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.
This is a 12-month temporary contract.
As a QC Micro Specialist, a typical day might include, but is not limited to, the following:
1. Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures.
2. Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations).
3. Applying a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations.
4. Assisting in the building of processes where gaps have been identified.
5. Leading tasks associated with aseptic process simulations.
6. Collaborating with team members on activities associated with Change Control.
7. Participating in the writing of technical documents and studies to troubleshoot and support investigations.
8. Applying expertise in the creating and updating of SOPs.
9. Leading data gathering and analysis in support of investigations and business decision-making.
10. Leading the evaluation of data entry, analysis, and reporting of microbiological data.
11. Participating in internal audit discussions and seeking alignment with the team to address microbial requests.
12. Collaborating in technical discussions and problem-solving with outside entities (i.e., contract manufacturers and contract test labs).
13. Assisting in effectively communicating technical solutions to others in the organization.
14. Assisting in the integration of technical updates into team procedures while maintaining compliance with regulatory agencies.
15. Staying current with industry trends in QC technology.
16. Implementing the creation and review of LIMS configurations to meet the needs of QC-Microbiology.
17. Assisting in the collection and maintenance of reference libraries for microbiological methods.
18. Assisting others across all aspects of the team.
This role might be for you if:
1. You are a facilitator with organizational agility.
2. You have advance knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility).
3. You have excellent written, verbal and interpersonal communication skills.
4. You have the ability to effectively interact with all levels both within and outside the company.
5. You can resolve and negotiate conflicts or problems with tact, diplomacy and composure.
6. You have the ability to handle multiple priorities with exceptional organizational and time management skills.
7. 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 2 years of relevant experience or equivalent combination of education and experience.
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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
Please note that certain background checks will form part of the recruitment process.
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