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 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
Master (required) / PhD (preferred) in (Bio)pharmaceutical Sciences, Biochemistry, Biotechnological Engineering or equivalent.
Any specialization in process or process control engineering is preferred.
Experience and Skills :
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