Job Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Analytical, Large Molecule Material Science, located in Malvern, PA or based remotely within the US

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Scientist selected will be responsible for analytical characterization of chemically defined media with focus on reviewing methods, specifications, validation protocols, managing contract manufacturing organizations’ s analytical testing timelines in the Biotherapeutics Development Sciences (BTDS) Material Sciences group part of Strategic Sciences and Technical Operations (SSTO). This scientist will be working primarily on Janssen Supply Chain (JSC) projects focused on dual sourcing of upstream & downstream raw materials for 2021-2022. This position can also be a 100% remote position based on candidate’s preference. This position will also require the ability to work independently, self-motivated, be collaborative to build a strong foundation and operate in a cross -functional environment. Acting as an analytical Subject Matter Expert (SME) this role entails numerous responsibilities and is described below.

Responsibilities:

Collaborate with BioTD Material Sciences, API Protein Upstream, Downstream and JSC teams for testing plans and establish raw materials controls in process and formulation design including, design, execution and/or lead experiments in support of raw material qualification.
Design and implement risk assessments for raw materials with suppliers and support internal efforts for identification and control of Critical Material Attributes.
Guide pharmaceutical development teams on the selection of materials based on scientific, quality, and regulatory criteria selection of materials for utilization in commercial, clinical, and regulatory criteria.
Lead and coordinate specification development for various materials including cell culture media, resins, excipients, and adjuvants.
Collaborate with raw material suppliers and internal partners to establish effective raw materials control strategies in upstream bioprocessing and fill-finish drug product sites.
Manage and improve Material Qualification process in close collaboration with partners in procurement, quality, and technical operations.
Coordinate analytical method development, testing and summarize progress and findings in weekly meetings within group and to external JSC functions.
Support raw material investigations from analytical perspective and life cycle activities related to raw materials including leading and/or participating in root cause analyses.
Design and execute effective trending methodologies for raw materials including statistical process control and metrics and support enhanced characterization and data analysis, e.g., latent variable statistical models.
Interpret and implement industry and regulatory guidance for raw materials, e.g. ICH, FDA, and EMA. Ensure safety and compliance with GMP, quality, and scientific principles. Ability to author certain raw material sections of regulatory documents for global filing of Janssen biologic drugs.

Qualifications

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 in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 9 years of experience OR Ph.D. with 3-5 years of industry experience in analytical field is required.

Understanding or experience with pharmaceutical development for biologics, GMP guidelines, analytical method development, validation and technical transfer of methods is preferred.
Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is preferred

Proficiency in analytical development, optimization, and validation knowledge of diverse methods such as LC, GC-FID, GC-MS, GPC, Ion Exchange, Affinity chromatography, wet chemistry techniques, ICP/MS-OES, ELISA, and SDS-PAGE are preferred.
Proven proficiency in development of analytical methods and ability to multi-task and communicate effectively is strongly preferred
Self-motivation, resourcefulness, strong written and verbal communication skills, and project management experience with global/diverse teams are crucial.
Proficiency with project/data management tools (e.g., MS Project) is preferred.