Senior Analytical Scientist - Synthetic API

Novo Nordisk; Taastrup; Presencial; DKK 651 000 - 957 000; Tempo integral

Resumo da oferta

Novo Nordisk in Denmark is seeking a Senior Analytical Scientist to provide GMP-driven scientific leadership for analytical activities with CMOs worldwide, spanning late-stage development through commercial supply, based in Høje-Taastrup.

You will transfer methods, author and review analytical documentation, collaborate with internal stakeholders and external partners, and drive quality improvements while travelling internationally (<14 days per year) as needed.

Qualificações

• Master’s degree or higher in Pharmacy, Chemistry, Biochemistry, Chemical Engineering or related discipline.
• Minimum five years of relevant pharmaceutical analytical experience.
• GMP-regulated environment experience and knowledge of ICH guidelines.

Responsabilidades

• Act as scientific lead for analytical activities with CMOs and internal stakeholders.
• Lead analytical contributions to regulatory submissions from late-stage development through the commercial lifecycle.
• Transfer and implement analytical methods between Novo Nordisk and external partners.
• Author and review analytical documentation including SOPs, protocols, reports and method transfer plans.
• Develop and improve internal processes and SOPs to support consistent and efficient ways of working.

Conhecimentos

English proficiency

Formação académica

Master’s degree or higher in Pharmacy, Chemistry, Biochemistry, Chemical Engineering or related scientific discipline

Descrição da oferta de emprego

Department: Synthetic Analytical MSAT department

Location: Høje-Taastrup

Your impact begins here.

Are you an experienced analytical scientist who wants to help bring new medicines to market? Join Novo and take scientific ownership of analytical activities for synthetic APIs, working with Contract Manufacturing Organisations (CMOs) worldwide.

You will use your analytical and GMP expertise to support products from late-stage development through commercial supply. You will also help shape the processes and ways of working in our growing Synthetic Analytical MSAT department.

What You’ll Bring

• A master’s degree or higher in Pharmacy, Chemistry, Biochemistry, Chemical Engineering or a related scientific discipline.
• At least five years of relevant experience in pharmaceutical analytical science.
• Practical experience working in a GMP-regulated environment, such as a QC laboratory.
• Strong knowledge of GMP, relevant ICH guidelines and pharmaceutical regulatory requirements.
• Experience with deviations, change control, out-of-specification investigations and analytical method validation.
• Full professional proficiency in written and spoken English.

You bring sound scientific judgement and communicate complex analytical topics clearly to different stakeholders. You enjoy working collaboratively, take ownership of your responsibilities and maintain a strong focus on quality. You are comfortable setting direction when processes are still developing and building effective relationships with colleagues and external partners.

Useful, But Not Essential

• Experience with late-stage pharmaceutical development and synthetic APIs, including small molecules or peptides.

What You’ll Do

As a Senior Analytical Scientist, you will provide scientific and GMP expertise to CMOs and internal stakeholders. You will help ensure that robust and efficient analytical methods and programmes are established at our manufacturing partners and maintained throughout the product lifecycle. You will also lead analytical contributions to regulatory submissions.

• Act as the scientific lead for analytical activities, providing expertise to CMOs and internal stakeholders.
• Lead analytical activities and contributions to regulatory submissions from late-stage development through the commercial lifecycle.
• Lead the transfer and implementation of analytical methods between Novo and external partners.
• Author and review analytical documentation, including SOPs, protocols, reports and method transfer plans.
• Develop and improve internal processes and SOPs to support consistent and efficient ways of working.

Who You’ll Work With

You will work alongside analytical specialists and project managers in a team that encourages open discussion, knowledge sharing and collaborative problem-solving. As our manufacturing partners are based worldwide, the role includes some international travel (<14 days a year) and occasional meetings across time zones.

What You Can Expect Here

In this growing area, you will have the opportunity to shape analytical processes and ways of working. You will use your experience and scientific judgement to set direction, resolve analytical challenges and support the transition from development to commercial supply. A strong understanding of GMP will help you establish robust processes that support product approval and reliable commercial manufacturing.

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.

Learn more about our Reward Philosophy here.

The application deadline is 15th of October.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.