GMP Downstream Process/Purification Supervisor
Glenmark Pharmaceuticals S.A. - La Chaux-de-Fonds
15.05.2019 | Employee | 100%

Glenmark Pharmaceuticals ( www.glenmarkpharma.com ) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.

 

Glenmark’s Biologics Research Operations in Switzerland focus on the discovery and development of new biological entities from inception through preclinical and clinical studies.   With a world-class, GMP-certified manufacturing line, our Swiss site located in the Canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a full suite of in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as up- and downstream development.

 

Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

GMP Downstream Process/Purification Supervisor

In this role, you will manage all operational aspects of the Downstream Process linked to the production of BDS under cGMP conditions for clinical trials  from phase 1 to commercial . This position  will report  directly under the responsibility of the Head of Manufacturing inside MSAT department .

 

RESPONSIBILITIES:

 

Ensure the successful GMP production of BDS :

  • Organization of the pre-campaign period (check list and raw material ordering).
  • Keep spending within the pre-defined OPEX budget for single use material.
  • Select and implement new equipment for purification step within CAPEX budget.
  • Assist the Site Engineers for the maintenance and qualification of DSP equipment
  • Manage drafting, review and finalization of all relevant documentation (MBR, LB, etc.).
  • Manage DSP operations within the BDS production campaign adhering to production plan and with a minimum of deviations according to internal procedures (cGMP, HSE rules, etc.).
  • Manage the organization of the transfer of material to DSP during production.
  • Ensure that all the actions related to DSP operations and necessary for the release of the batch are completed in a timely fashion.
  • Ensure troubleshooting in case of unexpected issues that can impact the production
  • Support all deviations raised during the production runs.
  • Management of supplier relationships.
  • Assist in the organization of regular meetings, drafting of minutes and timely follow up of actions.

Manage the DSP team to ensure purification step of BDS production :

  • Manage resource allocation and ensure staff training for each campaign.
  • Supervise daily production tasks to team member and all purification operations are initiated according to timelines for each campaign and internal project.
  • Define yearly objective ,development plan and ensure performance evaluations for DSP team
  • Develop continuous improvement and lean process.
  • Support the recruitment of Manufacturing  team.

 

Manage stock and life of chromatography resins , ensure packing columns method and monitoring use of chromatography columns.  

 

Ensure efficient coordination inside MSAT department (USP team, Site engineers, Warehouse team)  and between DSP team and  other departments (QA/QC/Technical Operational/Development)

Prepare and participate to internal and external audit inspection (Swissmedic, FDA…)

Participate and support the CMC project meeting and participate towards the tech transfer process between Development and technical  transfer and QA/QC team.

Report to the GMP operations manager on a regular basis all operational issues and transmit efficiently all relevant decisions to the DSP group.

 

Participate in the alarm on-call rotation Facility/GMP area monitoring.

 

 

 

REQUIREMENTS:

  • MSc or equivalent with at least 5 years relevant industrial experience in DSP operations (development or manufacturing).
  • Experience in antibody and protein production with single-use process is a plus.   
  • Knowledge of regulations and guidelines pertaining to cGMP and strong GMP awareness
  • Strong leadership skills, a developed team spirit and an 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
  • Fluency in French and English, both written and verbal

15.05.2019
Employee, 100%

Contact

Glenmark Pharmaceuticals S.A.
Caroline Saint Marc
Chemin de la Combeta 5
2300 La Chaux-de-Fonds
No recruitment agencies please
Glenmark Pharmaceuticals S.A.
Chemin de la Combeta 5
La Chaux-de-Fonds

Industry

Biotechnology / Chemistry / Pharmaceutical

Year of foundation

2004
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