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Senior CMC Expert for Biological Medicines
RISE Research Institutes of Sweden ABStockholms län, Stockholm
Previous experience is desired
16 days left
to apply for the job
Do you want to shape the future of biological medicines while contributing to creating new business opportunities? At RISE Life Science, we are now looking for a senior and experienced CMC expert (Chemistry, Manufacturing and Controls) for biological medicines.
This role is perfect for you if you wish to combine deep technical and regulatory expertise with strategic collaboration and business acumen.
About Us
RISE is a driving force in the sustainable transition that business, society, and the world need. We develop and test solutions that make a difference today – and build knowledge and technologies that may be crucial tomorrow. Within RISE's Life Science division, we bring together diverse perspectives and top-tier expertise to accelerate the development of new medicines and advanced therapies in collaboration with industry, academia, and authorities.
Here, 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 partners.
Flexible working arrangements and good development opportunities.
About the Role
As a senior CMC expert, you play a central role in assignments ranging 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, regulations, 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 industrial customers, 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 foster collaboration and connections between the various biological business areas, primarily in Stockholm, Örnsköldsvik, Södertälje, and Gothenburg/Borås.
The location for this role is Stockholm/Södertälje.
Key Responsibilities
Lead and contribute to projects within 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.
Serve as 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 a senior professional within biological medicines who wants to combine deep CMC competence with business-driven collaboration.
Requirements:
A 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 competence in CMC for biological medicines, preferably with experience from regulatory processes.
Experience in project management and collaboration with external partners.
Strong business acumen and the 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 verbal.
Merits:
Experience with regulatory CMC interactions and dossier work (e.g., IMPD/CTD, variations, authority dialogue).
Experience with tech transfer, process scale-up, CDMO collaborations, and/or establishment of manufacturing chains for biologics.
Are We the Right Fit?
At RISE, we value diversity, and we are convinced that diversity contributes to an innovative environment where we can challenge boundaries together and develop new knowledge and skills for the future. We cannot promise you an easy job, but what we can promise is an exciting journey where, together with engaged and talented colleagues, we will contribute to a sustainable future and stay at the forefront of global competition. Do you want to be part of it?
Apply Now!
Does this sound exciting and do you want to know more? Feel free to contact Esmail Yousefi, Unit Manager for Medicine Development, at [email protected]. The application deadline is June 20th. Selection and interviews take place continuously during and after the application period. Please apply without a cover letter.
Our union representatives are Ingemar Petermann, SACO (010 228 41 22) and Linda Ikatti, Unionen (010-516 51 61).
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