Johnson & Johnson's Innovative Medicine is recruiting for a Scientist in the Global Process, Biotherapeutic’s Drug Product Development and Delivery organization, located in Schaffhausen, Switzerland.
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.
The candidate for this position will be responsible for process development and technology transfer of fill/finish manufacturing processes of biotherapeutic products. The candidate will also work with colleagues in MSAT, Quality, Regulatory, and other functions to ensure manufacturing processes meet all regulatory requirements and expectations.
Primary responsibilities:
1. Lead late-stage process development, technology transfer, process validation, and filing activities both to and between manufacturing sites (internal/external network) by providing scientific support and technical project management.
2. Author tech transfer documents such as process validation protocols and reports, criticality analysis, and regulatory submissions in a timely manner.
3. Collaborate with cross-functional groups to ensure processes are consistent with accepted Janssen platforms and compliant with submitted CMC dossiers and cGMP regulations.
4. Provide feedback to development teams regarding technical performance and consistency with Janssen's process development approach.
5. Participate in parenteral networking to ensure seamless transfer of drug product manufacturing processes from lab to pilot to commercial scale.
Qualifications:
* Technical expertise in current and future manufacturing principles and processes, preferably related to large molecule fill and finish.
* Experience in biologics drug product development within the biopharmaceutical industry is required.
* Knowledge of drug substance and/or drug product processes.
* Experience with biopharmaceutical process design, technology transfer, and fill/finish operations is preferred.
* Experience with container-closure systems like vials, syringes, and delivery devices is preferred.
* Ability to work collaboratively in cross-functional teams.
* Excellent oral and written communication skills in German and/or English.
* Motivated, autonomous, with strong problem-solving skills.
Degree:
Master's degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy, or a related field with at least 4 years of experience OR PhD in the same fields with up to 3 years of experience.
Physical requirements/working conditions: Travel 10-30% depending on the project.
Johnson & Johnson values diversity, equity, and inclusion (DEI), embedding these principles into our culture and business practices. We strive to create an inclusive environment where all employees feel valued and can reach their full potential. "You Belong" at Johnson & Johnson.
For more information, contact Frau Gjulnara Kasimova, Sr. TA Partner. Write an email
#J-18808-Ljbffr