Posted: Thursday, March 15, 2018 7:06 AM
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for Senior Scientist - Technical Launch Integrator. This position can be located in Raritan, NJ, Titusville, NJ or Horsham, PA.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Senior Scientist - Technical Launch Integrator, you will:
â¢ Provide technical drug product support and ensure fit for plant and commercial readiness during technical development and execution of pharmaceutical processes and products transfer into the Supply Chain and the global market place.
â¢ New Product Introduction for the Pharmaceutical Manufacturing Platform providing oversight to technical transfer activities at internal and external sites, ensuring a successful commercialization of Drug Product (DP), and providing input to the New Product Team (NPT) related to additional projects to fully optimize the manufacturing and packaging processes post launch.
â¢ Lead technical and manufacturing integration of new and re-developed drug products from Research & Development (R&D) into the Supply Chain (large and small molecule).
â¢ Guide and lead the drug product manufacturing site team and be the manufacturing site representative.
â¢ Be the point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.
â¢ Provide JSC technical input and technical acceptance of drug product into the Supply Chain including cost and robustness metrics through a process of âtouch pointsâ, thereby ensuring âone voice of the customerâ towards R&D and consistency across projects and across plants.
â¢ Contribute, review and approve of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SMEâs) into project execution and technical implementation at the manufacturing site level.
â¢ Represent Technical Operations and the technical team in the various forums such as New Product Team (NPT), Drug Product Development Team (DPD) and Value Stream Team (VST), own the coordination of all product related technical activities and participate in development of long term supply strategy including scenario development and E2E impact analysis.
â¢ Collaborate with R&D, site functions and finance to identify improvement opportunities.
â¢ Monitor technical process and product performance and support failure investigations (escalation of quality or compliance events).
â¢ A bachelorâs or higher degree in Science, Engineering, Pharmacy or related field is required. Post graduate degree is highly preferred.
â¢ At least six (6) years of related experience in the health care industry is required.
â¢ Experience in pharmaceutical development or pharmaceutical manufacturing is required.
â¢ Experience in solids manufacturing processing requirements/techniques is required.
â¢ Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of manufacturing site unit operations is required.
â€¢ Project management knowledge is required. FPX training and project management certification is preferred.
â¢ Planning and logistics skills, and the ability effectively integrate drug product deliverables and support detailed execution at the manufacturing site level is preferred.
â¢ Knowledge of manufacturing site systems and procedures (SAP, event and complaint handling, change control, qualification, process validation and Continued Process Verification, etc.) is preferred.
â¢ Good knowledge of compliance and regulatory requirements, Good Manufacturing Practices (GMP) and Environmental Health & Safety is required.
â¢ Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams required.
â¢ Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required. As well as, the ability to work independently and solve problems effectively.
â¢ This position can be based in Raritan, NJ, Titusville, NJ or Horsham, PA and requires up to thirty percent (30%) of domestic and international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Titusville
JANSSEN SUPPLY GROUP, LLC (6046)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=4277180223&lang=en
• Location: Raritan, Staten Island
• Post ID: 162979382 newyork