Manufacturing USP Lead

Job content

Manufacturing USP Lead

Job Description

ROLE OVERVIEW

The Manufacturing USP Lead works under the responsibility of the Operations- Associate Director and takes part in all the operational and documentation aspects of the Upstream manufacturing activities pertaining to the production of Bulk Drug Substance (BDS). Manufacturing is performed under cGMP conditions in manufacturing facility dedicated for phase 1 and clinical studies.

Responsibilities:

• Management of the USP team

• Develop the USP team strategy, objectives and priorities in accordance with the department vision and goals

• Develop team members by providing the appropriate level of training, coaching and mentoring.

• Provide leadership with regards to tech transfer and USP manufacturing activities to ensure the production of high quality BDS in a lean manner in compliance with cGMP.

• Manage resources and resource demand for the USP team and proactively communicate gaps and solutions as appropriate. Ensure the recruitment of Manufacturing USP team.

• Ensure alignment and synergies with other functions within Ichnos Sciences such as QC, MSAT and QA.

• Ensure the implementation of new drugs project

• Represent the MFG USP in CMC meeting for all project to ensure timelines from DNA to IND.

• Participate towards the tech transfer process between MSAT and development group to anticipate changes.

• Lead/supervise process improvement with implementation of new equipment (supplier selection, URS , FAT, SAT, change control).

• Ensure all USP MFG activities for the start of the new campaign.

• Manage the generation/update of all relevant documentation (SOP, MBR; LB, etc.).

• Ensure an efficient link with warehouse, MSAT , process development and the quality groups (QA and QC).

• Assist in the organization of regular meetings, drafting of minutes and timely follow up of actions.

• Ensure the successful production of BDS

• Establish the operational planning for the production activity

• Supervise and perform all USP production operations according to cGMP rules within the BDS production campaign adhering to pre-defined timeline.

• Ensure that all the actions related to MFG operations and release of the batch are completed in a timely fashion.

• Support and lead all deviations raised during the production runs.

• Manage the maintenance and qualification of all USP/DSP equipment with the support of Engineering service.

• Support the logistical intendance of MCB and Product (shipment, communications, reporting etc).
• Participate to the recruitment of Manufacturing team. Provide backup to Associate Director for change implementation, deviation closure and team organization.
• Perform other relevant duties as required.

Education and Desired Experience:

· License, bachelor or Engineering degree in biotechnology, biochemistry or biology

· At least 3-5 five years of relevant industrial experience in USP operations (development or manufacturing).Experience in antibody and protein production and single-use process is a plus.

· Expertise in upstream process

· MCB/WCB knowledge is a plus

· Ability to work and collaborate in a strong team spirit.

· Demonstrated skill in organization, problem analysis/solving and proactivity

• · Fluent in French and able to use English language.

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…