Senior Scientist Bio-/Chemical Quality Control
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Senior Scientist Bio-/Chemical Quality Control
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Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Product Management, and Engineering
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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