Assoc Mgr Serialization, External Mfg
We are currently looking to fill an Associate Manager - Serialization in External Manufacturing Project Management (EM PM) with a 1st shift, Monday-Friday, 8:00 am-4:30 pm schedule. Regeneron manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Associate Managers in serialization are instrumental to ensure compliance to serialization regulations required for producing these life changing products.
As an Associate Manager Serialization, a typical day might include the following:
Facilitates cross-functional teams and manages the planning and execution of deliverables for the assigned serialization projects as required in the US Drug Supply Chain Securities Act (DSCSA) and EU Falsified Medicines Directive (FMD) including EMVOs NMVOs
Leads sub-projects and prioritizes using excellent interpersonal, communication and time management skills
Drive efforts to improve business processes through gap assessments and continuous improvement including creation of new policies, SOPs, technical assessments and work instructions, etc.
May facilitates regular project focused meetings with CMO/partners and internal working teams and ensures meeting minutes and weekly/monthly reports are completed accurately
Provide subject matter expertise for serialization as related to packaging and distribution processes, including line serialization systems like Optel or Systech.
Partner with IT on system integrations, maintenance and system validations including validation documentations of serialization interfaces with various partners (CMOs, 3PLs, Distributors, Internal Packaging).
Collaborate with business users to remain current on business requirements, identify potential automation / system solutions and suggest configuration changes and improvements to existing systems.
This role might be for you if you are/have:
Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills qualification
Proficient in advanced techniques with relevant software: MS Project, MS Excel & PowerPoint, etc. in addition to experience working within shared work environments (OneDrive, Sharepoint, Team, OneNote, etc.)
Proven self-starter; quick learner
Basic understanding of all aspects of serialization as it applies to product identification per related guidance (FDA, HDA, EU) while remaining current with changes in regulations.
Basic knowledge of serialization requirements, regulations, systems such as Systech and Optel and administration within a global supply chain network.
Tracelink System experience (end to end) preferred
Proficiency in analysis of serialization data transfer from manufacturer to 3PLs preferred.
GS1 Standards, EPCIS, HDA Standards preferred.
To be considered for the Manager Serialization position you must have the following;
Bachelor’s degree in Business, Information Systems or a scientific subject area and 5 years of demonstrated ability in pharmaceutical/biotech/manufacturing Supply Chain environment or equivalent combination of education and experience.
PMP certification or MBA a plus.
Lean/Six Sigma experience a plus.
APICS-CPIM, CSCP, or CPSM certification a plus.
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.