Head of Viral Vector

4 weken geleden

Leiden, Nederland NecstGen Voltijd

**About the position**
As Head of Viral Vector you are responsible for the development and manufacturing of Cell
- and Gene therapy products. As such the Viral Vector department will have two modi operandi, a non-GMP for development and a GMP for production. The Head of Viral Vector will offer support to NecstGen business, independently liaising with clients, recruitment and mentoring of the team and advising management on projects and business strategy.

Operational management
- Ensure that the Viral Vector department operates efficiently;
- Ensure the Viral Vector team maintains a high level of data analysis and report preparation with critical evaluation of results;
- Participate in management reviews on the state of all activities and advocating continual improvement;
- Ensure the safety of assigned areas and work practices in accordance with company EHS and biosafety programs.

Training and supervision
- Provide leadership to the Viral Vector department by motivating, coaching, training, and guiding staff so they feel empowered and are enabled in reaching the Viral Vector department’s performance goals;
- Critically evaluate performance of personnel, co-developing training plans that support personal development and create a positive work environment.

GMP specific
- Ensure work practices and documentation in accordance with GMP guidelines;
- Support handling of deviation investigations, Change Controls, CAPA’s, Risk Assessments, protocols and reports;
- Support internal and external audits.

Other
- Ensure that a timely and effective communication and escalation process exists to raise (quality) issues to the appropriate levels of management;
- Lead work discussions and act as SME in complex internal and external meetings;
- Supports business development activities, communicate with clients and design of detailed project proposals.

**Key qual**ifications**
- PhD degree in biomedicine, biochemistry, biotechnology or similar;
- At least 10 years relevant work experience in the Viral Vector field;
- Experience with Viral Vector products based on Adeno-Associated Virus (AAV) or Lentivirus (LV);
- Experience in executing Viral Vector GMP and development projects;
- 5 years of progressive managerial experience and demonstrated experience leading experts from various fields relevant for the Viral Vector projects;
- Knowledge of GMP standards and ATMP regulations;
- Experienced in writing GMP documentation including SOPs, policies, Risk Assessments, CAPA’s and other manufacturing related documents;
- Hands on experience with the relevant platforms, processes and systems used;
- Familiar with the CMC (Chemistry, Manufacturing and Controls) requirements throughout the drug development life cycle;
- Strong verbal and written communication skills in English.

**Offer**

It is important that you are comfortable at work and enjoy coming to the office. We offer a modern and inspiring working environment with a collegial atmosphere, a flat organization with short lines and good employment conditions:

- A competitive salary
- 8% holiday allowance
- Permanent 13th month
- 25 holidays with a fulltime employment of 36 hours per week
- Commuting allowance (from 10 km) of € 0,23 per km and public transport is fully reimbursed
- A non-contributory pension scheme
- Several flexible employment conditions on top of the above conditions

**About NecstGen**

Together with our clients and partners we challenge today’s possibilities and enable the unthinkable.

NecstGen primarily works with early-stage research organisations, start-ups, and SMEs to develop efficient processes and perform GMP manufacturing for cell and gene therapies. We engage openly with organisations worldwide NecstGen is a subsidiary corporation of the Leiden University Medical Center. Our unique company formation enables us to be a mission based CDMO and Centre of Excellence. NecstGen’s 4,000+m2 facility comprises of 13 cleanrooms plus development and Quality Control laboratories for the generation of novel therapeutics. Our team of 40 consists of professionals from industry and academia with an entrepreneurial mindset and a drive to make a difference. We have a flat organisational structure with a participative management style.
Visit our LinkedIn company page to learn more about our team and the latest developments.

**We would love to hear from you**

Don’t hesitate to contact Warda Cardozo, Head of HR for more information.
- Unfortunately, sponsorships for Non-EU citizens are not available. _We do not wish to be approached as a potential customer or client._

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