Director Microbiology and Sterility Assurance .
Alvotech is an integrated biopharmaceutical company committed to developing and manufacturing high-quality biosimilar medicines for patients globally.
It is engaged in developing a pipeline of monoclonal antibodies that target a variety of therapeutic areas including inflammatory diseases, oncology, and ophthalmology. The company’s pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer.
The company's purpose is to improve the health and quality of life of patients around the world by improving access to proven treatments for various diseases.
They have a deep appreciation for the positive impact biologic medicines have had on health care. From insulin to vaccines to monoclonal antibody cancer therapies, biologic medicines are revolutionizing the way they treat diseases and improve patient lives.
It is their aim to broaden the availability of these important biologic medicines to patients around the world by developing and manufacturing high-quality, cost-competitive biosimilars.
- Provide oversight and quality standards of sterility assurance of the Alvotech facilities (existing and future)
- Provide oversight and sterility assurance expertise to operations to ensure aseptic processing meets international aseptic processing standards
- Oversee the documentation and management of the microbial control strategy for DS and DP production processes from incoming goods to final product
- Contribute to the smooth technical transfer of new processes/product into QC Microbiology
- Ensure usage of qualified utilities/environment for operation to achieve the regulatory requirements for drug substance/product manufacture
- Ensuring issues within the laboratory are resolved with minimum disruption
- Responsible for driving and leading innovation, providing expertise and strategic leadership across the team
- Lead or delegate leadership of improvement projects within the sterility assurance and QC microbiology
- Provide feedback to CLT/ peers / relevant departments on program status, highlighting and mitigating any constraints
- Develop all necessary tools and processes and select the right resources to establish an efficient and transparent working environment within Micro and SA
- Support external contacts including Regulatory Authorities, professional, scientific and regulatory groups, trade associations and consultants to ensure regulatory compliance in support of the Alvotech portfolio
- Provide microbial and sterility expertise for GMP documents including but not limited to SOPs, batch records, APS protocols, validations, and specifications
- Align with all departments to ensure cross functional involvement & feedback is present across projects, ensuring risks are evaluated and minimized by using continuous problem-solving techniques
- Be accountable for ensuring the QC Microbiology laboratory areas and equipment are maintained in a state of inspection readiness by proactive interaction with other departments (e.g., Engineering, Facilities & EHS)
- Anticipate internal and external drivers of changes to strategy, and respond by making rapid, welljudged adjustments to the program plan
- Drive, encourage, coach & manage the support of employees to achieve business goals. Actively develop talent within the teams
- Responsible for keeping the team engaged, motivated, enabled and empowered to achieve their goals and objectives
- Create reporting dashboard of relevant KPIs for QC leadership
- Provide microbiology and sterility assurance expertise during the investigations of deviations or
- Be an SME author of CAPAs and change controls relating to sterility assurance and QC microbiology processes as required in span of expertise
- Provides microbial and aseptic expertise to support EMI and complaints related to aseptic and sterile processing
- Support any other quality related duties as required to support department and company
- Accountable for the following functions:
- o Sterility Assurance
- o Microbiology Operations
Profiel van de kandidaat.
- An employee shall follow the job description that pertains to their position. In addition, an employee shall follow the SOPs that pertains to his/her position.
- An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to them and do whatever is necessary to solve it.
- It is important that an employee has the company values at heart.
If you are interested in this position and would like to know more about it, please contact:
Marie Couvelaere, Recruitment Specialist
T: +33 (0) 7 87 65 93 61
Jurgen Rillaerts, Recruitment Consultant
T: +33 (0) 7 88920152