Senior Scientist - Oligonucleotides/Oligopeptides expert
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- 1905731196W Requisition #
- 📅
- Jul 18, 2019 Post Date
Department Description
Small Molecule Method Development is a department within Discovery, Product Development and Supply (DPDS)/ Small Molecule Pharmaceutical Development (SMPD). 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 (CTA/IND, NDA/MAA, Post Approval Submissions), Inspections and investigations
- Focused analytical base business support for the Small Molecule (SM) 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)
Senior Scientist - Oligonucleotides/Oligopeptides expert
Job description
- You act as an expert for the Analytical Development organization regarding the analytical control strategy for Oligonucleotide and Oligopeptide projects
- You are responsible for the planning, coordination and execution of the analytical experimental work (method development, validation, transfer) the main part of this experimental work focusing on analytical methods for assay/purity, content uniformity, ID, moisture and solvents
- You independently lead multiple assigned projects: establishes priorities, checkpoints, and time frames in line with the project- and team objectives/deliverables
- You will collaborate closely with colleagues from analytical, API and Drug product development
- You advise and inform management and stakeholders of technical requirements, about potential scientific challenges and risks, prioritization or resources conflicts and makes suggestions to resolve or mitigate these
- You initiate ideas to improve the support and efficiency of the analytical method development/validation/transfer activities for the oligonucleotide and oligopeptide portfolio
- You act as a scientific coach for junior staff members
- You ensure that applicable guidelines, established operating procedures and safety regulations adhering to company work standards are being followed
- You author and review technical reports, protocols and standard operating procedures
- You maintain knowledge of Good Manufacturing Practices (GMP) and ICH Guidelines related to the field of oligonucleotides/oligopeptides
Education & experience
- You hold a Doctorate (Ph.D.) in Analytical (Bio)Chemistry, Bio-Engineering or a related science with preferably more than 5 years of relevant experience
- In-depth technical knowledge and experience for developing/validating and transferring analytical methods in support of Oligonucleotides and Oligopeptides with major focus on techniques as Liquid Chromatography, Mass Spectrometry, Ion Pairing is required. Knowledge of gas chromatography is a surplus
- Knowledge and/or experience with oligonucleotide/oligopeptide synthesis processes and drug formulation processes is highly preferred.
Competencies
- You can work independently, though you are also an excellent collaborator and like to work in a multidisciplinary, inter departmental and cultural divers context
- You can oversee projects in a professional way with respect to deadlines and with a good sense of urgency
- You ensure high scientific quality standards for experiments and take on responsibility for these experiments
- You are a prudent risk-taker, who thinks of innovative and creative solutions
- You are efficient, flexible and dynamic and can easily adapt yourself to different situations
- You are customer focused and results and performance driven
- You have excellent communication skills (verbally and written) with excellent English proficiency
- You are self-aware and willing to look for opportunities to grow and develop
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.