tasks associated to aseptic process simulations.
- Guides the team members on activities associated with Change Control. This includes initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs
- Guides, Authors and Reviews technical documents and studies to troubleshoot and support investigations.
- Mentors the Implementation of opportunities identified to streamline data entry, analysis, and reporting of microbiological data and support implementation of changes.
- Independently finds alternative solutions/work arounds while obtaining buy-in from the organization. Effective and out of the box problem solving. Translates ambiguity into actional steps.
- Mentors and Participates in internal audit discussions and coaches team to address microbial requests.
- Leads and Participates in technical discussions and problem solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.
- Guides and Integrates technical updates into the team procedures while maintaining compliance with regulatory agencies
This role might be for you if you:
- Understand test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.
- Are able to make good judgements and quick decisions regarding microbiological methods
- Facilitate with organizational agility
- Develop, guide and support strategies on how to achieve what needs to be done and develops metrics to measure the strategy
- Are an expert in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
- Can resolve and negotiate conflicts or problems with tact, diplomacy and composure.
- Ability to handle multiple priorities with exceptional organizational and time management skills.
- Are proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance)
To be considered for the Manager QC Microbiology you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences, or a related field, Biology, Microbiology preferred and 7+ years of relevant experience and some leadership experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)
$101,800.00 - $166,000.00