Biotechnology Projects Coordinator

POSITION AVALIABLE

Biotechnology Projects Coordinator

Preclinical Development Department CELON PHARMA S.A.

 

In relation to the realization of the research projects under Smart Growth Operational Program 2014-2020, axis 1.1, 1.2 , 4.1 and strategic program STRATEGMED, we hereby announce the recruitment for: Biotechnology Projects Coordinator position in the Preclinical Development Department in Celon Pharma S.A.

Major Responsibilities:

  • Management of the discovery and development processes of novel drugs, biotherapeutics, in a cooperation with different multidisciplinary teams and a close connection to project background and rationale.
  • Setting up and managing of interactions with CMO and CRO organisation.
  • Preparation of scientific advice procedures as well as IMPD and IB packages.
  • Plan, seek and agree with management the resources necessary to carry out the project.
  • Coordinate and oversee research and development projects under His/Her responsibility, whether entirely within the company, institution or in collaboration with external companies/institutions. In the latter case, work in conjunction with the project manager assigned by the other company or institution.
  • Identify strengths and weaknesses of the project, detect deviations, perform risk analyses and propose corrective actions.
  • Coordinate and supervise the work teams assigned to the project, whether internal, external or subcontracted.
  • Act as a liaison between external agents like institutions, clients and/or suppliers.
  • Design and perform binding studies for the evaluation of biotherapeutics and protein reagent activity.
  • Design and perform experiments for the assessment of drugs developability.
  • Present results regularly at team meetings.
  • Analyse, interpret, summarize and report experimental data.

Requirements:

  • PhD or Master degree in the field of Biochemistry, Biophysics, and/or Chemistry-related discipline, ideally focused on protein structure and function.
  • In-depth knowledge of the regulatory requirements (safety/efficacy and manufacture) of biologics and biosimilars.
  • Experience in design and preparation of IND packages for biologics and biosimilars – EMA or FDA.
  • Experience in preclinical development of biologics and biosimilars.
  • Experience in reviewing, developing and presenting the nonclinical efficacy/safety data as well as production (up and downstream) and characterization processes.
  • Strong expertise in design, execution, and troubleshooting of protein assays, like: SPR-based, thermal shift-based, protein expression, protein purification, molecular cloning, recombinant protein design and development, efficacy/activity screening methods/assays.
  • Demonstrated experience and track record in the protein development area.
  • In-depth knowledge of drug discovery processes for biologics and biosimilars with solid expertise in protein biochemistry and pharmaceutical biotechnology.
  • Familiarity with high-throughput screening assays for biologics.
  • Industry experience is a prerequisite.

General requirements:

  • Proven ability to design, execute and interpret experiments.
  • Proven ability to work in the demanding pharmaceutical environment.
  • The ability to work independently and collaboratively with diverse multidisciplinary teams.
  • Excellent written and oral communication skills.

What we offer:

  • Participation in the R&D projects focused on novel drug candidates.
  • Opportunity to participate in all preclinical stages of drug development process.
  • Work in a dynamic, young and interdisciplinary project team.
  • Collaboration with the excellent institutes in Poland and worldwide.
  • Opportunity for career development.
  • Full-time employment and job benefits.

Candidates are asked to send their applications (CV and a motivation letter in English) to: [email protected] within 30 days from the date of the announcement. We kindly ask to add in the subject of an email: Biotechnology Projects Coordinator. We announced that we contact selected candidates only.

 

We kindly ask to enclose the agreement:

“I hereby give consent for my personal data included in my application to be processed for the purposes of the recruitment process under the Personal Data Protection Act as of 29 August 1997, consolidated text: Journal of Laws 2016, item 922 as amended.”