Do you want to help shape the future of biological medicines while also contributing to creating new business? At RISE Life Science, we are now looking for a senior and experienced CMC expert (Chemistry, Manufacturing and Controls) for biological medicines.
The role suits you who want to combine deep technical and regulatory expertise with strategic collaboration and business acumen.
About us
RISE is a driving force in the sustainable transformation that industry, society and the world need. We develop and test solutions that make a difference today – and build knowledge and technologies that could be decisive tomorrow. Within RISE division Life Science, we bring together different perspectives and cutting-edge expertise to, together with industry, academia and authorities, accelerate the development of new medicines and advanced therapies.
With us, you will work in a qualified and technically strong environment, where senior expertise is highly valued and where you have real opportunities to influence assignments, direction and collaborations.
What we offer:
A dynamic work environment where research meets innovation.
The opportunity to influence and develop future solutions within Life Science.
A network of engaged colleagues and collaboration partners.
Flexible working arrangements and good development opportunities.
About the role
As a senior CMC expert, you play a central role in assignments spanning from cell culture to formulation, linked to the development, CMC strategy and quality assurance of biological medicines, including biosimilars. You operate at the intersection of technology, regulation and business, and are a key person in further developing RISE's capacity within Biologics – such as protein medicines and advanced therapies.
The role involves close collaboration with industry clients, academia and authorities, where you contribute senior expertise to translate complex needs into structured and feasible projects. The work is cross-functional and you will collaborate with colleagues within Life Science, Biorefinery and Energy, as well as other departments within RISE. You will create collaboration and connections between the various biological business branches primarily in Stockholm, Örnsköldsvik, Södertälje and Gothenburg/Borås.
The location for this role is Stockholm/Södertälje.
Main responsibilities:
Lead and contribute to projects in the development and quality assurance of biological medicines.
Work cross-functionally with colleagues within Life Science and other departments at RISE.
Identify and develop new business opportunities in collaboration with industry, academia and authorities.
Be a key person in building and further developing our capacity within Biologics, including cell and gene therapy, protein medicines and other advanced therapies.
Who you are
We are looking for you who are senior within biological medicines and want to combine deep CMC expertise with business-driven collaboration.
Doctoral degree (PhD) in a relevant field (e.g. biotechnology, pharmacy, biochemistry, chemistry or equivalent).
At least 10 years of experience from the pharmaceutical industry or equivalent academic research within biological medicines.
Deep expertise in CMC for biological medicines, preferably with experience from regulatory processes.
Experience in project management and collaboration with external partners.
Strong business acumen and ability to identify customer needs and translate them into concrete projects.
Very good understanding of CMC for biological medicines, including development, manufacturing and control strategies.
Good communication skills in both Swedish and English, written and spoken.
Meriting:
Experience of regulatory CMC interactions and dossier work (e.g. IMPD/CTD, variations, authority dialogue).
Experience of tech transfer, process scale-up, CDMO collaborations and/or establishment of manufacturing chains for biologics.
Are we right for each other?
At RISE, we like different and we are convinced that diversity contributes to an innovative environment where we together challenge boundaries and develop new knowledge for the future. With us, passionate problem solvers meet to solve some of the world's most important, and perhaps fun, problems. We can not promise you an easy job, but what we can promise you is a bunch of committed colleagues and some really exciting societal and industrial challenges to tackle. You will work in a dynamic environment that gives you development opportunities both professionally and personally. With us, you get the opportunity to make a real difference. Welcome to the research institute and innovation partner for the entire of Swedish.
Welcome with Your Application!
For more information, please contact the recruiting manager Esmail Yousefi, Head of unit Pharmaceutical Development, at [email protected]. The last application date is June 20th. Selection and interviews will be conducted continuously during and after the application period. Apply without cover letter.
Our union representatives are Ingemar Petermann, SACO, +46 10 228 41 22 and Linda Ikatti, Unionen, +46 10 516 51 61.
