Job Title: Associate Scientist QC Raw Materials
We are recruiting for an Associate Scientist QC Raw Materials at Johnson & Johnson Innovative Medicine Bern.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Job Description
The QC Raw Materials team is involved in the qualification and validation of various test methods and the performance of sampling and routine release tests for raw materials used in both clinical and commercial production phase. The methods used for routine release tests include qualitative and quantitative analysis tests, ranging from wet chemistry tests (e.g., Ion ID test, TLC, Titration, …), to instrumental analysis tests (e.g., FTIR, pH, Conductivity, Density, Refractometry, Osmometry, …).
Responsibilities:
1. Performs timely and cost-effective analytical tests of raw materials according to internal (TMDs) and/or external (e.g., EP, USP, JP, ISO) requirements.
2. Operates efficiently analytical instruments and supports equipment periodic maintenance and calibration tasks timely execution.
3. Supports raw material sampling activities, i.e., sampling, cleaning, monitoring.
4. Supports training and qualifications of team personnel.
5. Supports timely and effective completion of lab events, investigations and CAPAs related to OOS and non-conformances.
6. Performs laboratory duties to support department objectives.
7. Supports method qualification, verification and validation activities, if required.
8. Writes technical documents, e.g., Verification/Validation plans, Reports, ….
9. Supports laboratory management activities, e.g., planning activities covering end-to-end raw materials process.
10. Leads and supports continuous improvement projects within Quality Control in operational efficiency and GMP compliance.
11. Complies with all applicable health, safety and environmental regulations, processes and guidelines.
12. Provides support to analytical development, process development and other stakeholders when the need arises.
13. Supports inspection preparations, execution and follow-up.
14. Supports building and expanding a strong team.
Requirements:
1. University degree in natural sciences, applied sciences, or equivalent and work experience in the pharmaceutical, biotech or vaccine industry.
2. At least 3 years experience in a cGMP regulated environment and competence in microbiology techniques.
3. Solid knowledge of analytical laboratory operations and practices.
4. Well organized, a self-starter, results oriented individual with the ability to multitask in a fast-paced team environment with attention to detail and good documentation practice.
5. Strong strategic and conceptual skills, analytical thinking and problem-solving ability.
6. Good communication abilities.
7. Proactive attitude that challenges the status quo, team player and team builder.
8. Ability to manage multiple projects, tasks and assignments simultaneously and prioritize accordingly.
9. Able to work independently and take ownership of assigned task to plan and execute according to agreed deadlines.
10. Good IT user skills.
11. Good verbal and written skills in English and German.