PhD Position in (Bio)Chemistry or Pharmacy within MSCA Doctoral Network MMM, Gera and Ilmenau, Germany

Biano GMP, Germany

Updated: 2 months ago

Location: Gera, TH RINGEN

Job Type: FullTime

Deadline: 29 Feb 2024

19 Feb 2024
Job Information

Organisation/Company: Biano GMP
Research Field: Chemistry » Biochemistry
Chemistry » Other
Pharmacological sciences » Pharmacy
Researcher Profile: First Stage Researcher (R1)
Country: Germany
Application Deadline: 29 Feb 2024 - 23:59 (Europe/Berlin)
Type of Contract: Temporary
Job Status: Full-time
Hours Per Week: 38,5
Offer Starting Date: 1 Mar 2024
Is the job funded through the EU Research Framework Programme?: HE / MSCA
Marie Curie Grant Agreement Number: 101120256
Is the Job related to staff position within a Research Infrastructure?: Yes

Offer Description

PhD Position in (Bio)Chemistry or Pharmacy within MSCA Doctoral Network MMM, Gera and Ilmenau, Germany

Modern medicine seeks to personalize diagnosis and treatment to the needs of individual patients. This need is heightened in particular for those individual patients where no treatments are available – and where current standard treatment development paradigms exclude to generate such. The ultimate goal of Medicine made to Measure (MMM) is to go even beyond the latest genetic medicine approaches, implementing a novel paradigm of treatment development: the field of single patient tailored antisense oligonucleotide (ASO) treatments for patients with nano-rare disease mutations. Specifically, MMM will develop core modules of a novel “out-of-the-box”, but still EMA-advised treatment development path for these patients - from omics-based theranostics, via preclinical target validation to innovative trial methodology and a pioneering ethical framework for individualised genetic therapies. MMM provides a unique opportunity for doctoral candidates to be involved in building - and to receive training - in all core modules needed for tailored ASO treatment in Europe. This new scientific field requires a new generation of open-minded, technology-fluent and applications-oriented experts.

MMM will help educate future drug development and translational experts in adopting and disseminating such a cross-specialty approach. Our idea for this innovative training network is built on our personal experience and understanding of the importance of single patient tailored genetic treatments in the years to come. We propose a consortium of world-leading experts and partners that present with extended experience and relevant know-how in molecular biology, neurology, translational medicine, biochemistry, bioinformatics, philosophy, mathematics, regulatory science and engineering.

We offer an attractive education and training programme that extends from engagements in high-level research projects, through tailored and network-wide training modules to providing competencies and skill sets that help young researchers go beyond the specific MMM research paradigm. Thus, MMM provides an exceptional platform to young, ambitious and talented researchers who like to engage in supporting the concept of single patient tailored treatments.

PhD PROJECT: GMP workflow optimisation for N-of-1 treatment

Currently, production of ASOs at clinical grade is optimized for larger patient cohorts and, hence, multi-kilogram scales. The distribution to literally hundreds of clinics, multiple dosing regimen and the requirement for long term clinical trials induce the need for complex stability studies already for development and manufacturing of ASOs for phase 1 clinical trials. This means that the major share of the oligonucleotide is produced for analytical and test purposes. Large scale GMP synthesis for the mentioned clinical trials require a high level of upscaling and optimizing activities, which results in long production timelines and high costs.
The MMM concept is designed to avoid this overhead burden. Just a small amount of the ASO product is required for the individual, single patient. As the target diseases progress continuously and irreversibly, there is an ultimate need for short production times and release periods. Furthermore, manufacturing of medicines made to measure must be cost-effective to be affordable for a sustainable European health care system.
Approach: Optimizing manufacturing and establishing standard pre-validated analytical methods for small scale ASO candidates.

To establish a transferrable small scale GMP manufacturing process for individual ASO candidates, two major aims have to be addressed:
1) analytical methods have to be optimized for all CHMP validation requirements. It will be investigated to which extent they could be employed as standard methods for structurally similar ASO candidates
2) downstream processes will be optimized accordingly to apply them almost unmodified to other ASO candidates

The resulting generic manufacturing and analytical methods will massively reduce production cost and times and still provide safety levels matching those for standard GMP process development. The feasibility of transferring the generic GMP process with optimized and pre-validated standard methods will be tested and verified with 5 ASO candidates.
Finally, a layout of a regulatory framework for defining GMP of N-of-1/individual therapies will be based on existing FDA proposals, on consultations with EMA and competent national authorities for single patient application where we strive to provide as many release analytic parameters as possible as generic ones without compromising patient safety.

The recent PhD position will focus on optimizing the production of the MMM ASOs and validation of the synthesis and downstream process as a GMP workflow.

Therefore we are looking for Students having a strong chemical background and interest in oligonucleotide chemistry as well as regulatory aspects. Results of the work are aimed to be published in high-ranked scientific journals and to be presented at MMM and international conferences.

Requirements

Research Field: Chemistry » Biochemistry
Education Level: Master Degree or equivalent

Skills/Qualifications

SPECIAL REQUIREMENTS: We are looking for students having a Master degree in chemistry, biochemistry, pharmacy or related area with strong chemical synthesis background and interest in oligonucleotide chemistry as well as regulatory aspects.

Languages: ENGLISH
Level: Excellent

Research Field: Chemistry » BiochemistryPharmacological sciences » PharmacyChemistry » Other

Additional Information
Benefits

Gross salary (without employer’s social contributions) 3942€ per month, plus additional family allowance, if applicable.

Eligibility criteria

Researchers must be doctoral candidates (i.e. not already in possession of a doctoral degree at the date of the recruitment). Researchers who have successfully defended their doctoral thesis but who have not yet formally been awarded the doctoral degree will not be considered eligible.

Researchers must not have resided or carried out their main activity (work, studies, etc.) in the country of the recruiting beneficiary for more than 12 months in the 36 months immediately before their date of recruitment. Compulsory national service, short stays such as holidays, and time spent as part of a procedure for obtaining refugee status under the Geneva Convention are not taken into account.

Selection process
Selection process

Full applications should include

A motivation letter
A Europass CV (https://europa.eu/europass/en )
Copies of your relevant certificates
Names and contact details for at least 2 potential referees

Applications should be submitted to: [email protected] or [email protected] . In case of any procedural questions, please contact [email protected]

Website for additional job details: https://medicine-made-to-measure.eu/
https://bianoscience.com/

Work Location(s)

Number of offers available: 1
Company/Institute: BianoGMP
Country: Germany
City: Gera
Geofield

Where to apply

E-mail: [email protected]

Contact

City: Gera
Website: https://medicine-made-to-measure.eu/
https://bianoscience.com/
E-Mail: [email protected]
[email protected]

STATUS: EXPIRED

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