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Director CMC Development PRTL Packaging & Device US

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois and will require work in the office.

Purpose and Scope:

The Director provides strategic leadership, policies, and advanced technical expertise for the Pharmaceutical Research & Technology Labs (PRTL) Packaging & Device Department, leveraging areas of specialization such as technology, design, and process development for packaging and devices.

The incumbent will provide strategic and technical leadership while creating multi-country packaging strategies and policies for the Americas. As a member of global CMC teams, this person will lead all aspects of package material selection, design, commercial readiness, and process improvement for regional products. They will interface with professional organizations and industry peers to maintain awareness of current and emerging packaging technologies and the latest regulatory requirements.

Essential Job Responsibilities:

+ Provides leadership, and guidance to direct reports and project team members in an effort to develop strong leaders at Astellas. This position manages a department of 2 to 3 direct reports.

+ Directs and maintains a packaging technology strategy for products sold in North, Central and South America. Packaging strategy will support Marketing, Sales, and Supply Chain strategies to ensure company policies for patient safety and risk management are met.

+ Direct and lead product packaging design, packaging process development, commercial production activities and reliable supply of products based on criteria of product protection, marketing considerations, manufacturing requirements, user convenience, material costs and availability in conjunction with the CMO and packaging manufacturer, and serve as an escalation point for complex, high impact manufacturing issues and decisions.

+ Creates and implements packaging and device procedures and standards to meet regulatory and FDA requirements. Must keep current with laws and changes in international and domestic government policies and develop strategies for compliance.

+ Directs and maintains Device/Combination product development strategy following current regulations for product realization.

+ Maintains high degree of knowledge with all forms of Cold Chain packaging and associated distribution methods to support various Cold Chain Packaging systems.

+ Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; component suppliers, contract packers, third party logistics, product strategy leads, Quality Assurance, Procurement, Business Development, Research and Brand teams.

Qualifications:

Required

+ Bachelor’s degree in Package Engineering, Mechanical Engineering or Chemical Engineering.

+ Minimum 10 years of experience, with increasing responsibilities, in Package Engineering or related field.

+ In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution, and take action.

+ Working knowledge of the combination product quality system regulations, such as 21 CFR Part 4, and other GxP regulations as applicable.

+ Demonstrated project management and leadership skills.

+ Demonstrates extensive knowledge of industry best practices and trends.

+ Must have excellent analytical, problem-solving and communication skills to deal with all levels of the organization.

+ Demonstrate a high degree of ingenuity, creativity, and innovativeness to develop solutions to complex problems.

+ Professional Memberships: Experience in leading in industry activities outside the company (e.g. Drug and Pharmaceutical Packaging Committee).

Preferred:

+ Master’s degree in technical or business is preferred.

+ Pharmaceutical GMP & GDP experience a plus.

Working Environment:

+ This position is based in Northbrook, IL, USA.

+ Working in office, basically.

+ Up to 10% travel, domestic and international, may be required.

**Salary Range** **:** $170,450 - $243,500 (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

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Category Pharmaceutical Research and Technology Labs.

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans