Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained. Drives continuous improvements for microbiological methods.
As a Senior QC Micro Specialist, a typical day might include, but is not limited to, the following:
- Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures, becoming the SMEs of these technologies, assays, and procedures
- Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity over time
- Applying a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations
- Assisting in the building of processes where gaps have been identified
- Leading tasks associated with aseptic process simulations
- Collaborating with team members on activities associated with Change Control. This includes initiating, impacting, and implementing the change; also initiating and closing workflows and CAPAs
- Participating in the writing of technical documents and studies to troubleshoot and support investigations
- Applying their expertise in the creating and updating of SOPs
- Leading data gathering and analysis in support of investigations and business decision-making
- Leading the evaluation of data entry, analysis, and reporting of microbiological data and supporting the implementation of changes to identify streamlining opportunities
- Suggesting alternative solutions/workarounds while obtaining buy-in from the organization
- Participating in internal audit discussions and seeking alignment with the team to address microbial requests
- Collaborating in technical discussions and problem-solving with outside entities (i.e., contract manufacturers and contract test labs) to drive resolutions
- Assisting in effectively communicating technical solutions to others in the organization
- Seeking support to make good judgments and quick decisions regarding microbiological methods
- Assisting in the integration of technical updates into team procedures while maintaining compliance with regulatory agencies
- Staying current with industry trends in QC technology
- Implementing the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementing new specifications, designing LIMS/ELN templates for new/revised test methods, designing queries, and reporting
- Assisting in the collection and maintenance of reference libraries for microbiological methods
- Assisting others across all aspects of the team, may manage others through influence rather than direct authority
This role might be for you if :
- You are a facilitator with organizational agility
- You can assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy
- You have advance knowledge 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
- You have excellent written, verbal and interpersonal communication skills
- You have the ability to effectively interact with all levels both within and outside the company
- You can resolve and negotiate conflicts or problems with tact, diplomacy and composure
- You have the ability to handle multiple priorities with exceptional organizational and time management skills
- You are proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance)
To be considered for this opportunity you should have a BS/BA microbiology with at least 5 years of relevant experience or equivalent combination of education and experience.
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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