Immedica has experienced remarkable growth in recent years and we are now strengthening our Manufacturing/CMC organization with an experienced analytical expert. The Manufacturing/CMC team is responsible for overseeing all aspects of the production of Immedicas’s products, all of which are manufactured externally. This includes defining CMC strategy, ensuring regulatory compliance, and coordinating activities with CLOs and CMOs.
As Senior Scientist Analytical Technology, you will play a key role in securing the quality, compliance, and lifecycle performance of analytical methods across Immedicas’s product portfolio. You will take the lead on analytical method transfers, validation activities, and continuous improvement initiatives, ensuring that our methods remain robust, efficient, and fit for purpose.
This is a new role created to gather all ASAT activities; hence it gives an exceptional opportunity for someone who wants to take lead and grow with the role. You will collaborate cross‑functionally and act as a central analytical resource supporting product quality, life cycle management projects such as manufacturing tech transfers, regulatory submissions, and ongoing development needs.
Since all laboratory work is conducted externally at CMOs and partner laboratories, success in this role requires strong collaboration skills, excellent communication, and the ability to build productive relationships with external partners.
Main responsibilities:
- Act as analytical subject matter expert (SME) for Immedica’s products
- Own and oversee analytical method performance, including trending of analytical release and stability data
- Identify and drive improvements in analytical methods and control strategies
- Coordinate stability studies, ensuring product stability and shelf life
- Manage reference standards
- Act as analytical SME in supporting investigations, changes, CAPAs and life cycle management activities
- Act as analytical SME in regulatory submissions, including ownership of specifications
- Lead analytical method transfers, method development activities and comparability studies
- Collaborate closely with internal product teams and external manufacturing & laboratory partners (CMO/CLO) to ensure quality and timelines
Why join?
Immedica Pharma offers an innovative, dynamic workplace with short decision paths and a high degree of ownership. Being a part of the Manufacturing/CMC team means you will work with engaged colleagues in a specialist role with high visibility and influence. You will have opportunities for professional development and continuous learning in a highly competent CMC environment.
Your profile
You are a self‑driven analytical expert with strong pharma experience and broad scientific knowledge. You take clear ownership of your responsibilities and communicate effectively with both internal and external stakeholders.
You act confidently as an SME, and are structured, quality‑focused, and improvement‑oriented. You thrive in fast-paced, hands-on environment and combine strong analytical expertise with a collaborative, business-oriented mindset.
Qualifications:
- MSc or PhD in analytical chemistry, biotechnology, or a related field
- 5-10 years of experience in pharmaceutical development or manufacturing of biologics or small molecules, including GMP
- Experience in analytical validation, tech transfer activities and stability study setup
- Experience in performing a broad range of analytical methods in the laboratory, e.g. HPLC, spectroscopy, ELISA, bioassay
- Good understanding of statistical methods for establishing specifications and evaluating analytical outcomes
- Ability to interpret and implement regulatory requirements (ICH/FDA/EMA etc.) in method transfer and comparability
- Experience of working with external labs/CMOs
- Fluency in Swedish and English, both written and spoken
- It is a strong advantage if you also bring:
Previous leadership experience, such as project management or team management - Previous experience of working with QC operations
Appealing?
Send in an application as soon as possible. In this recruitment, Immedica are collaborating with SallyQ. For questions, contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or [email protected].
About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases within metabolic, neurology, hematology & oncology, endocrinology and specialty care. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, external manufacturing, regulatory and medical affairs as well as market access. Serving patients in more than 50 countries, Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need.
Immedica was founded in 2018 by investment company Impilo and buy-in management and currently employs more than 180 people across Europe, the Middle East and the US. Of these, approximately 80 are based in the headquarters in Life City, Hagastaden, Stockholm.
At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues.
Open & Honest: We foster transparency, integrity, and trust through open communication.
Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape.
Empowered: We encourage collaboration and ownership, creating a supportive workplace where all team members’ contributions drive innovation and growth.
