Director, Manufacturing at Alkermes, Inc. in Wilmington, OH

GENERAL DESCRIPTION:

This position has leadership and managerial responsibility and accountability for the filling and formulation manufacturing units for the Wilmington, Ohio site. This accountability is focused in the key areas of Compliance, Productivity, Quality and Safety as they relate to the manufacturing operations. This position has the authority and responsibility to work with the Site Leadership Team members to establish goals, acquire the resources and achieve the objectives to accomplish new levels of performance in this area.

KEY DUTIES:

Defines goals and objective of the manufacturing units
Uses teamwork to build productive links between and among the operations and support departments
Establishes and executes initiatives to develop and build the capabilities of the operations management and manufacturing teams
Work collaboratively within the Operations and Quality units to improve and enhance the compliance systems
Uses measurement system and metrics to continually monitor performance in key areas
Influences, motivates and aligns individual project teams and all support groups in support of manufacturing operations goals and objectives
Ability to lead through engagement and communication
Ability to assess and develop talent
Ability to create a vision, align engage and execute
Financial acumen (basic to advanced understanding of P& L)
Change management skills required in a rapidly growing organization
Champions Operational Excellence and continuous improvement activities
Accessibility to work force/high frequency of engagement to employees

PERSONAL ATTRIBUTES:

A consummate leader, able to train, motivate and upgrade a rapidly changing organization
Ability to work alongside cross-functional team members as a day-to-day partner in driving the quality culture
Capable of building authentic relationships with multiple constituencies
Possess the patience and ingenuity to raise the profile of manufacturing both inside and outside the company
A strong leader, committed to winning long-term success through consistent focus on innovation and on the best possible use of resources, both human and technological, in the manufacturing function

EDUCATION AND EXPERIENCE:

BS in Engineering, Business, or Life Sciences (Biology, Chemistry, etc.) or adjacent.
Minimum of 10 years pharmaceuticals production experience, to include five years related supervisory experience, with at least 2 years of leadership of people leaders.
Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
Thorough knowledge of cGMPs and regulatory guidance requirements (FDA, EMA, PIC/S, etc.).
Previous leadership of commercial GMP manufacturing operation required. FDA and/or other global regulatory inspection experience highly desirable.
Up to 10% travel expected.

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.