DP formulation coordinator- Stockholm

Job description
Here’s your chance to join an innovative and expanding team in the development. We are looking for a Drug Product and Formulation Coordinator dedicated to ensuring access to biologics for undeserved patient populations globally. Be part of a journey to create a success story in Swedish biopharmaceutical development.
As part of the Downstream Process Development team, you will coordinate drug process and formulation development. This role involves managing external suppliers and coordinating both internal and external activities during the development and transfer of manufacturing processes from R&D to commercial scale.
Expect dynamic day-to-day interactions with our R&D team to support project progress. You may act as a person-in-plant during studies or manufacturing campaigns. Working closely with R&D, Supply Chain, QA, and Regulatory Affairs teams, you will coordinate drug product and formulation development for future commercial manufacturing processes, reporting to the Head of DSP.


This is a consultant assigment. As a consultant with Randstad Life Sciences, we are your employer, but your daily workplace will be with one of our clients. Your consultant manager is always close at hand, both during and between assignments, to help you develop your career in the direction of your dreams. As our consultant, you will receive a competitive salary, benefits, and collectively agreed terms. We are attentive to your preferences regarding assignments and tasks, and with our broad client portfolio in Mälardalen, we will together tailor your continued career according to your skills, experience, and ambitions. At Randstad Life Sciences, we offer opportunities for professional development and/or additional leave after you have been with us for a while. You will be part of a larger consulting team within Life Sciences, allowing you to expand your network and gain valuable experience from various workplaces.


Submit your application as soon as possible. Selection and interviews will be conducted continuously, so send in your application today. We do not accept applications via email.


We look forward to receiving your application!

Responsibilities
Lead and coordinate project activities focusing on drug product and formulation development.
Define drug product and formulation requirements and processes in combination with delivery systems.
Participate in sourcing projects for drug product development services and delivery systems.
Write technical reports to document development activities and facilitate tech transfer.
Write and review process descriptions and batch records.
Coordinate formulation and drug product process tech transfer in collaboration with Supply Chain.
Provide technical support including document review, process data trending, and review of technical investigations and validations.
Educate colleagues and stay updated in the field of drug product and formulation development.

You as a person are:
You are proactive and independent, driving activities while being a supportive team member in a fast-paced environment.
You embrace flexibility, creativity, and collaboration, ready to tackle problems with innovative solutions.
You have a positive, can-do attitude, viewing challenges as opportunities for growth.
You value teamwork, transparency, and honesty, contributing to a supportive and united work environment.


Qualifications
University degree in Life Sciences with at least 10 years of experience in the pharma industry.
Extensive project management experience, including coordinating external activities and managing contractor/CMO/CDMO relationships.
Experience and knowledge in drug product and formulation development.
Proficiency in several of the following areas: biopharmaceuticals, biologics manufacturing requirements, drug product process development, formulation development, process tech transfer, process validation, project budgets.
Additional experience with drug substance and drug product manufacturing processes is meriting.
Several years of experience in working according to GMP requirements.
Proficient in English.


About the company

Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.