We are currently looking to fill a Materials Specialist-External Manufacturing position. The Materials Specialist-External Manufacturing is a key member of an External Manufacturing Team who collaborates with various departments and manufacturing partners to ensure on-time delivery of materials and on-time production and release of parenteral medicines. This role works with minimal supervision, proactively identifies and resolves issues that could impact production schedules and can identify and implement meaningful changes.
In this role, a typical day might include the following:
External Manufacturing subject matter expert for Oracle to process CMO Quotes (Project Plans/Work Orders) and invoices, tracking the status of PO approval.
Maintains critical databases and ensures accuracy and integrity of the data.
Generates reports necessary to manage production activities and provides input on key decisions.
Ensure accessible history of allocations, knowledge of material consumptions and calculates manufacturing yields in Oracle and other designated systems.
Tracks, trends and monitors a wide variety of External Manufacturing data; prepares reports analyzing data and makes recommendations proactively with minimal supervision.
Collaborates directly with CMOs and relevant internal stakeholders to resolve errors and questions on invoices.
Leads and supports Continuous Improvement initiatives to improve efficiency and quality of processes and operations.
Identifies problems and takes the initiative to resolve them.
Collaborates with relevant internal stakeholders in coordinating shipments and ensures on-time deliveries.
Participates in key projects with the expectation to lead initiatives with increased importance to the EM organization.
Supports investigations if needed in accordance with Regeneron requirements.
May travel to contractor sites (>10%).
This role might be for you if:
Proficient in Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments (i.e. SharePoint, Box, eRoom).
Exhibits confidence and has strong interpersonal, written and oral communication skills for providing team updates.
Gains understanding from provided instructions and works towards goals with minimal supervision.
Experience working within GMP/Quality systems. Oracle
Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
Understands and listens to team members and stakeholders needs while supporting productive team environments toward one common objective.
Shows flexibility and willingness to collaborate in the face of challenges and adversarial situations.
To be considered for the Associate Specialist you must have a BS/BA or equivalent combination of education and experience. To be considered for the Specialist you must have a BS/BA and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or equivalent combination of education and experience. To be considered for the Senior Specialist you must have a BS/BA and 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) 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, 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.
Salary Range (annually)
$59,700.00 - $126,800.00