Director Manufacturing, (Operations Technical)
Do you want to help a company evolve. Are you excited for new challenges. Do you have technical and operational leadership experience and can demonstrate success manging both Technical and Operational functions.
As part of the Site Leadership Team, this role will contribute to the future direction and success of our UK site in Maidstone, Kent; positioning it as the partner of choice for pharmaceutical and biotechnology companies wishing to develop and produce their proteins in microbial systems.
Oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Develops and recommends manufacturing policies, procedures and programs. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times. Prepares documentation, reports and standard operating procedures as required. Ensures the effective use of materials, equipment and employees in producing quality products. Senior Management will monitor and control labor, capital expenditures and develop budgets. May act as the primary contact for the business unit. May manage one or more manufacturing functions.
Will perform some or all of the following:
- Establish and manage a strategic direction for all areas of responsibility, including plans for future growth that align with company broad business objectives; act as the decision maker to achieve goals and objectives critical to the success of the facility and assigned functions
- Provide leadership expertise to the R&D (Process Development) Technical Operations (Process Scale Up and Transfer) departments, including development and implementation of strategy and technologies to build technical capability required to achieve BioPharma CDMO business
- Oversee all assets at location to ensure maximum utilization and the timely delivery of quality products and customer projects, including to cGMP standards applicable for Biologic drug substance programs
- Plan, prepare and recommend an annual operating budget overseeing all accounting and reporting for location capital assets; implement a monitoring system to analyze facility performance against budget; oversea activities of Engineering & Maintenance group with the aim of developing and maintaining facilities, equipment, and utilities to meet the needs of the business
- Provide direction and support to department leaders to develop goals and objectives in line with facility goals, ensure career development plans for employees, training, development, and performance management
- Evaluate manufacturing systems, methods, procedures, and controls with a focus on continuous improvement and achieving and sustaining MHRA cGMP certification and manufacturing license
- Facilitate cooperation between Sales, Operations and Finance in coordination with Supply Chain, other facilities and outside vendors, as required
- Plan and implement quality and productivity improvement programs and cost and waste reduction; coordinate with the plant, R&D, Technical Operations, Engineering, Program Management, Global Supply Chain and other plant locations, as appropriate
- Establish formalized vendor improvement programs to improve the quality, cost, and service capability of vendors to the manufacturing facility
- Ensure safety measures are enforced to provide a safe and healthy workplace for all employees, vendors and visitors
- Contribute to the Environmental Management System (EMS) while aligning to the strategic direction and context of the business per ISO 14001
- Serve as a member of the site Senior Management Team (SMT)
- Conduct periodic visits to customers to ensure understanding all products and identify opportunities to enhance service levels
- Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics’ Quality
- Management System per ISO, FDA, and other regulatory agencies
- Support Environmental Management System (EMS) activities and compliance per ISO14001
- Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Who we are:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Sekisui Diagnostics offers a competitive compensation and benefits package
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.