Head of Aseptic Filling
The Head of Aseptic Filling will lead the Filling Department in the start-up, qualification and validation of the New Albumin Filling Plant. This will include the completion of Medias, Conformance lots to meet NDA Submission filing timelines, as well as audit readiness and commercialization of the new facility.
Will also be responsible for directing the output of the Filling Team, ensuring best practices are applied to and adhered to in cleaning and maintaining the workplace, assembling, disassembling and operating production equipment (Final Filling Assemblies, Filling Machine, Over-wrappers, Pasteurisers, Autoclaves, In process equipment etc) as per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.
- Leads the planning and organization of the specific job assignments in accordance with the production schedule, cGMP, and safety regulations.
- Manage employee performance and development, attendance, and coach/counsel employees.
- Develop and delegate to senior staff (i.e., coordinator and Sr. Techs) activities to strengthen performance development.
- Write and conduct annual and mid-year performance reviews for employees.
- Maintain production schedules, timecards, documentation requirements, etc.
- Ensure that the proper training of all personnel is accomplished timely, effectively, and consistently.
- Demonstrates the ability to compromise and reach consensus in areas of responsibility.
- Serves as an expert for process/product troubleshooting in order to correct or maintain desirable process parameters.
- Research and addresses process deviations, documentation errors, ITS', etc.
- Provide insight in resource/headcount planning and raw materials and budgeting activities.
- Provide input or may sometimes lead subgroups on various project initiatives (i.e. new technology, SAP, etc.).
- Ensures project integrity through enforcing compliance with all cGMP's and employee safety through enforcement of site policies and rules.
- Promote and communicate to employees company/department/site goals, expectations, policies, and procedures.
- Promote among employees established company beliefs and values with integrity.
- A working knowledge of the regulations to produce sterile products for distribution to global markets.
- Ability to facilitate regulatory body audits.
- Presentation skills
- Ability to understand the key elements of complex problems and focus attention on these elements,
- 5+ years of experience in pharmaceutical/bioscience or medical device manufacturing
- 5 years of management experience managing a team of 10 or more
- Report writing
- Teamwork skills
- Microsoft Office Proficiency
- Bachelor's degree in a related field
- Qualification in Lean or Six Sigma
- Meeting facilitation skills
- Strong technical ability
- Ability to travel or relocate for short periods of time.
- Project Management
- Strong Leadership
- Strong communication skills
- Operations Focused
- Problem Solving