4 days ago

Senior QC Project Lead Maternity cover

Ichnos Sciences S.A.

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COMPANY OVERVIEW
 

ICHNOS Sciences is an independent, fully integrated, global U.S.-based biotech company focused on innovation.

“Ichnos Sciences - takes its name from an ancient Greek ?χνος - /’ík-nos/, which means “footprint” and is dedicated to transforming how people think about and treat cancer, autoimmune deceases and pain, and to leaving an imprint on the lives of those affected by disease,” Dr. Alessandro Riva, MD, CEO of Ichnos Sciences and former Gilead executive said.

The company takes a holistic, disease-centric approach to research, has been structured to work faster, smarter and more collaboratively to accelerate development and quickly bring new treatments to patients.

Our Swiss operation encompasses two biological R&D Centers and a GMP manufacturing facility and focuses on the discovery and development of novel biological entities and drugs comprising monoclonal antibodies and proprietary bispecific format in the field of immune-oncology and autoimmune diseases.

Overall we currently have three assets in the clinic in various stages of development from Phase 1 to Phase 2b. We also have multiple discovery programs based on our proprietary technology platform, BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor). Our molecules and drugs under developments target treatment among others of HER2 positive cancers, multiple myeloma and other malignancies of hematopoietic origin, as well as a variety of solid tumors.

We are looking for highly motivated people who thrive on being challenged and working in an agile, collaborative and multicultural environment to join our multidisciplinary discovery team and play a key role in conducting rigorous, cutting-edge science.

To partake in execution and enrichment of our ambitious pipeline of projects, we are seeking to hire a Senior QC Project Lead as part of the Quality Control team.

 

ROLE OVERVIEW
 

This position serves as a point of client contact for Quality Control/Analytical aspects of a project from beginning to end with accountability for assigned project deliverables. This role reports directly to the Team Leader: QC Projects .

Senior QC Project Lead Maternity cover

COMPANY OVERVIEW
 

ICHNOS Sciences is an independent, fully integrated, global U.S.-based biotech company focused on innovation.

“Ichnos Sciences - takes its name from an ancient Greek ????? - /’ík-nos/, which means “footprint” and is dedicated to transforming how people think about and treat cancer, autoimmune deceases and pain, and to leaving an imprint on the lives of those affected by disease,” Dr. Alessandro Riva, MD, CEO of Ichnos Sciences and former Gilead executive said.

The company takes a holistic, disease-centric approach to research, has been structured to work faster, smarter and more collaboratively to accelerate development and quickly bring new treatments to patients.

Our Swiss operation encompasses two biological R&D Centers and a GMP manufacturing facility and focuses on the discovery and development of novel biological entities and drugs comprising monoclonal antibodies and proprietary bispecific format in the field of immune-oncology and autoimmune diseases.

Overall we currently have three assets in the clinic in various stages of development from Phase 1 to Phase 2b. We also have multiple discovery programs based on our proprietary technology platform, BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor). Our molecules and drugs under developments target treatment among others of HER2 positive cancers, multiple myeloma and other malignancies of hematopoietic origin, as well as a variety of solid tumors.

We are looking for highly motivated people who thrive on being challenged and working in an agile, collaborative and multicultural environment to join our multidisciplinary discovery team and play a key role in conducting rigorous, cutting-edge science.

To partake in execution and enrichment of our ambitious pipeline of projects, we are seeking to hire a Senior QC Project Lead as part of the Quality Control team.

 

ROLE OVERVIEW
 

This position serves as a point of client contact for Quality Control/Analytical aspects of a project from beginning to end with accountability for assigned project deliverables. This role reports directly to the Team Leader: QC Projects .

RESPONSIBILITIES
 

  • Manage the development, validation and transfer of analytical test methods (compendial and non-compendial), specification setting and stability programs for clinical, late stage biologics product development in accordance with ICH/FDA/EMA/USP/Ph. Eur. or relevant guidelines

  • Develop and lead internal analytical technology transfer of projects into the Quality Control department, and external analytical transfer of projects to CMO/CROs.

  • Identify and track critical path/activities and risks, develop contingency and alternative plans and provide regular updates to the relevant CMC Project Lead and Team Leader: QC Projects.

  • Participate in project team meetings as assigned, and if required mentor/coach junior analytics team members.

  • Prepare project Gantts and inputs to the overall project Gantt in consultation with the Team Leader: QC Projects, CMC Project Management, and Head of Quality Unit to obtain the commitment to deliver on the timelines and Support analytical strategy.

  • Work with Team Leader: QC Projects, CMC Project Lead and Head of Quality Unit to ensure resources are committed and available to execute.

  • Interface with other clients (Regulatory Affairs, Discovery, Process Sciences, MSAT, QC, QA, CMO/CRO etc.) as necessary.

  • Participate in CQA identification, and perform FMEA analysis with respect to analytics.

  • Execute technical review of analytical data, and laboratory documentation, method validation protocols, method validation summary reports, method development reports, and similarity/comparability assessments.

  • Author, update, and revise CMC regulatory filing sections to support regulatory filings as required.

  • Ensure compliance with cGMP such that the products are assessed to agreed-upon specifications in a timely manner in order to support in-process, lot release and stability testing

  • Perform deviation investigations and CAPA implementation in support of CMC QC projects and improvement as required

  • Champion, lead or participate in continuous improvement activities.

  • Track action items, prepare meeting agendas, coordinate activities and disseminate project information.

  • Perform similarity assessments for biosimilars as required.

  • Perform other relevant duties as required.

 

EDUCATION AND DESIRED EXPERIENCE

 

  • PhD or equivalent immunology, biochemical engineering, biochemistry, biology or related discipline
  • Minimum of 5 years biologics experience in an industrial setting under GMP standards; CMO experience is a plus
  • Relevant Process and QC experience and knowledge of current early and late stage analytical techniques including for process characterization/validation.
  • Excellent communication skills and strong diplomacy skills required.
  • Strong knowledge/awareness of FDA, ICH, and USP guidance and regulations.
  • Knowledgeable in US and EU CMC Analytics requirements for submission (for IND, IMPD, BLA etc.)
  • Fluency in English, both written and verbal; French is a plus.
  • Proven ability to work with flexibility in a changing and demanding environment.
  • Ability to work independently as well as part of a team
  • Demonstrated success with problem analysis/solving, anticipation and proactivity.
  • Strong sense of discipline and initiative, exceptional planning and organization skills, excellent team and client orientation, and a hands-on approach to work.

LOCATION

You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint…

Route de la Corniche 5 1066 Epalinges