Leading the ramp-up and running of the stainless steel biologics production lines within the Drug Substance Manufacturing department (upstream, downstream, buffer/media, assemblies, equipment prep)
Building the GMP readiness of our operations and supporting the licensing of the Lengnau site
Responsible for planning of efficient utilization of workforce, equipment and material through effective production control techniques of both short and long term strategies to continually improve the operational efficiency of DSD manufacturing facilities
Development of stainless steel facility operations, ensuring GMP readiness and Swiss Medic inspection readiness
Responsible for producing the planned output of technical, engineering and commercial batches (volume, quality, time) within budget and in compliance with all applicable internal procedures, Swiss and international regulations as well as corporate standards and values
Supporting the transfer and implementation of product development projects from MSAT to standard commercial manufacturing procedures
Responsible to run a robust supply chain and logistics processes for facility
Leading a culture transformation within the manufacturing team to nurture empowerment, agile decision making, continuous improvement, PPI and excellence
Education
Master degree in a life science subject area, biotechnology, pharmacy, chemistry, biology or similar, PhD preferred
Good command of English is a must, German preferred
Confirmed experience (min. 10 years) in pharmaceutical operations, including familiarity with stainless steel operations and regulatory compliance, with specific experience in at least 2 of the listed areas: manufacturing operations, facility start-up, MSAT, QA, Supply chain
Prior experience in a start-up or greenfield environment with a consistent record, CDMO preferred
A minimum of 5 years leadership experience in operations in the pharmaceutical industry
Managerial experience and track record in operational management of a cGMP plant or manufacturing unit in the pharmaceutical, biotechnology, or biological industry
Excellent skills in communication, writing and public speaking
Capable of integrating project planning efforts across functions and handle many projects simultaneously
An organized team player that understands the “big picture” and approaches problem solving in a proactive team manner