LINK Medical is searching for a highly motivated Principal Consultant Pharmaceutical Development & CMC in Stockholm or Uppsala.

In this role, you will work in close collaboration with our local and international clients, being responsible for leading and managing Chemistry, Manufacturing, and Controls (CMC) activities throughout the drug development lifecycle—ensuring product quality, regulatory compliance, and efficient project delivery.

Responsibilities

• Develop CMC strategies, such as QTPP, in alignment with the client’s project strategies.

• Lead and execute CMC projects across drug substance and drug product development.

• Drive and coordinate cross-functional alignment with QA, RA, Supply Chain, CDMO and CMOs to ensure timely and compliant CMC delivery.

• Manage CMC project plans, budgets, and risk registers.

• Oversee manufacturing, testing, tech transfer, and documentation of drug substance and drug product (non-GMP and GMP).

• Author, review, and maintain CMC documentation for regulatory submissions, such as IMPD, IND, MAA and NDA.

• Ensure compliance with cGMP, ICH, and regulatory standards.

• Participate in planning and performance of technical, quality and sponsor audits, and manage related deviations, CAPA, and change controls.
  

Desired qualifications

• BSc, MSc, or PhD in a relevant scientific field.

• 5–10+ years of industry experience in CMC, process development, or manufacturing.

• Experience across several drug classes such as small molecules, biologics, peptides, oligonucleotides, ATMPs, and/or vaccines.

• Advantageous to have experience from either drug substance management and/or clinical supply

• Strong understanding of QbD, GMP/ICH guidelines, and regulatory expectations.

• Proven project management experience with internal and external partners.

• Excellent communication and technical writing skills.

• Experience with global regulatory submissions such as IND, IMPD, etc.

• Proficiency in Microsoft Office applications.

• Fluent in Swedish and English.
  

Personal Characteristics

• Proactive, collaborative, and adaptable mindset.

• Strong relationship-building and coordination skills.

• Focusses on client needs, with strong communication and presentation skills.

• Well-organized, able to work both independently and within teams.

• Commercial awareness and negotiation ability.
  

LINK Medical offers

We offer an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees in an international environment and values as honest and open communication are essential. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation, benefit scheme and great development opportunities for all employees.

Contact Information

If you would like to know more or if you have any questions about the position, please contact:

Ulrika Andersson, Senior Director Drug Development,

+46 76 492 4518, Ulrika.andersson@linkmedical.eu

All applications are treated confidentially and will be evaluated when received, so please apply as soon as possible. Please submit your application in English.

Last day for application: 15 April, 2026