Regeneron is currently looking for an Associate QC Micro Specialist. 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. Drives continuous improvements for microbiological methods.

As an Associate QC Micro Specialist , a typical day might include the following:

• Perform Test Method validations, studies, and assisting on troubleshooting efforts (Investigations).
• Assist on taks related to building processes where gaps have been identified
• Participates on tasks associated to aseptic process simulations
• Take on activities associated with Change Control under the guidance of senior team members. This includes initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs
• Support the writing of technical documents and studies to troubleshoot and support investigations.
• Assist with the creation and update of SOPs
• Assist when data needs to be gathered for further analysis in support of investigations and business decision making.
• Seek streamlining opportunities in microbiology data capture, entry and analysis and bring them to the attention of the team.
• Seeks and evaluates alternative solutions/work arounds while obtaining buy-in from the organization. Effective and out of the box problem solving. Assists in the translation of ambiguity into actions.
• Assist in internal audit discussions and aligns with the team to address microbial requests.
• Assist the team in technical discussions and problem solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.
• Be ready to effectively communicate technical solutions to others in the organization.
• Assist on gathering support to make good judgements and quick decisions regarding microbiological methods
• Participate in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies
• Assist in the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, design of queries and reports.
• Suggest the incorporation of new items to the reference libraries for microbiological methods
• Be ready to help others across all aspects of the team, may mange others through influence rather than direct authority
• Influences policy

This role might be for you if:

• Facilitator with organizational agility
• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy
• Basic 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
• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company
• Facilitator with organizational agility
• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy
• Basic 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
• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company
• Facilitator with organizational agility
• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy
• Basic 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
• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company

To be considered for the Associate QC Micro Specialist you must have a BS/BA in microbiology or closely related field. Working experience in microbiology lab or pharmaceutical or biotech industry is preferred.

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.

$55,700.00 - $87,100.00