Manager Drug Product MFG Planning & Scheduling

Location
Rensselaer, NY, United States
Posted
Jun 27, 2019
Ref
16118BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The Manager of Drug Product Manufacturing Planning and Scheduling is accountable for all global clinical and commercial drug product manufacturing planning and scheduling. 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 leader will solely and/or manage and develop a global team of production schedulers that, collaborate with CMOs as well as internal manufacturing operations, own S&OP processes with strategic manufacturing partners, ensure manufacturing readiness milestones.

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

• Accountable for the global Drug Product Manufacturing production planning and scheduling through external and internal manufacturing network.

• Serve as a liaison representing DP Manufacturing in the S&OP process. Utilize manufacturing network to deliver the production requirements needed for drug product, device assembly and final package.

• Implement systems and analyze reports that track and measure production readiness and supply metrics, component and WIP inventories to meet defined safety stock targets, track the progression of every DP lot through disposition and ensure global/region capacity meets production requirements in the short and long terms for both clinical and commercial medicines.

• Monitor metrics and key performance indicators for CMOs and Partner Manufacturing sites to ensure timely supply is available to support clinical and commercial medicines.

• Implement, own and continuously improve the S&OP process with strategic CMOs and Partner Manufacturing sites.

• May lead high performing production planning and scheduling teams that are well versed in DP manufacturing processes, integrated in the DP Manufacturing and DP Project teams and appropriately trained in all relevant systems and procedures.

• Partner with internal stakeholders to quickly assess supply constraints, communicate mitigation plans and ensure that production schedules are in alignment with IOPS priorities.

• Support and collaborate with the Drug Product Project Management, Quality Assurance and Compliance organizations to ensure accurate scheduling of manufacturing activities in support of technical transfers, process validations within the global DP Manufacturing network.

• Drive and manage departmental and individual expectations; provide direction and balanced performance feedback; coach, develop, and challenge direct reports, uphold all company policies and serve as a leading example of Regeneron 5 and IOPS Success Factors.

• Actively participate on departmental and site teams to improve and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.

• Ensure adequate resources are dedicated to correcting important or critical issues via personal involvement, delegated resources, and/or appropriate escalation internally and externally.

• Provide support to various functions within Drug Product Manufacturing.

Knowledge, Skills, and Abilities:

• Demonstrated manager with expert knowledge of GMP production planning and scheduling processes for parenteral manufacturing, device assembly and finished label and package.

• Demonstrated building of internal and external partnerships, efficient at identifying and removing barriers for team and projects, and effective at communicating to a wide audience of experience, skills and expertise.

• Knowledge of Enterprise Resource Planning systems (Oracle preferred).

• Knowledge of manufacturing and quality operations for parenteral medicines.

• Knowledge of the challenges and lead times involved when transferring aseptic parenteral filling, device assembly and finish label & pack operations or equivalent manufacturing processes.

• Knowledge and experience in planning and scheduling the manufacturing of aseptic parenteral filling, device assembly and finish label & pack operations or equivalent manufacturing processes.

• Experience with collaborating with Contract Manufacturing Organizations and strategic partners. Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)

• Strong project management, interpersonal, cross- cultural, communication, negotiation and problem-solving skills qualification preferable.

• APICS, ISM, ASQ or SME professional certification preferred.

• Ability to travel 25% (domestic and international).

• Fluent in English with a preference given to candidates with competencies in German, French and/or Spanish (oral and written).

• The ability to think strategically while being able to quickly adapt to emerging situations.

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Education and Experience:

• Requires minimum BS in an engineering, business or scientific discipline with minimum of 7 years of related experience in manufacturing production planning or similar experience, preferably in biopharmaceutical cGMP environment.

• 3 to 5 years of management and/or leadership experience required.

Level of manager determined based upon experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.