Senior Analytical Scientist – Synthetic API Full-time

Senior Analytical Scientist – API

Are you an experienced analytical scientist within synthetic API's and enjoy collaboration with Contract Manufacturing Organisations (CMOs) worldwide to bring new products to market? Join us on an exciting journey as we pursue an ambitious strategy for synthetic chemical API Ingredients. If this sounds like you, we look forward to welcoming you to our 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. Our department is responsible for ensuring that a robust and efficient analytical program is implemented at the CMO's and maintained throughout the life-cycle. Moreover we are also taking lead on regulatory submissions. Your key responsibilities will include:

• Act as Scientific lead and provide expertise to CMOs or to other stakeholders
• Lead analytical activities (incl. submission) from post phase 3 clinical studies throughout commercial life cycle
• Handling technical transferring and implementing 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 SOP's to support our daily work

As we are a developing area, you must be able to set direction and use your previous experience to define ways of working, also when the path is not clear. You will be responsible for taking products to market, whereas you need to have a strong foundation in GMP to bridge between development and commercial aspects and create robust and reliable processes that can support 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 can 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. QC laboratory
• Possess strong knowledge within GMP, ICH guidelines, and pharmaceutical regulatory requirements
• Working with deviations, change request, 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 adaptation, 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 skills at communicating with all types of stakeholders both verbally and in writing, and you are motivated by the opportunity to expand your network within our field.

About the Department

External Analysis & QC is a department currently with teams based in USA and Denmark. We have 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 we offer

At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer 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 employee benefits based on position level, location, functional area and relevant market benchmarks.