Small Molecule Drug Substance Process SME.

Job content

Janssen Pharmaceutica NV is recruiting for a Small Molecule Drug Substance Process SME, located preferably in Belgium (Beerse-Geel), The Netherlands (Leiden), Ireland (Cork) or Switzerland (Schaffhausen).

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 process SME is exposed to all drug substance development programs of the Development Portfolio of the Small Molecule Platform and as such has the capability to influence and tune the product and process under development to maximally meet JSC’s expectations. The process 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 development team with proactive focus on
• level of mechanistic knowledge of product and process
• 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-vitro and in-vivo behaviour 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 make suggestions as to upgrades of development methodologies addressing those root causes
• Irrespective of review lessons learned, perform regular reviews of development methodologies and make suggestions for methodology optimizations
  
  

Education

Qualifications

• Master (required)/PhD (preferred) in Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent.
• Any specialization in process or process control engineering is preferred.
  
  

Required

Experience and Skills:

• Proven ability in the design, development, transfer and optimization of chemical synthesis and purification processes
• Profound knowledge and expertise regarding drug substance synthesis and process development, scale up and transfer
• Deep knowledge regarding the characterization, in-line and off-line testing of properties of intermediate and finished drug substances
• Hands-on expertise regarding the design, execution and interpretation of experiments towards a most effective and efficient development, scale up and transfer
• Expertise on what constitutes a robust drug substance and process, 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
  
  

Preferred

• Knowledge and expertise 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
• 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
  
  

Other

• 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 multidimensional work environment and collaborate with multi-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 manage multiple tasks, handle timelines and deliver quality job is required
• Requires up to 35% domestic and international travel
  
  

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Ireland-Cork-Cork

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Engineering

Requisition ID

2206044825W