Manages multi-disciplined teams of exempt and non-exempt members in a factory area to ensure all manufacturing systems, production processes, equipment, and final pharmaceutical products meet or exceed Alkermes manufacturing standards and regulatory requirements, and business objectives

MAJOR RESPONSIBILITIES

• Leads decision-making and achievement of goals and objectives for assigned manufacturing area by applying thorough business knowledge, expert technical leadership, and successful team management skills.
• Uses internal resources judiciously; facilitates the identification of manufacturing priorities and improvements quickly, and challenges area members to work together to achieve them efficiently and cost-effectively, in compliance with cGMPs and regulatory requirements.
• Initiates relationships with internal and external customers and support functions that build trust and confidence.
• Provides timely, concise written and oral communications to Pharmaceutical management to ensure a clear understanding of recommendations, ongoing operating conditions, achievement of area goals and objectives, and performance versus administrative budgets/forecasts.
• Identifies training needs and ensures timely, up-to-date training as required.
• Ensures ongoing performance dialogue, coaching, and mentoring among members.
• Establishes performance measures and metrics that are clear “visual” expectations.
• Communicates business, focus factory, and area performance trends in a timely manner to enhance motivation.
• Recommends meaningful rewards for superior contributions to the business in accordance with Alkermes policies.
• Participates in developing and integrating new technology/manufacturing innovations/new products that support the business's strategic goals.
• Communicates and ensures a thorough understanding of area objectives, production schedules, operating procedures, and manufacturing issues.
• Makes daily visits to production lines or participates in unit work group meetings to monitor activities on the floor and accomplishment of area objectives, uncover and resolve issues, and lead the department’s productivity programs.
• Leads daily Inventory Review meetings and works with Planner/Scheduler to ensure timely availability of products at optimum cost and effective production scheduling.
• Monitors all operations and manufacturing data and reports evaluates deviations and trends to assure the quality and integrity of equipment, processes, and final products
• Coordinates analyzing and evaluating the area’s production processes and equipment. Works in conjunction with Process Engineer and manufacturing leaders in the development of recommendations for resolving daily production/equipment/staffing issues, improving equipment and processes, and establishing appropriate measures and metrics.
• Proactively interacts with support functions to ensure effective operations (e.g., Quality Management, Purchasing, Engineering and Maintenance, Accounting, Human Resources)
• Interacts with internal and external customers to achieve the department’s business objectives.
• Supports the Manager, Site Operations, and Process Engineering and takes a leadership role in developing and integrating new technology/manufacturing innovations/new products that support the business's strategic goals.  Leads the development and implementation as it relates to factory area.
• Leads the development of area goals and objectives.  Manages the implementation of goals and objectives as related to area.
• Works closely with the Engineering and Finance liaison in developing cost estimates and preparing capital and expense budgets related to the area. 

COMPETENCIES

• Skills and knowledge in Project Management
• Communication skills with technical professionals
• Excellent organizational skills
• Ability to self-manage and prioritize workload
• Ability to supervise a broad range of personnel
• Ability to react quickly to understand and solve problems
• Excellent troubleshooting skills
• Positive management attitude

Physical Requirements:

• Occasional periods of repetitive motion.
• Ability to gown in an aseptic manner for clean room operations. 
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. 
• Ability to operate all types of production equipment 
• Ability to read, understand, and follow company SOP guidelines.
• Ability to lift/move up to 50 lbs.  Ability to team lift up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hrs. 

EDUCATION AND EXPERIENCE

Basic Requirements

• High School Diploma or equivalent.
• 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
• 5 years experience, preferably in pharmaceutical manufacturing or other regulated industry.

Preferred Requirements

• Bachelor’s Degree in engineering/scientific discipline or the equivalent
• 10 years of pharmaceutical production experience, including six years of related supervisory experience.

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