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.
Janssen Pharmaceutica NV is recruiting for a Large Molecule Drug Substance/Drug Product Process SME, located preferably in Titusville (New Jersey), Malvern (Pennsylvania), Leiden (The Netherlands), Cork (Ireland), Schaffhausen (Switzerland) or Beerse (Belgium).
The process SME drives the multi-functional technical scientific review of each development program at predefined time points of the development process with the objective to improve product and process mechanistic knowledge, to drive robust product and process with multivariate-based and statistically valid ranges and specifications, to ensure advanced and proactive process control, to lean out scale-up and tech transfer and to secure post-approval regulatory flexibility. The SME is exposed to all programs of the Development Portfolio of the Large Molecule Platform, including Vaccines, Cell & Gene Therapy products, and as such has the capability to influence and tune the product and process under development to maximally meet JSC’s expectations. The SME is encouraged to take the findings from all reviews, suggest development process optimizations and incorporate those in existing development methodologies.
Key Responsibilities:- Plan and schedule technical scientific reviews according to agreed upon time points in the development process and in line with the evolution of every specific development program
- Carefully prepare the review by studying the available development information and assessing completeness and consistency of the information
- Evaluate thoroughly the BPAL (Best Product & Process at Launch) information provided by the team and prepare a technical scientific assessment of the team-proposed BPAL ambitions and subsequent execution of those ambitions
- Lead and complete the review in the presence of the team with proactive focus on
- level of mechanistic knowledge
- understanding of analytical method performance
- multivariate sensitivity of product to raw material and process variation
- robust raw material, process and product based on multivariate and statistically valid ranges and specifications at release and on stability
- advanced process control capable of anticipating on (intermediate) product shifts, trends or failures
- model-based scale-up and tech transfer
- advanced approaches to QC (e.g. real-time release testing)
- model-based correlation between in process measurements and CQAs resulting in post-approval regulatory flexibility
- Document concisely and accurately outcomes and conclusions of the review and share with team and council members as team-independent project assessment recommendations to the council stage gate meeting
- Periodically list the lessons learned from all past reviews, categorize them in terms of root causes and propose upgrades for development methodologies addressing those root causes
- Irrespective of review lessons learned, perform regular reviews of development methodologies and suggest methodology optimizations
Qualifications
Education:
- Master (required)/PhD (preferred) in (Bio)pharmaceutical Sciences, Biochemistry, Biotechnological Engineering or equivalent.
- Any specialization in process or process control engineering is preferred.
Required:
- Proven experience in the design, development, transfer and optimization of biotechnological processes such as the manufacturing of Mab’s and/or vaccines
- Deep knowledge regarding the development, scale up and transfer of upstream and downstream biotechnological processes
- Strong expertise regarding the characterization, in-line and off-line testing of properties of intermediate and finished drug substances and drug products
- Substantial expertise regarding the design, execution and interpretation of experiments towards a most effective and efficient development, scale up and transfer
- Extended knowledge on what constitutes a robust drug substance/drug product and its respective processes, how sensitivities to raw material and process variations can be explored and how those variations can be minimized
- Profound knowledge and expertise regarding data analytics, statistics and modeling
- Knowledge of Quality-by-Design principles and concepts
- Knowledge regarding coordinated E2E development of a drug product incl. tuning relevant drug substance properties towards the specific needs of the drug product
- Knowledge regarding biopharmaceutical behaviour of drug product and related desired drug substance properties
- Knowledge and expertise regarding analytical method development, transfer and validation for release and stability testing purposes and the impact of method performance on the evaluation of test results
- Knowledge and expertise regarding basic quality & compliance and GMP requirements and guidelines
- Knowledge and expertise regarding regulatory filing requirements, dossier submission and approval processes
- Excellent oral and written communication skills, proficiency in English both verbal and in writing and well-developed intercultural social skills are required; additional language skills are an advantage
- Proficiency in planning, proactivity, self-motivation, and the ability to work independently are required
- Excellent leadership and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams
- Deep knowledge of continuous improvement tools, lean manufacturing and six-sigma is preferred; Six Sigma black belt certification is a plus
- Ability to make timely decisions and operate efficiently in times of ambiguity
- Demonstrated knowledge and expertise in bridging technical and business fields, evaluating and resolving risks is required
- Being meticulous, highly organized and able to lead multiple tasks, handle timelines and deliver quality job is require
- Requires up to 35% domestic and international travel
United States-Pennsylvania-Malvern-
Other Locations
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-Florida-Titusville, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Engineering
Requisition ID
2206044853W