Shire Jobs

Manufacturing Manager

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Senior Manager, Operations & Production Maintenance,

Ensures delivery of the annual production schedule of a 3-shift operation, producing quality products within standard costs, and assuring staffing plans are met for immediate and long-term success of the department. (Unit Dose, Multi-Dose and Manufacturing) In addition, incumbents will: develop team based operational systems and processes to optimize performance, reduce cycle times and production costs and drive First Time Right improvements (Lean Manufacturing); develop self-directed work teams and an environment conducive to high performance; review and approve procedures and ensure training is administered to drive compliance to GMPs; manage/participate and approve problem investigations, corrective actions and audit responses etc. to assure compliance and resolution within due dates; manage adherence to safety, OSHA and company policies; manage financial indices such as budget and labor standards; implement processes to ensure development and performance improvement of staff.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Production Processes that Consistently Meet Standards for Quality, Cost and Safety (30%):

• Represents Operations in the pre-S&OP process to ensure production plans meet current and future requirements and reflect non-commercial activities that would impact the production schedule

• Drives root cause resolution to production issues and monitors upcoming production schedules to resolve conflicts and drive efficiency.

Ensures that appropriate levels of trained resources are available to meet production schedules.

• Proactively identifies, assesses, and mitigates operational and organizational risks; escalates key risks and issues to manufacturing senior management and cross-functional support teams.

• Drives reduction in waste and increases in efficiency by establishing performance and cost standards, measuring against those standards, and driving real improvement.

• Analyzes people capacity required to respond to changing market demands and develops strategies to ensure Operations is able to effectively deliver the right people with the right skills in the right place at the right time.

• Adheres to capital and expense budgets, as well as drives cost reduction opportunities.

• Oversees the production process, creating a schedule; adjusting schedules as needed.

• Develops and tracks improvement in reduction of planned direct labor hours.

• Manages the adherence to prescribed procedures to ensure first pass quality meets or exceeds planned goals.

Skills & Performance of People Are Appropriate for Business Needs (25%) :

• Ensures self and staff understand the organization’s vision, values, goals and strategies and their relationship to their daily work.

• Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.

• Helps others to successfully manage organizational change. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.

• Understands HR policies and practices and uses them to manage employees.

• Ensures money, technology, and staff are allocated to achieve optimal results.

• Ensures self and staff keep up to date on technical knowledge and developments that impact roles. Uses this information to drive improvements and/or prepare for changing requirements.

• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.

Effective & Efficient Production Processes (25%)

• Coordinates, sets up and implements standard operating procedures for all production operations. Develops quantitative techniques to monitor process performance.

• Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.

• Ensures development of operational systems and processes to optimize performance, reduce cycle times, production costs, and drive OEE improvements. (Lean Manufacturing).

• Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.

• Ensures stakeholders are appropriately trained on the process and any process changes.

Culture of GMP Compliance & Safety (20%)

• Follows all GMP and HSSE rules and regulations. Accepts accountability for compliance and personal safety and ensures that the employees under his/her supervision are complying with all HSSE requirements.

• Supports all company GMP, Compliance, and safety initiatives and assures compliance with company safety policies, procedures and OSHA safety regulations. Resolves safety problems as required, investigates accidents and resolves at root cause level, supports and / or leads safety training and related safety requirements. Participates in safety inspections as required.

• Complies with and assists in enforcing all site security requirements.

• Assists in ensuring that site activities do not create a negative impact on the environment.

  Your profile

EDUCATION & EXPERIENCE:

• Bachelor’s Degree in Business, Logistics or related field (MBA or MS preferred)

• At least 8 years related manufacturing leadership experience, preferably in a pharmaceutical, food, or other regulated environment; or equivalent combination of education and experience, preferably FDA/GMP

KNOWLEDGE SKILLS & ABILITIES:

• Strong, proven leadership, technical, business, problem solving, and managerial skills.

• Strong, proven written and oral communications and interpersonal skills required.

• Demonstrated planning and organizing skills, operational decision-making ability, adaptability, and ability to build strategic relationships and facilitate change.

SCOPE OF DECISION-MAKING: Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

LEVEL OF SUPERVISION PROVIDED: Direct supervision responsibility, including performance assessments, of more than 10 employees.

INTERNAL / EXTERNAL CONTACTS: Regular inside and outside: Requires contacts to carry out company policy and programs. Improper handling will have considerable effect on operating results. Must often deal with persons of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.

PHYSICAL REQUIREMENTS/ENVIRONMENT:

While performing the duties of this job, the employee is regularly required to sit; use hands to handle or feel objects; reach with hands and arms. Specific vision abilities include close vision and ability to adjust focus. The employee must occasionally lift and/or move up to 10 pounds

Compensation range

90,000.00 - 110,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!