Senior Scientist Bio-/Chemical Quality Control

Work Schedule

Environmental Conditions

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 timelines
• Review and approve methods, plans, protocols, and reports
• Supporting procurement, qualification, calibration, and maintenance of analytical and infrastructure equipment
• Coordinate the development, transfer, and validation of analytical procedures according to given timelines
• Review 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 initiatives
• Promote effective and timely communication within project teams, ensuring visibility and understanding of the site/company's strategy
• Support project implementation within the QC department and ensure data-driven workload for each assigned project
• Drive project collaboration and operate in full alignment with the company's core values
• Own the problem-solving process for any issues related to assigned projects/tasks
• Coordinate resources in collaboration with the rest of QC, ensuring QC timelines and targets are met
• Promote an accountable working environment through management mentorship and open access to important information
• Proactively support continuous improvement of QC compliance and performance
• Establish and maintain contact with external partners such as suppliers, contract laboratories, and universities

QC Execution:

• Document and deposit raw data, results, reports, and journals
• Assist during the resolution of issues and requests related to (bio)chemical analytics (quality issues, health authority requests, etc.)
• Ensure timely investigation of deviations
• Communicate efficiently and inform the head of BCQC about ongoing business and issues
• Sharing required information with sponsors, customers, and colleagues
• Supporting QC colleagues in the areas of GMP and Quality Control
• Supporting recruitment within the team
• Acting 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 management
• confirmed experience (at least 5 years) in chemical or biochemical laboratories, including experience in a regulated GMP environment
• experience in project and task coordination

Proficiencies:

• Business insight and critical thinking
• Emphasis on achieving goals and taking ownership
• Effective communication skills
• Strong collaboration abilities
• Agility 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.