Development Manager

Orion Pharma; Turku; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Career development opportunities

Meaningful role

Job summary

Orion Pharma in Finland is seeking an experienced Development Manager in Analytics to coordinate analytical activities across product maintenance and pharmaceutical development projects. You will collaborate with Quality Control, Regulatory Affairs, and external service providers while contributing to stability studies and method lifecycle management.

The role is non-laboratory-based, joining a hybrid work model with permanent status, located at Espoo or Turku plants, and involving

Qualifications

• University degree in Chemistry or a relevant field.
• Good understanding of chromatographic techniques, particularly HPLC.
• Experience working in a GMP-regulated environment.
• Experience with pharmaceutical finished products.
• Fluent Finnish and English.

Responsibilities

• Acting as an analytical expert in product maintenance and pharmaceutical development projects
• Planning and coordinating analytical activities supporting lifecycle management of commercial products
• Supporting variation, marketing authorization maintenance and other regulatory projects
• Writing, reviewing and approving analytical documentation and study reports
• Managing analytical investigations and troubleshooting activities related to finished products
• Coordinating activities performed by external service providers
• Participating in cross-functional project teams and collaborating with stakeholders across the organization
• Managing stability studies, analytical method lifecycle management, method transfers and validation activities
• Contributing to continuous improvement of processes, ways of working and documentation practices

Skills

HPLC

GMP experience

Analytical thinking

Communication

Multitasking

Education

University degree in Chemistry or related field

Tools

SAP

Job description

Job Description

As a

Job DescriptionAs a Development Manager in Analytics Department of Commercial Product Development and Lifecycle Management organization, you will work as an analytical expert both in product maintenance and in pharmaceutical development projects. In this role, you will be responsible for planning and coordinating analytical activities related to pharmaceutical finished products throughout their lifecycle. You will contribute to product improvement projects, marketing authorization maintenance and regulatory actions, analytical investigations, stability studies and problem-solving. The position is non-laboratory based, and the department does not have its own laboratory facilities.

You will work closely with stakeholders across the organization, including Quality Control, Quality Assurance, Regulatory Affairs, Method Development Center, Manufacturing and external service providers.

You can be located either at Orion’s Espoo or Turku plant. You can work part of the time remotely according to our hybrid model. Position is permanent.

Responsibilities

• Acting as an analytical expert in product maintenance and pharmaceutical development projects
• Planning and coordinating analytical activities supporting lifecycle management of commercial products
• Supporting variation, marketing authorization maintenance and other regulatory projects
• Writing, reviewing and approving analytical documentation and study reports
• Managing analytical investigations and troubleshooting activities related to finished products
• Coordinating activities performed by external service providers
• Participating in cross-functional project teams and collaborating with stakeholders across the organization
• Managing stability studies, analytical method lifecycle management, method transfers and validation activities
• Contributing to continuous improvement of processes, ways of working and documentation practices

What You Can Expect From Us

• A meaningful role in the development and maintenance of pharmaceutical products
• A broad and diverse portfolio of analytical and development-related responsibilities
• The opportunity to work with skilled experts across multiple functions
• A supportive team and collaborative work environment
• Opportunities for professional growth and long-term career development

At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ .

What are we looking for? We are looking for a motivated and collaborative analytical expert who enjoys solving technical challenges and working in a dynamic project environment.

To Succeed In This Role, You Have

• A university degree in Chemistry or another relevant field
• Good understanding of chromatographic techniques, particularly HPLC, and other analytical methods used in pharmaceutical analysis
• Experience working in a GMP-regulated environment
• Experience with pharmaceutical finished products
• Good understanding of quality requirements and analytical problem-solving
• Ability to manage multiple tasks and priorities simultaneously and routine operational responsibilities
• Strong analytical thinking and attention to detail
• Good communication and collaboration skills
• Fluent Finnish and English language skills

The Following Will Be Considered An Advantage

• Experience with regulatory documentation, marketing authorization and variation applications
• Experience with analytical method validation, transfer or lifecycle management
• Experience working with external laboratories or contract research organizations
• Experience in pharmaceutical product analytics and product lifecycle management
• Familiarity with SAP and other pharmaceutical quality systems

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.

Your new team Orion's Global Operations covers the entire pharmaceutical manufacturing process, from sourcing of raw materials to the manufacture of products, packaging and delivery to customers. We are also responsible for the industrialization of new products and product life cycle management.

In Global Operations we have approximately 1,600 professionals working in Production, our external supplier network (Externally Sourced Operations) and Fermion Oy (API manufacturing and marketing). In addition, the organization includes Supply Chain & Procurement, Technical Operations, Facility Management, EHS (Environment, Health and Safety), CPD&LCM (Commercial Product Development & Product lifecycle management) and Operations Development.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company - a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.