CMC - Lead to Intervacc

QRIOS AB; Stockholms kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Intervacc is looking for a CMC Lead to oversee the manufacturing and testing of our veterinary vaccines. This is a full-time position based in Stockholm, Sweden. The ideal candidate will have over 7 years of experience in biotech, particularly in vaccine development and regulatory compliance.

You will play a crucial role in ensuring project deliverables meet global standards, collaborating with various partners in the production process. Join a dedicated team at the forefront of veterinary vaccine innovation!

Qualifications

• More than 7-10 years of experience in biologics or biotechnology-derived products.
• Solid scientific background with significant experience in processing and analytical testing of biotechnology products.

Responsibilities

• Develop and deliver CMC-parts of development projects.
• Ensure compliance with global regulatory requirements.
• Monitor KPIs and ensure timely delivery of data.

Skills

Expert knowledge in analytical and/or process development for biologics

Significant experience in development, manufacturing and analytical testing of biologics

Knowledge of current regulatory CMC requirements

Excellent communication and documentation skills in English

Education

Formal academic degree (MSc., Ph.D) in pharmacy, biology or chemistry

Job description

At Intervacc, we are pioneering the next generation of veterinary vaccines through our proprietary technology platform. Rooted in research from the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), our mission is to reduce the impact of bacterial infections in animals through innovative, effective, and safe vaccines.

Our first proprietary product — a vaccine against strangles, a serious streptococcal infection in horses— is now available in several European markets. This is just the beginning. We are expanding our reach into new territories and broadening our product portfolio.

We have an exciting new opportunity for an experienced CMC Lead who will be responsible for the manufacturing and testing for the company’s marketed products, as well as the CMC-strategy for development of new vaccine products. The CMC Lead will have a central role in providing scientific guidance, support, and expertise for all CMC activities including commercial products and product under development. You will work with products in different markets to fulfill a key role within our dedicated, friendly and experienced team. If this sounds interesting to you – come join us!

Intervacc AB is headquartered in Stockholm Sweden and is listed on the Swedish Nasdaq First North Growth Market. The position is full-time, and we welcome your application today!

Key responsibilities

As a CMC Lead, you will provide CMC strategy and expertise for our development and marketed products to ensure the company’s products are developed, manufactured, tested and maintained in compliance with global regulatory expectations, requirements and guidance.

Duties and responsibilities include:

• Responsibility of delivering CMC-parts of development projects, launch projects as well as projects/products in commercial phase
• Developing CMC-strategies and ensuring oversight and planning of work performed at CROs/CMOs related to development, analytical testing and manufacturing of products
• Monitor KPIs and ensure timely delivery of data to support development, manufacturing and release
• Being responsible and promote using modern processing analytical principles such as Quality by Design, risk-based method development and data-driven decision making
• Working with other internal functions as well as external suppliers and partners to ensure CMC-deliverables and resolve arising issues
• Participating in budget planning and monitoring
• Ensure compliance with global regulatory requirements and support regulatory inspections and audits

Skills and Competencies

The suitable candidate has the following qualifications:

• Formal academic degree level (MSc., Ph.D) in a science-related subject e.g. pharmacy, biology or chemistry
• Significant experience (more than 7-10 years) in development, manufacturing and analytical testing of biologics or biotechnology-derived products e.g. vaccines from the pharmaceutical industry
• Significant knowledge of the drug development and manufacturing process for biologics (including upstream and downstream processes and analytical methods)
• Expert knowledge in analytical and/or process development for biologics
• Understanding of supply planning and supplier management
• Knowledge of current regulatory CMC requirements, and solid knowledge in understanding of regulations and guidance for the manufacturing of biotechnology products
• Excellent communication and documentation skills in English are required

The successful candidate for this position will be someone who:

• Has a solid scientific background with significant experience in processing and analytical testing of biotechnology products in combination with project management skills
• Is analytical, solution-oriented with a strong personal drive
• Is structured and organized
• Has a good eye for detail and a thorough approach to work
• Is a proactive, flexible, motivated and ambitious team player with ability to drive change

If you are ready to bring your expertise within the CMC area for biologics, we are ready to offer you an excellent career opportunity at an innovative company with an exciting journey ahead!

About Intervacc:

Intervacc is an innovative Swedish biotechnology company that develops and markets modern, effective, and safe vaccines against bacterial infections affecting animals. Over the past decade, advances in molecular biology techniques have significantly enhanced our ability to investigate the genomes of pathogenic bacteria. Building on our research foundations at the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), we have developed a technology platform for a new generation of vaccines. Our first proprietary vaccine, a vaccine against the streptococcal infection strangles, which affects horses—is now available in several European markets. The Intervacc share (STO: IVACC) is listed on the NASDAQ First North Growth Market and our headquarter is in Stockholm, Sweden. You can find more information about Intervacc at www.intervacc.se

For more information about this position, please contact:

Krishan Johansson Haque, PhD

Sr Recruitment Consultant, QRIOS Life Science & Engineering

T: [phone]

E: [e-mail]