Associate Director, Quality Control

** Job Description*
* ** Organizational context:*
* Within our company's Manufacturing Division, the Micro Analytical Sciences (MAS) section within the Global Quality Large Molecule Analytical Sciences (GQLMAS) organization, located in Wilmington, Dunboyne and Oss, scientifically support the microbiological laboratories in the commercial production sites for vaccines, biologics and small molecules. The MAS team plays a crucial role in supporting the transfer, troubleshooting and life cycle management of the microbiological test methods (including equipment) for all modalities.

This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Furthermore, MAS is seen as the owner for global microbiological methods and equipment packages to ensure a structured transfer of the methods.

*
* Job purpose:

*
* The individual will support US-based sites and play an important role in developing the Microbial laboratory at Wilmington Biotech Campus. The individual is responsible for several microbiological/virological methods, and will serve as a Subject Matter Expert for some. Their role includes assisting with method transfers for commercial products, regulatory interaction such as response to questions, and providing training to the network.

Their responsibilities include ensuring that methods are properly introduced and qualified by the receiving unit during the transfer process in accordance with established guidelines. They are also tasked with overseeing methods for complex products on a global scale and coordinating the involvement of relevant Subject Matter Experts.

The Associate Director supports microbiological studies essential to production sites by providing both practical and scientific expertise as needed. In this capacity, the Subject Matter Expert contributes technical and scientific insights to these processes and is required to travel for at least 20% of their time.

In addition to their responsibilities, the Associate Director will serve as the point of contact for commercial production sites on microbiological methods and will act as a global method or equipment package owner.

The Associate Director will support the Micro Analytical Sciences leads by coaching Senior Specialists, Specialists and associate specialists in the team and taking up a senior role in the team.

** Position in the organization:*
* Manager (reporting):
Reports to Lead Micro Analytical Sciences

Staff: not applicable

** Key activities*
* Scientific and Technical leadership

+ Deep technical expertise as a Microbiological / Virological SME, with deep scientific understanding of the microbial /virological techniques used in pharmaceutical industry.

+ Responsible for best scientific practices within the lab space and supports from an SME perspective, troubleshooting, network and life cycle management activities for methods in their expertise at the network sites.

+ Leads the implementation of microbiological / virological methods (compendial/alternative microbiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally).

+ Provides scientific and practical support to analytical investigation during validation, method suitability and routine use.

+ Accountable for scientific and practical support for microbiological tests on an as-needed basis for methods and studies in their expertise on an as-needed basis for the transfer of Biologicals, Vaccines and/or Small Molecules.

+ Leads the evaluation, method development, method validation of alternative microbiological technology (Rapid Microbiology Methods).

+ Responsible for authoring primary and secondary source documents used for regulatory filings.

+ Recruitment and supervision of MSc students

+ Project Member and/or lead

+ Recruitment and supervision of MSc students

+ Acts analytical lead in the implementation / deployment of alternative microbiological technology (Rapid Microbiology Methods)

+ Root Cause Analysis lead for significant investigations.

+ Participates as Analytical lead in multidisciplinary teams solving technical problems at global or multisite level.

+ Participates in global change control processes as an SME or Impact accessor.

+ Serves as the point of contact for microbiological / virological methods for the commercial production sites based in the US.

+ Analytical lead for global methods or equipment package in their expertise, driving the standardization of microbiological / virological methods in the network together with relevant SME's.

Compliance

+ Takes GMP requirements into account when setting up experiments and protocols.

+ Ensures compliance of protocols and reports.

+ Contributes to the regulatory (CMC) teams to ensure that the required documentation is in place for product submission (Licensing application) to authorities (e.g. FDA, EMA, China) including response to questions from agency in a timely manner.

+ Participates as SME in or leads multidisciplinary teams supporting…