Description of position
We are looking for a highly motivated CMC Formulation / Analytical Scientist to lead biologics projects from research phase into early clinical development, with a specific focus on different types of antibodies as well as cell therapy.
Your main responsibility is to manage external drug substance and drug product development and external manufacturing sites. You have experience with early-stage development for therapeutic biologics. You will provide clear communication regarding CMC development pathway between internal experts, project management, external consultants and CDMO's. You collaborate across a range of different experience levels and will foster productive collaborations within Orion R&D and Orion R&D cross-functional partners such as External Supplies Operations and Quality Assurance.
In this position you will:
- Ensure drug substance and drug product development plans are aligned with the project timelines.
- Actively contribute to cross-functional Biologics CMC strategic discussions.
- Actively communicate and manage timely initiation of CMC activities at CDMO in collaboration with research teams, external CMC consultants and internal and external Orion partners
- Ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents.
- Encourage ideas and drive for continuous improvement and champion initiatives within Pharmaceutical Sciences, Orion R&D organization and across R&D partner functions.
- Understand and comply with Orion Pharma's safety, quality and regulatory policies and government regulations.
This permanent position is based in Turku or Espoo, Finland.
Description of unit
This position is situated in Biologics CMC unit, which belongs to Pharmaceutical Sciences department within Orion Pharma Research and Development. We operate in project CMC teams to develop new drug products for humans and animals in the exploratory phase of drug development process.
We offer
We offer a great team to join with skilled and highly motivated colleagues. Appreciation of colleagues and continuous development are part of our core values. We enable opportunities to utilize your skills and competencies widely as we continuously create something new.
Requirements
To succeed in this role, you possess the following:
- Ph.D. with 4+ years of industrial experience or MS Degree with at least 8+ years of related industrial experience preferred. Degree in Biologics Engineering, Biochemistry, Pharmaceutical Sciences or closely related field.
- Demonstrated technical experience in leading formulation and drug product process development of biologics, including process scale-up from laboratory to pilot scale.
- Lead cross-functional CMC developments and experience in managing global activities is highly desirable.
- Demonstrated capability to solve critical scientific and business problems.
- Excellent communication skills in English are required.
- Readiness to acquire and implement cGMP, cGLP and regulatory requirements for clinical development in EU and US.
In addition, you preferably have expertise in one or more of these areas:
- Biologics drug substance and drug product process development
- Biologics GMP manufacturing and IND/IMPD documentation
- Biologics analytical method development
Additional information
If you are interested in this opportunity, please apply by 31 May 2023. We may process applications already during the application period, so please submit your application as soon as possible.
If you have any questions, please contact Director of Pharmaceutical Sciences, Bert van Veen Tel. +358 50 966 4625 on Tuesday 23 May 10-11 a.m. EET (UTC+02) or Thursday 25 May 10-11 a.m. EET (UTC+02).
#LI-ORION
Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.
Orion Corporation operates in more than 30 countries, where we Orionees, 3300 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do.
Yhteystiedot: If you have any questions, please contact Director of Pharmaceutical Sciences, Bert van Veen Tel. +358 50 966 4625 on Tuesday 23 May 10-11 a.m. EET (UTC+02) or Thursday 25 May 10-11 a.m. EET (UTC+02).
Työpaikan osoite: 02200 ESPOO
Palkkaus: TES.
Työ alkaa: Työskentelyn aloitus sovitaan yhdessä
Työaika: Kokoaikatyö
Työn kesto: Toistaiseksi voimassa oleva
Hakuaika päättyy: 31.05.2023 20:59
Jätä hakemus: https://www.orion.fi/ura-orionilla/avoimet-tyopaikat?rmpage=job&rmjob=20...
Ilmoitus jätetty: 16.05.2023 00:00
Työmarkkinatorin ilmoitusnumero: bf6b138c-8dde-4f9e-a57c-cce26ae222ed
Lähde: Työmarkkinatorin asiakastietojärjestelmä
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Julkaistu 16.05.2023
