Role Overview:
As a Senior Analytical Scientist, you will play a leading role in the development, optimization, and characterization of analytical methods for plasmid DNA (pDNA) and proteins. You will be responsible for designing and executing robust analytical strategies that support both internal research and GMP manufacturing activities. This includes method development, qualification, and validation for pDNA and protein characterization, as well as troubleshooting and continuous improvement of analytical workflows.
Key analytical instruments you will work with include HPLC, SEC and IEX, CGE (Capillary Gel Electrophoresis), SoloVPE, and viscosimeters. Some knowledge of MS and DLS will also be beneficial. You will ensure that analytical methods are fit-for-purpose and provide scientific oversight for external method development and testing performed at CROs and CDMOs.
During GMP manufacturing of drug substance and drug product at CDMOs, you will hold analytical responsibility for the control strategy and associated analytical methods. This encompasses establishing and managing analytical test programs in collaboration with CDMOs, covering in-process controls, release testing, characterization, and stability studies. You will define and justify specifications, monitor external testing results, handle out-of-specifications, deviations, changes, and CAPAs related to analytical methods, and perform trending and evaluations. The role also includes responsibility for regulatory documentation and interactions related to the control strategy and analytical methods.
Key Responsibilities:
- Lead the development, optimization, and characterization of analytical methods for pDNA and proteins.
- Plan, execute, and report analytical testing of pDNA and proteins; maintain analytical instruments.
- Oversee external method development at CROs and CDMOs, validation, and testing, ensuring scientific rigor and regulatory compliance.
- Take analytical responsibility for control strategies, in-process testing, release testing, and stability programs during GMP manufacturing.
- Analyze data through trending and evaluation to support product quality and process understanding.
- Participate in project teams and work cross-functionally with internal and external stakeholders.
- Contribute to documentation such as regulatory submissions (CTA/IND), scientific advice and if relevant, publications and patent filings.
- Write and revise SOPs and WINs.
Qualifications and Experience:
- MSc or PhD in chemistry, biochemistry, biotechnology, or a related scientific discipline.
- Minimum 5 years of relevant professional experience.
- Strong scientific background with demonstrated experience in analytical method development, validation, and testing
- Thorough understanding of GMP principles and regulations.
Personal Traits:
We are seeking an organized and proactive individual with excellent collaborative skills. The ideal candidate takes ownership of their responsibilities and drives analytical activities forward. Strong interpersonal and communication skills are important, as the role involves working across functions internally and with external partners and vendors.
Who are we looking for?
When hiring new employees, we look for people who are inspired by the Nykode technology and our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for the people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. Life at Nykode is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful, and we care. We care about the patients, and we care about each other.
The application process
Due date: 9 Nov.We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: HR@nykode.com
