Senior Manager Jobs at a Leading Biotech Company
Senior Manager Jobs at Leading Biotech Company Amgen Dun Laoghaire in Dublin, Ireland. Interested Candidates can check out the details below and Apply.
Job Position: Sr. Manager Validation
Job Location: Dublin, County Dublin, Ireland
Job Company: Amgen Dun Laoghaire
Amgen is a leading biotechnology company, dedicated to improving the lives of patients worldwide. With a focus on research, development, and manufacturing of innovative therapies, Amgen is at the forefront of the industry. We are currently seeking a senior manager Validation to join our team in Dublin, County Dublin, Ireland.
Overview:
This job specification outlines the general responsibilities associated with the role of Sr. Manager Validation on the Amgen Manufacturing Site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are directly associated with their role.
Key Responsibilities:
- Lead in the development of Validation’s vision, mission, strategies, goals, and objectives to ensure the area achieves the company goals.
- Maintain, implement, and continuously develop a Validation strategy while ensuring alignment between business strategy and the requirements of critical stakeholders such as corporate, regulatory & legislative requirements.
- Responsible for providing Validation expertise in the area of equipment sterility, aseptic processing simulation (or media fill) and temperature mapping.
- Manage the qualification/validation of production equipment, utilities and systems directly associated with sterility of equipment and processes.
- Provide support for Tech Transfers (NPIs and LCMs) and regulatory submissions.
- Oversee the preparation, execution, documentation and reporting of validation studies for your area of responsibility in line with GMP’s and other regulatory requirements and standards.
- Responsible for the development, revision, review, and approval of Standard Operating Procedures within your area of responsibility.
- Strong people and project management skills with proven ability to define and execute the validation elements of a projects from design to routine facility operation.
- Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization.
- Assure the appropriate level of training is undertaken for all levels of the validation organization which may involve developing training material.
- Responsible for recruiting talented staff into the facility and setting standards for their performance.
- To maintain and foster the broader objectives of the company in the Validation department by promoting the spirit of Leadership Behaviours and company Values and emphasizing the need for teamwork with all departments.
- Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
- Provide cost improvement programs, identify and adapt new technology.
- Be part of a learning and development program which will include goal setting, annual performance reviews and individual development plans.
- Be a champion for safe working practices and safety initiatives within their functional area.
Basic Qualifications:
- Typically 5+ years of experience in a management position. With typically 4+ years experience supervising validation / technical staff.
- Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering.
Preferred Qualifications:
- Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation.
- Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan.
- Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage.