Sr Dir, Manufacturing Operations

POSITION SUMMARY: This is a senior leadership position for a multi dose form pharmaceutical manufacturing facility focused on parenteral and solid oral dose manufacturing. This position is a key leader in developing manufacturing strategy and leading high functioning teams in a cross functional, fast-paced environment.
Major Responsibilities
Major Responsibilities
Estimate percentage of time spent on each responsibility

• Provides strategic leadership to bulk formulation, sterile filling and inspection, and solid oral dose manufacturing functions, focused on safety in operations, product quality, efficiency, and compliance.

20%

• Identify, prioritize, and implement key manufacturing systems, policies and projects to ensure all products manufactured meet critical quality attributes and specifications right first time, and successfully collaborate cross-functionally to ensure each operational unit has the appropriate resource support to ensure success.

10%

• Refine systems and processes that track and optimize productivity and standards, metrics and performance targets. Lead continuous improvement and operational excellence efforts across the manufacturing organization

10%

• Prepare budgets and forecasts; oversee financial discipline across the manufacturing organization. Monitor plant performance to budget through appropriate KPIs

10%

• Motivate and lead a high-performance management team, focused on the development of people and a collaborative culture. Identify and prioritize hiring requirements, including analysis of specific skill sets and competencies required for the plant.

20%

• Ensure collaboration with internal and external stakeholders, for successful and timely transfer of products and processes to commercial manufacturing

30%
Academic/Technical Qualifications
Bachelor’s degree in an engineering or science discipline required; Master’s Degree Preferred
Specialist/Technical Qualifications/Knowledge
Strong understanding of and experience in parenteral drug manufacturing within the pharmaceutical or similar regulated industry
Experience (type, Level, Extent, Etc.)

• Capable of interaction at all levels of the organization
• Proven strategic leadership and enterprise mindset
• Strong people management and influencing experience, with exempt and non-exempt employees
• Ability to manage and execute several activities at once
• Proven track record in delivering culture transformation
• At least 15 years’ experience in pharmaceutical manufacturing management roles, gained within a commercial pharmaceutical manufacturing environment or equivalent GMP management experience
• Clear concise logical thought processes
• High level of financial acuity
• Strong project management abilities
• Thorough knowledge of cGMPs

EXTERNAL FOCUS: PATIENTS, SHAREHOLDERS

• Able to work effectively in a matrixed organizational structure
• Consistently search for ways to improve the level of service provided
• High level of customer orientation/understanding
• Understands constituents’ needs and expectations while maintaining a focus on the business

Physical Requirements
Position could include standing for extended periods of time, lifting heavy objects & repetitive tasks
#Hybrid
About Us
Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.