We are now looking for a proactive and precise analytical development and quality control professional to join Faron as
CMC Specialist
The CMC Specialist will focus on analytical method lifecycle management, quality control, and stability activities. The ideal candidate will have experience in various analytical techniques and their lifecycle management (e.g. design, development, transfer, validation, change management), along with an understanding of related regulatory requirements. Knowledge and experience of biopharmaceuticals, stability study designing, data monitoring, and trending are desirable for success in this role. The goal of Faron CMC is to work consistently and with precision to advance our development programs.
Key responsibilities
- Supervision of outsourced analytical and quality control work and maintenance of up-to-date documentation and archives
- Development, validation and maintenance of analytical methods (incl. bioassays)
- Designing and coordinating stability programs
- Definition of specifications
- Product quality review and trending monitoring for release and stability results
- Shelf-life determination in cooperation with QA
- Supporting regulatory submission files
Ideal candidate:
- BSc or MSc in relevant scientific discipline with a minimum of 1-3 years of experience in analytical development and quality control in pharmaceutical industry; preferably with biopharmaceuticals
- In-depth knowledge and experience in various analytical techniques, especially bioassays, and their life cycle management, designing stability programs, data monitoring, trending and understanding of related regulatory requirements
- Experience in supervision and reporting of outsourced work
- Precise documenting skills
- Good communication skills and excellent written and verbal English skills
- Strong analytical and problem-solving skills
Finding the right person with a passionate professional attitude is important to us. The ability to learn on-the-go and to face new situations and challenges head-on are valued at Faron. The person we are looking for excels in project and time management with multiple priorities and works well independently, also under pressure. To find the right person for our work community, we are open to discussing the responsibilities of the role and the specifics of employment (e.g. location of the applicant) based on the candidate’s profile. The position will report to VP, CMC at Faron.
Why Faron?
At Faron, your work is a meaningful part in our mission to transform cancer care. Finding the right person with a passionate and professional attitude to enhance our talented team is a priority for us. We value the willingness to develop processes and face new situations and challenges directly. To support this, we offer good opportunities to develop your own professional skills through a range of training courses.
With us you can be part of dynamic working environment with a culture of collaboration and open communication. Our office is located in Turku, Finland, but we support a hybrid working model. We have versatile employee benefits.
Interested and confident you could be the person we are looking for? Please apply via apply button and attach your cover letter and CV in English. We hope to hear from you as soon as possible but no later than 16th March, 2025.
For any further questions about the position, please contact:
Marita Vainio, VP CMC at marita.vainio@faron.com or tel.+358 40 6885 547, during the following times: 5th March 14:00-15:00 or 10th March 13:00-14:00 (EET).
For further support with submitting your application, please contact careers@faron.com
APPLY HERE: https://faron.careers.hibob.com/jobs/5fd7ce06-e80f-4f1e-b1fe-90cc267efb0c/apply
