Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Position Purpose
This position plays a vital role in coordinating various aspects of the manufacturing
operations, ensuring the highest level of quality, safety, efficiency, and compliance. The
position holder partners with diverse teams and is tasked with
solving operational issues, driving process improvements, and supporting the successful implementation of new production lines and processes.
Position Responsibilities

• Provide support and solving in Drug Substance Manufacturing areas like USP, DSP, and Solution Preparation.
• Lead all aspects of as process owner equipment installation, maintenance, and calibration, ensuring top performance and alignment to industry standards
• Ensure quality, safety, and compliance by reviewing exceptions, supporting batch record reviews, and leading deviation investigations & CAPAs
• Represent operations in the development of facility, technology transfer, commissioning, and validation of new manufacturing lines.
• Drive continuous quality and process improvements using Practical Process Improvement (PPI) methodologies.
• Collaborate with various departments and represent DS Manufacturing in external interactions.
• Take personal accountability for presence, performance, and efficiency.
• Think and act with a customer-centric approach.
• Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
• Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.

Position Qualifications

• Bachelor/Master/PhD in Chemistry, Biochemistry, Biotechnology, Biology, or Food Science.
• Proficiency in English, German language skills are a plus.
• Minimum of 5 years of successful experience in pharmaceutical operations within a GMP relevant environment.
• Strong experience in biotech processes, with additional exposure to sterile processes, production equipment handling, or CIP/SIP processes.
• Proven track record to thrive in a matrix environment, collaborating with multi-functional teams and partners

Skills Required