Manager BU PAR NPI/LCM
Vor 3 Tagen
Job Description - Manager BU PAR NPI/LCM (2406225943W)
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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. Learn more at www.jnj.com.
As a Manager Parenterals New Product Introduction & Life Cycle Management, you are responsible for the end-to-end introduction of new products and implementation of new technologies and processes in alignment with tech transfer plans and business objectives. You will support innovation, cost improvement, and compliance projects in parenterals operations and assure robust and reliable implementation. Your responsibilities include support of inspections, filings, and health authority responses acting as subject matter expert for production related topics.
Job Responsibilities:- Execution and support of projects in New Product Introduction and Lifecycle Management in the Business Unit Parenterals.
- Act as a representative of operations and ensure that processes follow regulatory requirements and cover operational needs in terms of handling and lean procedures.
- Execution of feasibility studies in cross-functional teams.
- Execution and support of improvement projects.
- Responsible for change controls, recipe, and document changes.
- Handling of quality investigations concerning process and material deviations.
- Training of project related content on the shop floor and in leadership.
- Acts as Subject Matter Expert in project related audits.
- Close collaboration with production as well as with other relevant business partners.
- Follows GMP, EHS, and SOX guidelines.
- A minimum of a bachelor’s degree in natural science or engineering is required. Master’s degree preferred.
- Preferred 5+ years of experience in various fields in the Pharmaceutical industry, with a minimum of 5 years in a role involved in parenteral/pharmaceutical manufacturing or development.
- Preferably experience with introduction of parenteral products into manufacturing sites (biotechnologically produced and/or chemically synthesized APIs), late stage development activities as well as technical and process knowledge of manufacturing site unit operations (e.g., compounding, milling, and filling of liquid formulations and suspensions).
- Demonstration of leadership in providing oversight and guidance of manufacturing activities and sharing information within a diverse community of professionals and across multifunctional groups.
- Strong planning and logistics skills to effectively integrate drug product deliverables and execution at the manufacturing level.
- Knowledge of manufacturing site systems and procedures (e.g., SAP or equivalent).
- Excellent written and oral communication skills and ability to influence partners, peers, and collaborators at all levels.
- Proficiency in German and English is a requirement.
- Ability to work independently with proven problem-solving skills.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check our page for information on how to request an accommodation.
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