Senior Industrial Microbiology Specialist

PolyPeptide is now looking for a Senior Industrial Microbiology Specialist to join our Production Specialist Team. In this newly created role, you will combine microbiology, GMP and industrial processes to strengthen our production and manage microbiological risks. Would you like to help strengthen microbiological control at a world-leading peptide manufacturer? Apply today!

About PolyPeptide

PolyPeptide Group AG and its consolidated subsidiaries ("PolyPeptide") are a specialised contract manufacturer and development organisation (CDMO) for active pharmaceutical ingredients based on peptides and oligonucleotides. By supporting our customers, primarily in the pharmaceutical and biotechnology industries, the company contributes to the health of millions of patients around the world. PolyPeptide operates in a rapidly growing market and offers products and services from the preclinical phase to commercial stages. Our broad portfolio reflects the opportunities in drug therapies across various areas, with significant exposure to metabolic diseases, including GLP-1. With roots going back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the USA and India. PolyPeptide's shares (SIX: PPGN) are listed on the SIX Swiss Exchange.

United by Purpose

At PolyPeptide we are proud of our vital products and committed to our shared goal - to create active substances for medicines that make a difference to people's lives and health. Our culture is shaped by our core values of Trust, Innovation and Excellence, which show in our closely knit teams, high quality and commitment; to one another, to our customers and to millions of patients around the world. We are a company with rapid growth and high ambitions, where both employees and the business develop together.

About the role

As Senior Industrial Microbiology Specialist, you will play a central role in developing and strengthening our work in industrial microbiology within GMP-regulated peptide manufacturing. You combine microbiological expertise with an understanding of manufacturing processes, equipment, cleaning and hygienic design to identify, assess and prevent microbiological risks.

This is a newly created role, which gives you a great opportunity to shape the assignment and develop how we work with microbiological questions in the business. You identify needs, establish ways of working and drive issues within your area of expertise.

You work close to operations and cross-functionally together with Manufacturing, Engineering, Validation and Quality. Your expertise becomes important throughout the lifecycle, from design and change of equipment and facilities to cleaning strategies, risk assessments, investigations and improvement work.

As a senior specialist in our Production Specialist Team, you will have the opportunity to influence both operational work and the long-term development of the area.

Your main responsibilities:

• Act as Subject Matter Expert (SME) in industrial microbiology and drive the development of the area within the business.

• Lead microbiological risk assessments and ensure that risks linked to processes, equipment, facilities and cleaning are identified, assessed and managed.

• Drive and contribute microbiological competence in deviation investigations, root cause analyses, CAPA work, Change Requests and cross-functional task forces.

• Ensure that microbiological aspects and hygienic design principles are integrated in the design, change and implementation of equipment and facilities.

• Act as microbiological SME in investment projects and contribute expertise from the early design phase through to implementation.

• Develop and drive cleaning strategies and cleaning methodology from a microbiological perspective, including Clean Hold Time and the selection and evaluation of cleaning methods and cleaning agents.

• Analyse and evaluate microbiological results and relevant process data as a basis for risk-based decisions and improvement measures.

• Develop ways of working and knowledge in industrial microbiology and contribute to strengthening competence within the organisation.

• Ensure relevant GMP documentation within the area of expertise and represent the area at customer audits and regulatory inspections.

We are looking for you who have:

• Academic education in microbiology, industrial biotechnology, bioprocess engineering, chemical engineering, food technology or another relevant field.

• Extensive experience from the pharmaceutical industry, biotech, medical technology, the food industry or another GMP-regulated manufacturing industry.

• Deep knowledge of industrial microbiology and a good understanding of how microbiological risks are affected by manufacturing processes, equipment, cleaning and the production environment.

• Experience of independently driving complex microbiological questions, risk assessments and investigations in an industrial environment.

• A good understanding of hygienic design and how the design of equipment and facilities affects microbiological risks.

• Experience of quality work within GMP, for example deviation management, CAPA and Change Control.

• Experience of working cross-functionally and the ability to turn specialist knowledge into practical, risk-based and sustainable solutions.

• Very good knowledge of Swedish and English, both spoken and written.

Meriting

• Experience of Clean Hold Time (CHT), cleaning validation and cleaning strategies.

• Experience of qualification of equipment and facilities.

Personal qualities

As the role is new, we are looking for you who are confident in your specialist competence and motivated by taking responsibility for building up and developing an area. You identify the needs of the business, set direction and independently drive the work from analysis and prioritisation to an implemented solution.

You work analytically and in a structured way and understand how microbiology, processes, equipment, quality and production affect each other. With a pragmatic and solution-oriented approach, you turn your specialist knowledge into sustainable solutions that work in a complex production environment.

The role has many points of contact and you need to be able to build trust in your expertise, collaborate effectively across functional boundaries and challenge existing solutions when needed. You willingly share your knowledge and help develop both ways of working and colleagues.

The right challenge for you?

PolyPeptide offers a dynamic working environment during an exciting growth journey, where you get the chance to both challenge yourself and be part of shaping things. With us you not only get the opportunity to make a real difference but also be part of a great team where we have fun together. With favourable reduced working hours, leave on bridge days and a strong focus on health and wellness activities, we create conditions for wellbeing both at and outside of work.

Welcome with your application! The closing date for applications is 25 November, but rolling selection is applied, which means we may progress in the process before the closing date.

If you have questions about the position, you are welcome to contact Catharina Ljungqvist (Manager Production Specialist Team) by email [contact details removed]. Union information is available from the chairpersons of Akademikerföreningen and Unionen, who can be reached by phone at [contact details removed].