We at Xenikos are looking for driven, energetic and enthusiastic new colleagues for our company of 9 employees:
Senior Scientist Drug Product Development
0.8-1.0 FTEBiopharma, Innovative, Immunology, Parenteral drug manufacturing, Aseptic filling, Lyophilization, Phase III clinical, Virtual Operation
Nijmegen, January 28, 2022 • Application deadline February 21, 2022
Xenikos B.V. is looking for a seasoned Drug Product Development Scientist to strengthen its team as the company moves through Phase 3 clinical testing of its flagship product T-Guard®. The new employee will report to the COO and join us in the preparations to file for Marketing Authorization in the US and EU within the coming years, and beyond into commercialization and the expansion of our product portfolio.
As Drug Product Development Scientist at Xenikos, you will further optimize and define the DP manufacturing process, develop the sourcing- and validation strategy and own the content of the P-part of the CTD registration dossier.
The company operates in a semi-virtual mode, not running own laboratories or manufacturing sites, so your work will also include the selection, qualification and oversight of third-party service providers (CDMOs).
You will author and own the Validation Master Plan for DP and be leading in the presentation of the strategic choices in scientific advice procedures and other regulatory interactions. The further development, optimization and process characterization will be under your supervision. Furthermore, you will author and review other quality system and regulatory submission documents; protocols and reports, specifications, non-conformances, out-of-specifications and root cause investigations, change requests, manufacturing records and complaints. We expect the new employee to contribute in a broad sense to the further development of the Quality System as required to allow Xenikos to become a commercial manufacturer.
You will be expected to manage your own work schedule effectively and efficiently and to keep up to date with the latest developments in pharmaceutical quality / GMP regulations, directives, and guidelines related to drug product manufacturing.
Founded in 2009, Xenikos is a Biotech company operating from Nijmegen, the Netherlands, developing innovative new immunotherapies based on conjugated antibodies. Our flagship product T-Guard® resets the immune system in patients who have a severe immune disease or developed post-transplantation rejection. This therapeutic approach is now entering Phase 3 testing for treatment of steroid-resistant acute graft-versus-host disease (SR-aGVHD); a life-threatening condition common in patients following hematopoietic stem cell transplantation.
At Xenikos you will work closely together with the other members of the operational CMC team. This group has a technical and scientific focus and is currently 6 employees strong, expecting to expand to approximately 10 employees during the year. Other important ties are with the Manager QA / Qualified Person, the Clinical Development team and the Manager CMC Regulatory Affairs (RA).
We strive to build an inclusive and safe working environment, with open lines of communication and we embrace diversity. You will be working in a close-knit team of professionals (MSc/PhD level) in an inspiring and dynamic working environment where you will be helping to save patient’s lives, and your input is valued. If you dream of a job where you are at the forefront of today’s science and where your contribution can really make a difference, then Xenikos is for you.
What we expect from you
Education & Experience:
- A University degree (or an equivalent level of proficiency gained through experience) in biotechnology, pharmacy, biology, (bio)chemistry, bioprocessing, or a related discipline;
- At least 5 years of relevant working experience, preferably within a DP manufacturing department in the biopharmaceutical industry;
- Experience in mid-to late-stage process development, process characterization, process validation and -commercialization;
- Proven affinity with, and broad understanding of biopharmaceutical manufacturing;
- Understanding of GMP requirements and, in particular, process validation aspects;
- Thorough understanding of legislation/regulations, directives and guidelines applicable to biopharmaceutical manufacturing;
- Thorough understanding of relevant regulatory processes.
- A pioneering mindset;
- Ability to deal with complexity and conflicting interests and priorities;
- Builder of relationships within an international collaboration network;
- Ability to change perspective between the bigger picture and the technical details;
- Language skills: English and preferably Dutch;
- Team player who can think on their feet, is capable of working independently and is assertive, well-organized and helpful.
- An employment contract for 0,8 - 1,0 FTE;
- Office in Nijmegen, flexibility in working remotely;
- A competitive salary, based on experience, plus an 8% holiday allowance;
- 25 vacation days (based on 1.0 FTE);
- Duration of the contract is negotiable;
- An inclusive, inspiring and innovative working environment, with room for personal growth;
- The opportunity to help bring a potentially life-saving treatment to patients that currently have no alternative treatment option.
The starting date of the employment contract is open to discussion, but preferably as soon as possible.
We are an equal opportunity employer, and as such encourage applications from minorities, and from any gender or race.
For more information about this vacancy, please contact:
Maarten Frijlink, Chief Operating Officer
Telephone: +31 6 19 45 37 57
See www.xenikos.com for more information about Xenikos and T-Guard®.
Please send your application to email@example.com. Make sure to include a letter of motivation, as well as your resumé.
Incomplete applications will not be considered.
Please send in your application by February 21, 2022.