Gaston Geenslaan 1 Leuven Belgium
Who are we?
Ready to change the world one gene at a time?
Handl Therapeutics is a gene therapy company located in Leuven, Belgium.
Our goal is to address significant unmet medical needs by deploying the power of disease modifying in vivo gene therapy to treat complex neurodegenerative diseases.
We follow a highly integrative approach collaborating with world leading service providers in the field and are proud to work together with an international network of prominent academic partners.
As our new analytics lead, you will lead the activities related to the development, validation and implementation of analytic methods and quality controls for the testing, lot release and characterization of Handl Therapeutics’ gene therapy product programs. More specifically, you will work with the Company’s designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs), you will also lead an in-house team of experts.
Define the analytical strategy and lead the development, qualification, validation and implementation of analytical methods for:
In-process QC and characterization testing
Drug Substance characterization, QC release and stability testing
Drug Product characterization, QC release and stability testing
Liaise with Handl’s academic and industrial partners to:
Help define the long-term analytical strategy for Handl’s products from preclinical, Phase I/II and up to Phase III pivotal trials, including defining comparability study strategies.
Establish systems for the implementation and transfer of analytical methods to in-house QC or to CMOs and CTOs
Develop product characterization databases to support regulatory filings
Desired skills and experience
A Ph.D. in Biological Sciences, Bioengineering, Chemistry or an associated discipline
Minimum of 5 years of experience in the biotechnology or pharma industry with a primary focus on analytical methods and analytical QC for biologic products
In-depth experience of analytical methods and regulatory/pharmacopeia requirements for biologic product testing, characterization, and method validation
In-depth knowledge and proven application of FDA, EMA, GMP and ICH regulatory requirements
Independent, flexible, high energy leader who can operate in a fast-paced, entrepreneurial industrial environment
Experience of QC release testing and characterization of viral vector-based products is a must. In addition, knowledge of phase-appropriate adeno-associated virus (AAV) vectors characterization and release testing requirements is a plus.
Experience with the development, validation, and application of analytical techniques in a QC environment, including FACS, DLS or other molecular sizing methods, HPLC, ELISA, Capillary Electrophoresis, DNA sequencing, PCR and cell-based assays
Experience of managing CMO/CTO relationships and projects
Sound understanding and demonstrated application of statistical methods/tools
In-depth knowledge of US and European Pharmacopeia methods and requirements
In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
Excellent organizational and interpersonal skills
Excellent written and oral communication skills
Manage the Analytical Method Development and QC functions associated with the development, GMP production and testing of the Company’s products
Oversee activities at CMOs and CTOs for the development, qualification and implementation of analytical methods, including the review and approval of protocols, test records/forms, final reports, Standard Operating Procedures (SOPs) and Certificates of Analysis (CoAs)
Establish and oversee/execute stability programs for drug substances and drug products
Drafting and review of SOPs, records/forms, CoAs and protocols for in-house QC testing and overall Company QC operations
Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
Assist in the preparation of CMC regulatory submissions
Other activities as may be assigned
What can Handl Therapeutics offer you?
You will part of a team that will change the treatment paradigms of large CNS diseases
You will work in a challenging and innovative environment where ownership and team playing are highly important for reaching success.
Competitive remuneration package.