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SwedenDirector Manufacturing at Scandinavian Biopharma in Stockholm

Director Manufacturing at Scandinavian Biopharma in Stockholm

ARBETSBESKRIVNING
Civil Engineer, Biotechnology Short Facts About The Job

Duration:
Until further notice

Form of
employment: Permanent or fixed-term employment

Qualifications

MSc, Biotechnology – experience in demand

Do you want to work at an exciting Swedish biotechnology company that is a world leader in diarrhea vaccine against ETEC – the leading cause of tourist diarrhea and diarrhea disease in children in low-income countries. Scandinavian Biopharma is now looking for a Director Manufacturing to lead the Manufacturing function at the company. In this role, you lead employees and consultants in the team and are overall responsible for coordinating and collaborating with external contract manufacturing partners (CMOs) for the production of the company’s vaccine products. You are offered stimulating work with both strategic and operational elements in an organization where the decision paths are short and the opportunity to influence is high. You will have an important role in the company and are part of the company’s management team. At Scandinavian Biopharma we are a close-knit team with a good community and with an exciting journey ahead of us – we hope you want to join us on this journey! The position is a permanent position with placement Solna. Selection and interviews are ongoing so we welcome your application today! The Manufacturing business area at the company is responsible for establishing cooperation with global CMO networks to ensure the production of our vaccine products. As Director Manufacturing, you are offered a qualified and developing position with overall responsibility for results, staff, goals and efficiency improvements. The position as Director Manufacturing includes:

  • Lead the Manufacturing function with today 3 employees and 3 consultants
  • Responsible for production at contract producers CMO for manufacturing for both clinic and future commercial manufacturing
  • Lead projects in tech transfer of production to CMO
  • Search for suitable CMOs, produce specifications and evaluate CMO
  • Practically be able to write/review tech transfer documents such as:
    Tech transfer plans and reports, Flow schedules and Manufacturing methods, Validation plans, Batch protocols, etc.
  • Compile and evaluate results from production at CMO
  • Work with the clinical team at the company to optimize supply to future clinical studies
  • Write/review regulatory documents included in cmc

Who are you? We are looking for you who have:

  • Master of Science in Biotechnology or equivalent
  • Many years of experience from pharmaceutical production of biotechnological
    medicines, for example mainly cultivation / purification, preferably also fill & finish
  • Experience from working in tech-transfer projects, qualification and validation in pharmaceutical production
  • In-depth knowledge of cGMP manufacturing of biological pharmaceutical products and regulatory requirements
  • Good knowledge of Swedish and English, in both speech and writing
  • Experience of working in small companies is a merit

We are looking for you who want to lead and develop dedicated and competent employees in the field of Manufacturing at an entrepreneurial company. You are structured, analytical and can handle complex issues with a detail focus. You are stimulated by both strategic and operational work and value creating good and long-term relationships with those you collaborate with. The role requires that you can get a good overview, follow up on activities within Manufacturing and be well prepared to help ensure that the different projects reach their goals according to the time, budget and quality. You are entering an exciting stage where your skills and ideas will make a significant difference to our world-leading ETEC vaccine project. A vaccine that will make a real difference and meet a large medical need in both children in low- and middle-income countries
and travelers About the businessEtvax AB is a subsidiary of Scandinavian Biopharma and conducts research and development, primarily in the field of vaccines against infectious diseases. The company is developing its own vaccine against tourist diarrhea caused by ETEC for both travelers and children in endemic areas. The employees have many years of experience in research on various pathogenic microorganisms. The work is carried out in well-equipped laboratories spread over approximately 500 sqm. General laboratories are available for the development and validation of analytical methods, for characterization and documentation of products. Special laboratories are available for the cultivation of bacteria, chromatographic purification of proteins, cell culture and molecular biology work. The work is carried out, where necessary, in accordance with applicable quality regulations (GXP, ICH). For more
information:
http://www.Scandinavianbiopharma.Se

About the employment

Salary type:
Fixed monthly, weekly or hourly pay

The workplace is located in the municipality of Stockholm in Stockholm County.

Apply by January 9 at 10:59 PM (in 21 days)

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