Scientist - Analytical Development - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
Small Molecule Method Development (SMMD) is a department of Analytical Development (AD) within the Discovery, Product Development and Supply (DPDS)/ Small Molecule Pharmaceutical Development (SMPD) organization. The department is responsible for:
- Small Molecule Method Development, Method Validation, Method Transfer and support. This includes Active Pharmaceutical Ingredients, Drug Products, Chemical Raw Materials, Starting Materials, Intermediates and In-Process Controls from early development through the lifecycle for commercial products.
- Analytical support for all regulatory filings, Inspections and investigations
- Focused analytical base business support for the Small Molecule R&D and Manufacturing product portfolio
- Development and implementation of Process Analytical Technology (PAT) / New Innovative Analytical Technology Platforms for Small Molecules
- Analytical Centers of Excellence in Cleaning Validation
In the SMMD department in Beerse, Belgium, there is currently a full-time opening for a (m/f) Scientist
Job description
- Responsible for the planning, coordination and execution of the analytical experimental work (method development, -validation, -transfer) in support of the relevant quality attributes of the active pharmaceutical ingredients (API’s), raw materials/intermediate products and Drug Product. The main part of this experimental work is focusing on analytical methods for assay/purity, content uniformity, ID, moisture and solvents.
- Knowledge regarding the analytical control strategy for Oligonucleotide and Oligopeptide projects besides Small Molecules is considered as a surplus.
- Independently manages multiple assigned projects: establishes priorities, checkpoints, and time frames for the analytical experimental work to be done by SMMD in line with the project- and team objectives/deliverables.
- Works closely within the own team (peers and functional managers), within the AD organization (project leads, clinical release and stability team) as well with our development and commercial partners (API SM Development, DP SM development, Janssen Supply Chain quality control labs)
- Advises SMMD management of technical requirements needed to accomplish the tasks.
- Informs SMMD management and stakeholders about potential technical/scientific challenges and risks, prioritization or resources conflicts and makes suggestions to resolve or mitigate these issues/challenges and risks.
- Advises SMMD management on opportunities to improve the support and efficiency of the analytical method development/validation/transfer activities linked to the analytical support for API’s, its raw materials/intermediate products and the Drug Products associated with the portfolio.
- Reviews the scientific data and assists the SMMD scientists to summarize/interpret the data and to draw conclusions.
- Acts as a scientific coach for junior staff members.
- Ensures that applicable guidelines, established operating procedures and safety regulations adhering to company work standards are being followed.
- Report results to teams and management.
- Ensure high scientific quality standards for experiments and take on responsibility for these experiments.
- Author and review technical reports, protocols and standard operating procedures.
- Maintain knowledge of Good Manufacturing Practices (GMP) and ICH Guidelines related to the field of oligonucleotides/oligopeptides.
- Comply with regulatory, GMP and safety rules
- Work in a multidisciplinary team
Qualifications
Education & experience
- You hold a Doctorate (Ph.D.) in Analytical (Bio)Chemistry, Bio-Engineering or a Master Degree in a related science with preferably more than 4 years of relevant experience
- In-depth technical knowledge and experience for developing/validating and transferring analytical methods in support of Small Molecules (preferably in a GMP setting) with major focus on techniques as Liquid Chromatography and Mass Spectrometry.
- Knowledge and/or experience with oligonucleotide/oligopeptide synthesis processes and drug formulation processes is beneficial.
Competencies
- You can work independently, though you are also an excellent team player
- Project management
- Prudent Risk-taking
- Self-Awareness & Adaptability
- Ensure high scientific quality standards for experiments and take on responsibility for these experiments.
- Efficient, flexible and dynamic
- Innovative solutions/technical skills – being problem solving
- Customer focus and results and performance driven
- Sense of Urgency
- Excellent communication skills (verbally and written)
- Excellent English oral and written proficiency.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our
day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2005831551W