Open Position

Senior Manager, Operations & Production Maintenance

Unither Pharma - Rochester, New York, United States (On-site)

JOB SUMMARY:

The Senior Manager of Operations and Production Maintenance provides strong and direct hands-on leadership to Operations and Production Maintenance staff to focus on Customer Satisfaction and Operational Efficiency using thoughtful planning execution, effective communications, dynamic and responsive organization, and accurate execution of commitments. In order to support our opportunities for market growth, the Senior Manager of Operations and Production Maintenance establishes systems to ensure service level issues are prevented and/or resolved on a timely basis while also improving throughput capacity to meet rising customer demand. Critical to success in the role is the ability to meet customer expectations while managing and improving line efficiencies, lead-time, reducing waste, reducing “bottlenecks”, improving material utilization, improving internal project due dates to assure the meeting of customer due dates. This key impact role will serve as strategic and tactical business partner within the organization and change agent by directing planning and execution methods while maintaining and optimizing the efficiency, quality and safety of the production process.

 

ESSENTIAL FUNCTIONS / RESPONSIBILITIES / ACHIEVMENT MEASURES:

Ensure Customer Satisfaction

  • Deliver the ordered quantities within the requested delivery dates of all customers to meet or overachieve our contractual commitments.
  • Measure and evaluate his team regarding to the standard production lead-time and the Documentation Right-First-Time expectation
  • Ensure the quality level of the products is confirmed to cGMP Standards and negotiated customers’ requirements
  • Successfully pass all customers and authorities inspections and audits repetitively
  • Execute the production schedule provided by the Supply Chain department and organize all the means under his responsibility, including shifts and people availability to guarantee a level of adhesion of at least 95%.
  • Collaborate closely with the Product Development department and organize all the necessary means (resources, line, equipment…) to support the production of development products on-time while maintaining a commercial production schedule to satisfy the other customers.
  • Ensure the efficiency, productivity and profitability of all the areas under his/her responsibility
  • Reduce non-Quality and guarantees Achievement of the contractual products Right-First-Time

 

Effective & Efficient Operations

  • Ensure the efficiency, productivity and profitability of all the areas under his/her responsibility
  • Create, challenge and implement standard operating procedures for all production operations. Develops quantitative techniques to track and monitor process performance.
  • Ensure development of operational systems and processes to optimize performance, reduce cycle times, production costs, and drive OEE improvements. (Lean Manufacturing).
  • Apply existing SOPs and Technical procedures while evaluating their effectiveness, identifies changes that would enhance the process, propose them and implement them once approved by Quality.
  • Ensure stakeholders are appropriately and regularly trained and qualified to empower employees and increase accountability.
  • Manage and arbitrate operations, production maintenance to continuously use efficiently all the production lines, increase OEE, reduce downtime and support the customer demand.
  • Ensure compliance with the productivity performance of the different lines
  • Develop, using training, knowledge transfer and empowerment, the appropriate autonomy of the operators (ex: Changeover, Sampling, Testing, Maintenance Level 1…) to drive continuous improvement
  • Define, implement and periodically review with the Production Maintenance, Engineering and Operations the appropriate Preventive and Curative Maintenance plan
  • Define and deploy a Continuous Improvement approach and process with reporting (based on data and analytics) to support the action plans and demonstrate the results.
  • Develop, maintain and communicate to appropriate levels, KPI allowing for the making and execution of SMART business decisions for continuous improvement.
  • Builds, Tracks and Manages its operating and investment budget according to the site Master Plan once approved
  • Propose productivity ideas and improvement plans while developing his budget
  • Identify and actively work on reducing yield losses in general and especially high-value price active ingredients and components.

 

Culture of GMP Compliance & Safety

  • Manage processes according to the cGMP and the Site Quality Management System
  • Follow all cGMP and HSSE rules and regulations, leads by example, and holds others to the same.
  • Accept accountability for compliance and personal safety and ensures that the employees under his/her supervision are complying with all HSSE and cGMP requirements.
  • Support and assure compliance to cGMP, compliance, safety regulations, policies, procedures to obtain no critical observations during audits and inspections.
  • Utilize understanding of regulatory environment and industry trends to identify ways to improve quality and compliance.
  • Manage all the changes that may have a regulatory impact, on the quality of products manufactured and on the control of critical parameters
  • In collaboration with Validation, control the parameters of the critical equipment and ensure their traceability on a continuous basis.
  • Ensure complete traceability of maintenance intervention and information/ Ensure documentation compliance and traceability of adjustment or modification on equipment
  • Coordinate and ensures the closure, within time, of the quality investigations following a malfunction of equipment and / or during production
  • Ensure the application of 5S on the floor and the compliance post audits
  • Strictly respect the CAPA deadlines for regulatory and customer audits as approved with Quality
  • Resolve safety problems as required, investigate accidents using root cause analysis and fishbones and resolve at root cause level, support and / or lead safety training and related safety requirements.
  • Participate in safety inspections as required.
  • Comply with and assists in enforcing all site security requirements.
  • Assist in ensuring that site activities do not create a negative impact on the environment.

