Location: Høje-Taastrup
Are you an experienced analytical scientist within synthetic APIs and do you enjoy collaborating with Contract Manufacturing Organisations (CMOs) worldwide to bring new products to market? Join Novo Nordisk A/S on an exciting journey as Novo Nordisk A/S pursues an ambitious strategy for synthetic chemical API Ingredients.
If this sounds like you, Novo Nordisk A/S looks forward to welcoming you to Novo Nordisk A/S' department for External Analysis in Synthetic API and Contract manufacturing. Submit your application today!
The Position
As a Senior Analytical Scientist - API, your primary role is providing scientific and GMP expertise to CMOs. Novo Nordisk A/S' department is responsible for ensuring that a robust and efficient analytical program is implemented at the CMOs and maintained throughout the lifecycle.
Moreover, Novo Nordisk A/S also takes the lead on regulatory submissions.
Your key responsibilities will include:
- Act as scientific lead and provide expertise to CMOs or other stakeholders
- Lead analytical activities (incl. submission) from post-phase 3 clinical studies throughout the commercial lifecycle
- Handle technical transfer and implementation of analytical methods to/from collaborative partners
- Authoring and editing SOPs, reviewing protocols, reports, tech transfer plans, and other documentation
- Build and optimize internal processes and SOPs to support Novo Nordisk A/S' daily work
As Novo Nordisk A/S is a developing area, you must be able to set direction and use your previous experience to define ways of working, even when the path is not clear. You will be responsible for bringing products to market, and you will need to have a strong foundation in GMP to bridge between development and commercial aspects and create robust and reliable processes that can support the commercialization of the products.
You will be part of a team of subject matter experts, fostering an open, positive, and collaborative atmosphere for discussing ideas, problems, and solutions. Given that many CMOs are internationally based, the position may involve some travel, and meetings outside of normal working hours may occur.
Qualifications
To succeed in this role, you:
- Hold a minimum of a Master’s degree in Pharmacy, Chemistry, Biochemistry, Chemical Engineering, or other similar scientific disciplines
- Have a minimum of 5 years of experience in a similar position within the pharmaceutical sector
- Have hands-on experience working in a GMP-regulated environment, e.g., a QC laboratory
- Possess strong knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements
- Working with deviations, change requests, out-of-specifications, and method validation is part of your experience
- Showcase full professional proficiency in both spoken and written English
Knowledge of late-phase (phase 3 and ongoing) pharmaceutical development projects and previous experience working with chemical synthesis (e.g., small molecules or peptides) is an advantage.
As a person, you thrive on a high level of flexibility and adaptability, enabling you to excel in a role where the quality of your work is paramount. You have “a firm hand” when it comes to science and possess good communication skills with all types of stakeholders, both verbally and in writing, and you are motivated by the opportunity to expand your network within Novo Nordisk A/S' field.
About the Department
External Analysis & QC is a department with teams currently based in the USA and Denmark. Novo Nordisk A/S has a growing pipeline, many of which are based on new technology platforms coming through internal development projects or acquisitions.
You will join a diverse team of Analytical Project Managers, Senior Analytical Professionals & Analytical Professionals.
What Novo Nordisk A/S offers
At Novo Nordisk A/S, you’ll join a global healthcare company with a unique culture and strong results. Novo Nordisk A/S offers continuous learning, career development, and benefits tailored to your life and career stage.
Salary: For this role, the annual base salary ranges from 651,000.00 to 956,900.00 DKK, corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.
Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other benefits.
