Janssen Research & Development, LLC., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Biotherapeutics Development and Supply (BTDS), API-Proteins, Material Sciences located in Malvern, PA, Spring House, PA, Raritan, NJ, or Titusville, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Material Sciences is a technical, scientific department within Janssen BTDS organization. We are expanding our team to strengthen our connectivity to and experience within raw materials used in our broad biotherapeutics portfolio. Our department is responsible for:

• Application of science and risk-based approaches to the characterization and qualification of raw materials for the R&D and Supply Chain biopharmaceutical product portfolio of monoclonal antibodies, conjugated monoclonal antibodies, radiopharmaceuticals, gene and cell therapies and vaccines;
• Identification of critical material attributes and definition of control strategies for raw materials and implementing these during the CMC development cycle;
• Proactively participate as Scientific Integrators in our cross-functional CMC teams supporting phase-appropriate development leading to effective technology transfers and successful regulatory filings;
• In partnership with procurement and quality, plan and execute technical due diligence assessments and visits with raw material suppliers and contract manufacturing organizations (CMOs);
• Development of specifications and qualification plans for cell culture media, buffers/chemicals, process chromatography resins, cell selection and activation reagents, adjuvants, excipients and polymeric product contact materials including filters, bags and tubing;
• Support of technology transfer and site readiness for raw materials at clinical and commercial manufacturing sites including internal sites and CMOs;
• Investigation of complex material-related product and process deviations and manufacturing investigations.

This position will require the ability to work independently, be self-motivated, be collaborative to build a strong foundation and operate in a cross -functional environment. The pay grade for the position may be adjusted based on the candidate’s qualifications. This position may be site based, based on candidate’s fit and experience.

If you have the leadership (matrix and direct reports), scientific integration and technology transfer experience in biologics, vaccine, cell or gene therapy process and are looking for a dynamic opportunity to lead our scientific integration and technology transfer for raw materials, define and implement control strategies and support regulatory filings and inspections across a range of development programs and commercial products within the expanding Janssen Biologics portfolio, this opportunity is for you!

Main responsibilities include:

• Lead (direct reports and matrix team members) supporting scientific integration within CMC teams, technology transfer and supply chain projects.
• Design and implement robust and operationally efficient business process methodologies and tools to promote a robust portfolio level management of projects.
• Lead team of scientists and engineers supporting the development, qualification controls and transfer of raw materials including internal laboratories and contract laboratories.
• Collaborate with technical and quality partners at CMOs on the definition of controls for raw materials including support of supplier and material qualification.
• Partner with API Protein/CGT and Drug Product development teams for material selection, assessments, and control strategies.
• Support technology transfer of materials used in the clinical and commercial supply chain throughout product life cycle partnering closely with technical, procurement, regulatory and quality partners.
• Participate in cross-functional CMC teams and sub-teams.
• Interpret and implement industry and regulatory guidance for raw materials, e.g., USP/EP/JP, ICH, FDA and EMA. Ensure safety and compliance with GMP, quality, and scientific principles. Author, review and approve raw material sections of regulatory documents for global filing of Janssen biotherapeutics drugs.

Qualifications

Education:

• A Bachelors in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 12 years of experience OR a Masters with at least 10 years of experience OR Ph.D. degree in the above disciplines with at least 8 years of experience is required

Required

• Microsoft office proficiency in Excel, Word, PowerPoint are required.
• Demonstrated experience working effectively in matrix team is required.
• This position will be based in Malvern, PA, Spring House, PA, Raritan, NJ, or Titusville, NJ and may require up to 10% international and domestic travel.

Preferred:

• Demonstrated proficiency leading direct reports in complex technical projects is preferred.
• Demonstrated experience in CMC development activities for biotherapeutics is preferred.
• Demonstrated proficiency in knowledge of raw materials including cell culture media, chemicals and excipients in biotherapeutic products is preferred.
• Demonstrated competency and experience in quality investigations, change control, troubleshooting and regulatory submissions is preferred.
• Demonstrated experience with managing contract laboratories is preferred
• Demonstrated competency and experience in product/process (CMC) development, technology transfer, or investigations within the biopharmaceutical industry is preferred.

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.