 

Production Capability Meets Current and Future Customer Requirements

  • Translate the company strategy into multi-year operational strategies that anticipates the evolution and future of the business
  • Represent Operations in the S&OP and Production Plan process to ensure production plans and capacity meet current and future demand, including non-commercial activities that could impact the production schedule.
  • Propose planning adjustment as necessary to be more coherent with the equipment performance
  • Target business activities against strategic priorities to achieve maximum quality, cost and customer service. Drives assessment and upgrading of equipment in pursuit of continuous improvement.
  • Maintain and foster communication between Quality, Engineering, Product Development, Supply Chain and the Operations group to ensure that orders are filled, and that product meets customer requirements in terms of quality, quantity, consistency, and timeliness.
  • Participate in new business technical feasibility assessments by participating in the preparation of new business or customer proposals and facilitate successful new product launches by leading the production strategy for onboarding new projects/products.
  • Provide appropriate support to the Engineering, Validation, Qualification and Metrology departments during the development and implementation of new equipment on site but also on during routine activities on existing equipment by ensuring appropriate operations and maintenance resources are available in a timely manner.

 

Skills & Performance of People Are Appropriate for Business Needs

  • Ensures self and staff understand, unite and align with the company’s values and apply them in their daily work.
  • Ensures the adequacy of trainings/qualification of his team based on their roles and missions
  • Développer les compétences et l’autonomie de l’équipe
  • Develop team skills and autonomy
  • Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals during performance reviews; providing clear, thorough, timely feedback; and addressing and documenting performance problems and issues promptly.
  • Acts as a champion for change. Facilitates the implementation and acceptance of change within the workplace.
  • Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
  • Understands and follows HR policies and practices and uses them to manage employees.
  • Uses information and data to drive improvements and/or prepare for changing requirements.
  • Analyzes the skills and capabilities of his areas of responsibilities; identifies future workforce requirements, needed training; and close any gaps in collaboration with HR Department.
  • Develops an organizational structure that supports the retention and development of staff to deliver a high level of performance, as well as offers career development for high performers/ high potentials.
  • Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization to engage employees and define priorities and goals as needed

 

EDUCATION & EXPERIENCE:

  • Bachelor’s Degree in Chemistry, Biology, Pharmacy, Engineering or related field required; Masters preferred
  • Minimum 15-year experience in FDA or other regulatory agency environment.
  • A minimum of 10 years in a leadership/management position in Operations
  • A minimum of 3 years in a Supply Chain management role
  • Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background.
  • Experience in audits and regulatory inspection including PAI.
  • Experience in aseptic manufacturing, filling, and packaging, facility operation, and quality systems.

 

KNOWLEDGE SKILLS & ABILITIES: 

  • Must be fluent in the country language
  • Knowledge of aseptic manufacturing and filling
  • Knowledge of manufacturing and packaging in a pharmaceutical operation
  • Knowledge of production planning and S&OP process
  • Knowledge of Lean and Operational Excellence applications in the pharma industry
  • Knowledge of cGMP and FDA and International regulations

 

SCOPE OF DECISION-MAKING: Decisions require complex analytical judgment.  Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities and including their application to cases not routinely covered.  Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.

 

LEVEL OF SUPERVISION PROVIDED: Direct supervision responsibility, including performance assessments, of less 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:

  • Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
  • Must be able to work on a computer for extended periods of time.
  • Must wear safety glasses and other protective items as required.
  • Sitting 55% of the day; standing or walking 45%.

 

COMPANY VALUES and EXPECTED BEHAVIOR

 

EXPECTED BEHAVIORS

 

VALUE BEHAVIOR DEFINITION
Courage Direct Unambiguous, Straightforward and loyal behavior
True Communicates information that reflects reality; willingness to be exact and objective.
Responsibility Involved Puts all his/her energy into the success of the company, including departments and projects.
Accountable Demonstrated will and courage to ensure and defend all decisions.
Trust  

Positive

 

Prioritize what is right; exhibits constructive behaviors.
Partner Works autonomously, cooperates and collaborates within a team environment; empowers employees to do their best.
Innovation New Ways Embraces change, understands and effectively seeks out continuous improvement and proposes solutions to problems.
Curious Eager to know or learn more, beyond their regular duties.
Respect  

Fair

 

Demonstrated willingness to be impartial.
Open Minded Willingness to listen to others’ ideas and concerns.

 

Salary range: 145-180k

 

This job description is a summary of the job duties and requirements that represent the general nature and level of work being performed.  This description is not intended to limit or in any way modify the right of management to assign, direct and control the work of employees.  In addition to the above, all employees are expected to read, understand, and comply with company policies and procedures, regulatory expectations, HSE requirements, quality and department standards, etc.  Although certain positions have specific tasks and responsibilities with respect to pharmaceutical quality and safety, the safety and quality of all products manufactured by Unither Manufacturing LLC and the Health and Safety of all persons on-site is, in general, the responsibility of every employee.

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