Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Technical Responsibilities

Processes and methods implementation:

Coordinate actions to establish and implement processes and analytical methods for testing finished products, in-process controls, intermediates, raw materials, utility, and cleaning samples.Responsible for:Write and revise standard operating procedures (SOPs) and work instructions (Wis) within timelinesReview and approve methods, plans, protocols, and reportsSupporting procurement, qualification, calibration, and maintenance of analytical and infrastructure equipmentCoordinate the development, transfer, and validation of analytical procedures according to given timelinesReview of analytical raw data, equipment qualification/maintenance raw data, and other documentation in Biochemical QC.

Project Leadership:Represent BCQC in projects, workgroups, and participate in local and global initiativesPromote effective and timely communication within project teams, ensuring visibility and understanding of the site/company's strategySupport project implementation within the QC department and ensure data-driven workload for each assigned projectDrive project collaboration and operate in full alignment with the company's core valuesOwn the problem-solving process for any issues related to assigned projects/tasksCoordinate resources in collaboration with the rest of QC, ensuring QC timelines and targets are metPromote an accountable working environment through management mentorship and open access to important informationProactively support continuous improvement of QC compliance and performanceEstablish and maintain contact with external partners such as suppliers, contract laboratories, and universities

QC Execution:Document and deposit raw data, results, reports, and journalsAssist during the resolution of issues and requests related to (bio)chemical analytics (quality issues, health authority requests, etc.)Ensure timely investigation of deviationsCommunicate efficiently and inform the head of BCQC about ongoing business and issuesSharing required information with sponsors, customers, and colleaguesSupporting QC colleagues in the areas of GMP and Quality ControlSupporting recruitment within the teamActing as liaisons between their respective departmental teams and the DI officer, ensuring regular DI Surveillance and performing internal DI moments, huddles, and trainings

Position Qualification

Education:

Degree or equivalent experience (Master or higher) in biochemical, chemical, pharmaceutical, molecular sciences, or similar fields.Lower educational background may be accepted based on significant experience in the pharmaceutical industry.

Experience & Proficiencies:3-5 years lab experience with confirmed expertise in (bio)chemical QC methods, method validation, and analytical issue managementconfirmed experience (at least 5 years) in chemical or biochemical laboratories, including experience in a regulated GMP environmentexperience in project and task coordination

Proficiencies:Business insight and critical thinkingEmphasis on achieving goals and taking ownershipEffective communication skillsStrong collaboration abilitiesAgility and adaptability in handling ambiguity

Additional Requirements:Proficiency in English and German is required, with exceptions considered on a case-by-case basis based on the overall CV.