Technical Project Lead - Basel, Schweiz - CTC Resourcing Solutions

CTC Resourcing Solutions

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Technical Project Lead - Pharma Manufacturing (DP ADA

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a
Technical Project Lead with expertise in Pharma Manufacturing (Drug Product).

You will establish Manufacturing Science and Technology (
MSAT) expertise across different equipment platforms for
Drug Product development & manufacturing with focus on
Parenterals.

You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.

This is a
contract based opportunity (1 year) with great chances of extension and based in
Schaffhausen, Switzerland.

Main Responsibilities:

Ensure timely
plant readiness to support experimental / clinical activities
Ensure timely
delivery of clinical material from internal pilot plants or from external contract manufacturing organizations (CMO)
Manage the overall relationship with internal/external manufactures and act as the single point of contact between the organization and the respective manufacturing site
Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
Support scaleup and Tech-Transfer
Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
Prepare business plan forecasts and monitor actual spend vs budget.

Qualifications and Experience:

-
Relevant working/residency permit or Swiss/EU-Citizenship required
:

You have a degree in Pharmaceutical/Biochemical/Life Science/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (5+ years) OR a PhD with proven experience (3+ years)
Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
Demonstrated proficiency and experience of biopharmaceutical process design is helpful
Solid understanding and experience of technology transfer operations is preferred
Solid understanding and experience in fill/finish operations is preferred
Experience in clinical or commercial manufacturing is required. Prior experience working with a CMO is preferred.
Ability to collaborate with crossfunctional teams is a must.
Excellent oral and written language skills in
German and English.