Description

We are currently looking to fill a Director of External Manufacturing (EM) Planning. The Director of External Manufacturing Planning is accountable for global clinical and commercial manufacturing planning and scheduling, logistics coordination, and EM systems (i.e., ERP). This is a global leadership role with teams located in US and EU with the primary focus of delivering clinical and commercial medicines to all patients on-time and in-full. The Associate Director builds and develops a global team of production schedulers that collaborates with CMOs as well as internal manufacturing operations, owns S&OP processes with strategic manufacturing partners and ensures manufacturing readiness milestones.

A typical day in this role may include the following:

Accountable for the global External Manufacturing production planning and scheduling through external and internal manufacturing network.
Establishes and maintains a strategic plan for the External Manufacturing department in support of activity requested by the business, including supporting a business continuity plan to ensure continued external production during disruptive local or worldwide events.
Develops and implements systems and reports that track and measure production readiness and supply metrics, component and WIP inventories meet defined safety stock targets, track the progression of every externally manufactured lot through release and ensure global capacity meets production requirements in the short and long terms for both clinical and commercial medicines.
Leads the Logistics area to ensure material is shipped in a timely manner to meet finished goods delivery dates and/or downstream activities.
Supports and collaborates with the External Manufacturing Project Management and Quality Assurance organizations to ensure accurate scheduling of manufacturing activities in support of technical transfers, process validations and CapEx project executions within the global External Manufacturing network.
Travel up to 25% (domestic and international), as required.

This role might be a fit for you if:

Demonstrated leader with expert knowledge of GMP production planning and scheduling processes for parenteral manufacturing, device assembly and finished label and package.
Deep knowledge ERP systems (Oracle preferred).
Knowledge of the challenges and lead times involved when transferring aseptic parenteral filling, device assembly and finish label & pack operations.
Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.).
APICS, ISM, ASQ or SME professional certification preferred.
Competencies in German, French and/or Spanish (oral and written) preferred.

To be considered for the role you must have a BS/BA in a scientific discipline and 10 years of related experience in a biopharmaceutical cGMP environment, including 5 years management and/or leadership experience, or equivalent combination of education and experience. A MSc/MBA is a plus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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)

$172,200.00 - $286,900.00

Director External Manufacturing Planning

Description

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