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Investigator Associate
Do you have a passion for problem-solving, a nose for science, and do you like to work in an innovative environment? As an Investigator Associate, you'll lead critical manufacturing studies, enforce top-notch GMP standards and drive continuous improvements. If this sounds like you, then we want you on our team!
Job
As a pivotal figure within our Manufacturing Science and Technology (MS&T) team, these are your responsibilities:
Lead production investigations: You will conduct thorough production investigations within our manufacturing process in accordance with GMP standards and regulatory requirements to ensure timely and safe product releases. Working with multidisciplinary teams, you quickly identify and resolve root causes of incidents, implementing robust corrective and preventive actions (CAPAs).
Act as SPOC for regulatory agencies: You will serve as the primary contact for regulatory agencies during inspections and defend investigation strategies and reports.
Drive continuous improvement: You champion the research process and methodology and implement process improvements based on lessons learned. One of your missions is to reduce recurring deviations by leading challenging trend investigations.
Build strong partnerships: You liaise with various stakeholders to ensure efficient execution of process validation and production schedules. You facilitate seamless knowledge transfer between functions and locations for effective problem solving.
Profile
Education: You have a master's degree in engineering, science, pharmacy or a related field of study or you are equivalent through experience.
Experience: You have at least 3 years of operational experience within a cGMP environment in the biotech or pharmaceutical industry, preferably within cell and gene therapy.
Languages: You are fluent in Dutch or English, with strong oral and written communication skills.
Strengths: You are a born team player with strong analytical, problem solving and relationship skills. Your positive, proactive and results-oriented attitude is what really typifies you. Even in a fast-paced environment and under stressful conditions, you know how to keep your cool and meet critical deadlines.
Expertise: You have thorough knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. You have a razor-sharp scientific pen.
Benefits
- A job with impact that directly contributes to the well-being of patients worldwide.
- An excellent work-life balance.
- A supportive and innovative work environment. We value and encourage learning and personal development.
- The opportunity to work with people from all over the world.
- A permanent contract and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
- Many fun and informal events.
Company profile
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for hard-to-treat diseases like cancer.
Since our founding in 2014, we have expanded to over 2,000 employees across six global manufacturing facilities, with our headquarters in New Jersey.
In Ghent, we specialize in producing advanced CAR-T therapies for multiple myeloma, in partnership with Johnson & Johnson.
