Materials Specialist (External Manufacturing)
Job Details
Full Job Description
Within this role you will collaborate with the team to ensure business objectives are met through effective support of Drug Product manufacturing activities. Your remit will include organizing and driving critical Drug Product Manufacturing requirements to ensure world-class performance of IOPS (Industrial Operations & Product Supply).
As a Materials Specialist a typical day might include, but is not limited to, the following:
Providing support to the operations team ensuring world-class DP supply quality, delivery and efficiency
Coordinating logistic documentation enabling shipments
Driving compliance activities including but not limited to, changing controls, investigations and CAPA’s
Managing audit CAPA closure
Maintaining, updating and providing the status of activities via schedules and checklists
Reviewing manufacturing records
Tracking, trending and supervising information and data; preparing reports and analysing operations data
Driving continuous improvement of operation systems and processes
This role might be for you if:
You demonstrate proficient skills in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
You have strong interpersonal, written and oral communication skills
You show resilience and flexibility in the face of challenges and adversarial situations
You have proven capability to understand and listen to team members and partners needs while supporting productive team environments toward a common objective
To be considered for this opportunity you should have a BS/BA in scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or equivalent combination of education and experience. A Senior Specialist should have a minimum of BS/BA in scientific or engineering discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
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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.