4 days ago

Senior Team Leader QA Operations

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 /’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 support execution of our ambitious pipeline of projects we are seeking to hire a

 

 

Senior Team Leader QA Operations

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 support execution of our ambitious pipeline of projects we are seeking to hire a

 

 

The role of the Senior Team Leader QA Operations is to manage the QA Operations team, ensure compliance of Drug Product used for clinical trials supply in collaboration with all relevant stakeholders (e.g. quality control, CMC lead, MSAT, clinical operation). Sr. Team Leader QA Operations report into the Head of Quality Unit/QP.

 

RESPONSIBILITIES :

 

  • Manage and lead QA operations team which includes development, education, coaching, training, yearly appraisals and follow-up, with continuous focus on improving work processes.
  • Manage overall QA operations activities of early and late-stage program clinical trial programs.
  • Review and approve deviations, CAPA, change control and OOS/Investigations.
  • Review validation studies, batch record, analytical records, and standard operating procedures.
  • Manage Bulk Drug Substance and Drug Product supply chain.
  • Assess product compliance, operational risks and develop risk management strategies. Advise internal management on the implementation or operation of compliance programs as appropriate.
  • Identify product compliance issues that require follow-up and/or investigation.
  • Disseminate and write policies and procedures related to compliance activities for early and late stage and M/WCB, drug substance and drug product.
  • Discuss emerging compliance issues with management or employees, CMO etc.
  • Provide assistance to internal or external auditors in compliance reviews.
  • Prepare management reports regarding compliance operations and progress.
  • Stay informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes.
  • Provide support to the QP for BDS and DP product specification file as per Annex 13 and Annex 16.
  • Perform other relevant responsibilities as required.

 

EDUCATION AND DESIRED EXPERIENCE:

  • MS or PhD biochemical engineering, biochemistry, biology, pharmacy or related discipline
  • Minimum of 5 years of relevant experience in late stage projects in an industrial setting under GMP
  • Relevant QA experience and knowledge of current Swissmedic, USP-, EP- and ICH guidelines.
  • Experience in quality control, biotechnology production, microbiology, analytics and manufacturing
  • Experience with change control, deviations, laboratory investigations and batch record review
  • Experience in stability programs as described in ICH guidelines.
  • Experience in Sterile manufacturing and supply chain management
  • Fluency in English, both written and verbal; French is a plus
  • Strong leadership skills and the 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 and a hands-on approach to work

 

LOCATION:

You will join our Swiss operation encompassing the company's Biological Development Centre located in the Canton of Neuchatel and focused on the development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. We provide an attractive, international and multicultural environment with career opportunities for scientists engaged in applied biomedical sciences. Located in a beautiful area of Switzerland, we are a rapidly growing company with an attractive and competitive early phase portfolio in the areas of immuno-oncology, respiratory and dermatology research.

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 the company leaving your scientific imprint…

Route de la Corniche 5 1066 Epalinges