Manufacturing Support Specialist

Job Description

Summary: This position will report into Manufacturing to provide leadership and direction for clean room contamination control in support of all manufacturing programs; including, but not limited to the manufacturing process and associated clean utilities, qualification and validation activity, microbial sampling/testing practices, data trending, and investigations. Oversees the Manufacturing microbial control for commercial manufacturing production in addition to implementation of improvements.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Ensures that all manufacturing clean room controls are in compliance with cGMP guidelines and applicable regulations.

• Reviews and provides feedback on area procedures, including SOP’s, master batch documentation, change controls, and validation protocols/reports in accordance with cGMP standards.

• Chairs reoccurring and ad-hoc cross functional teams in support of manufacturing microbial control initiatives

• Documents and investigates quality events associated with contamination control of commercial manufacturing to ensure effective root-cause analysis, corrective action plans determination, product impact, and remediation.

• May develop and deliver microbial control training.

• Prepares reports and metrics by collecting, analyzing, and summarizing information and trends.

• Makes decisions; develops and implements policies.

• Implements preventive and corrective actions to enhance clean room controls.

• Participates in regulatory inspections and any required follow up actions.

• Ability to foster working relationships between multiple departments of Regeneron in support of bulk manufacturing microbial control efforts.

Education and Experience:

• Bachelors degree in Microbiology, Biology or related field and 3+ years of relevant cGMP manufacturing experience.

• Knowledge and experience in pharmaceutical microbiology, cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.