Director CMC, Drug Product

Director CMC, Drug Product

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 formulation scientist. 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 at 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 Clinical development.

The main responsibilities are:
  • Development of a formulation strategy for each of Galecto's new chemical entities in pre-clinical and clinical development
  • Management of Galecto Biotech's outsourced formulation development activities including pre-formulation testing and development of formulations for nonclinical testing (toxicology and in vivo animal models) and Phase I clinical trials as well as formulation optimization/modification for later stage clinical trials
  • CDMO selection including generation of RFP and review of submitted bids/proposals
  • Providing scientific input and guidance to the CDMO on pre-formulation testing, development of a phase-appropriate formulation and supportive analytical method development activities
  • Coordination of development activities with internal project teams to ensure phase-appropriate formulations available for non-clinical toxicology and in vivo animal testing as well as to support manufacture of clinical trial material for clinical trials
Ideally, you hold a relevant university degree – preferably a MSc in Pharmacy or Pharmaceutical Technology or related science.

The successful applicant will already have a proven record of accomplishment in delivering the formulation strategy for new chemical entities in pre-clinical and clinical development. The following qualifications are preferred:
  • Minimum 5 years of experience in formulation development for pharmaceuticals
  • Expertise in solid oral dosage form development
  • Experience in formulation development for toxicology studies
  • Experience or knowledge of parenteral, dermal, inhalation and other types of formulations is an asset
  • Up to date knowledge of innovations in formulation development
  • Solid understanding of the drug development process
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.
Mer info
Område Göteborgs stad
Yrkesroll Hälsa & Sjukvård, Medicin & Farmaci, Medicinsk forskning & Laboratorieverksamhet
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 5 feb 2021 (14 dagar kvar)

Om arbetsgivaren

Galecto Inc. is a clinical stage biotechnology company committed to the development of novel small molecule therapeutics directed at biological targets which are at the heart of fibrosis, inflammation, and cancer. It has recently raised $64 million and has completed a successful IPO to accelerate development of its clinical pipeline and support preparations for potential EU conditional approval of GB0139 in IPF and multiple new Phase 2 clinical trials.

Galecto was founded by leading fibrosis-focused scientists and biotech executives and is built on more than 10 years of research into galectin and fibrosis modulators. The team has developed a deep understanding of the galectin family of proteins and the LOXL2 enzyme, and how both influence multiple biological pathways of these complex, often devastating, diseases.