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Director CMC, Drug Substance

 High degree of influence in a small but rapidly growing biotech company

 

Galecto Biotech is a biotech company with offices in Copenhagen, London, Montreal, Gothenburg, Edinburgh and Boston. Galecto Biotech develops galectin modulators for the treatment of severe diseases, focusing on fibrosis and cancer. The most advanced program is in clinical Phase IIb for the treatment of Idiopathic Pulmonary Fibrosis. 

As the CMC area within Galecto expands, they are looking for a highly motivated and skilled chemist to support CMC activities focused on API development and manufacture. This role offers the unique opportunity to be part of, and obtain experience in, the drug development process from preclinical through to the clinical phases in a dynamic and growing company.

You will report to the Chief Operating Officer in Galecto and work closely with colleagues within CMC, Medicinal Chemistry, Nonclinical and Formulation development.

The main responsibilities are:

  • Management of Galecto Biotech’s outsourced API activities including initial route identification and process development for new drug candidates through process scale up for the various stages of development
  • CMO selection at each stage of development including generation of RFP and review of submitted bids/proposals
  • Ensuring, with legal input, that appropriate contracts including MSA’s and QTA’s are in place and appropriate for the phase of manufacture
  • Providing scientific input and guidance to the CMO throughout the process development and manufacturing including supporting analytical development activities
  • Reviewing and approving the documentation generated by the CMO such as master batch records, specifications, validation and stability protocols and reports and campaign/development reports
  • Coordinating API manufacturing activities with internal project teams to ensure sufficient API available for nonclinical toxicology and efficacy studies as well as drug product development and manufacturing needs at the various stages of development
  • Communicating key information on project progress and risks to project teams and line management in a timely manner
  • Preparing CMC documentation for regulatory submission (IND Module 3, IMPD) and responding to API related regulatory questions
  • Ensuring compliance with current regulatory requirements via PGI and nitrosamine assessments and phase appropriate understanding of sources and purging of process impurities

Ideally, you hold a relevant university degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy, or the like. A PhD is preferred but not a requirement.

The successful applicant will already have a proven record of accomplishment in delivering APIs manufactured according to GMP to deadline and on budget. The following qualifications are preferred:

  • Minimum 10 years of experience with process development for the manufacture of pharmaceuticals in fixed assets
  • A strong understanding of organic chemistry
  • An understanding of the regulatory requirements for manufacture of API for different clinical phases
  • Experience with project management of CMC activities covering process development, analytical development, and plant manufacture
  • Experience with outsourcing projects to external CDMOs
  • Experience with training and growing a team

You are proficient in English on a professional level, both written and spoken.

You are an independent and self-motivated person with a proactive attitude towards your tasks and stakeholders. You are a team player and thrive in a flat structure with short lines of command. Your enthusiasm and creative problem solving leads to unique solutions and results. You are inquisitive, curious and able to acquire new skills as projects demand and you are willing to contribute wherever needed.

Galecto Biotech offers you an exciting and challenging position in an entrepreneurial, science driven and international company with a short line of command. You will be involved in activities that are central to Galecto’s strategy and work together with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 5 -15 days/year.

Place of work: Galecto Biotech is a global company and place of work can be in one of the Galecto offices in Copenhagen, London, Montreal or Gothenburg.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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