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QA Assistant, GS-5, QAC

This position is embedded in the Quality Assurance Centre (QAC), where teams have coreresponsibilities around quality assurance and quality control of supply processes and the productswe procure and deliver.

The incumbent will beresponsible for assisting the Quality Assurance Specialist (non-pharma) in the management of all aspects of Pre-Delivery Inspection (PDI) arrangements for non-pharma items from initial request tofinal invoice certification.

Global Regulatory Specialist, Plant Health (temporary position)

As Regulatory Affairs Specialist you will be part of the Global Regulatory Affairs team, with around 18 team members across the globe. You will work closely with stakeholders in the Plant Health industry and support the execution on regulatory strategies globally.

You will interact with cross-functional product and project groups and maintain close interaction with stakeholders in biotechnology, other parts of R&D, sales, marketing and with strategic customers and authorities.

Project Coordinator

Do you have experience managing projects anchored to a GMP facility? Are you eager to contribute to the development of a newly established project team in a production environment?

As a Project Coordinator, you will participate in the successful planning and completion of projects related to the Drug Substance Manufacturing Processes. You will coordinate and follow up on a number of tracks that links to various projects.

Experienced Scientist for validating QC methods in Novonesis

Do you want to work in an environment where great collaboration is valued as highly as scientific excellence?

Working as Scientist in our team, you will be responsible for validating and optimizing analytical methods for Human Health products in our QC labs. You will work closely with other scientists and laboratory technicians to plan and implement efficient microbiological methods.

Clinical Supply IRT/RTSM Specialist

Come help us deliver high-quality clinical trial supply to trials all over the world

We are looking for an IRT/RTSM specialist to help us ensure timely setup of IRT/RTSM systems to support the delivery of trial supply for Ferring clinical programs globally.

In this role you are expected to not only collaborate closely with cross-functional teams but also contribute to a knowledge-sharing mindset and promote a collaborative and innovative work environment. You must have a flair for respectful communication with a range of stakeholders such as Clinical Operations, IT and Quality Assurance.

Operations Data Coordinator for Drug Substance Production

The primary task within the position is to collaborate with various departments (e.g., automation, tech transfer, and manufacturing departments) to collect and translate information required for building efficient production campaigns and daily task schedules.

You will be part of a team with a great sense of humor and a high willingness to support where needed.

Lab Quality Coordinator, GCLP Laboratory

As Documentation Coordinator at the laboratory in Lund at MinervaX, you will play a central role in the establishment of a GCLP laboratory for clinical samples from MinervaX’s prophylactic vaccine targeting Group B Streptococcus (GBS). The GLCP laboratory is established to move into phase III clinical trials. You will be responsible for the writing, coordination, storage, and maintenance of documentation in the whole laboratory area.

This is a unique opportunity to join the journey into building a GLCP compliant laboratory. As this is a new position you can develop this role according to your own ambitions and will be primary person on documentation support.

QA Specialist for Environmental Support

In this role, you will join Bavarian Nordic's QA Organization as a QA Specialist tasked with establishing strong relationships with stakeholders, effectively communicating GxP requirements, and handling crucial Quality Events in the Quality Management System (QMS).

This is in the context of environmental monitoring, aseptic performance, and sterile & low bioburden processes in Drug Substance and Drug Product Production. Additionally, you will contribute to the ongoing improvement of QA processes to elevate overall quality standards.

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

Scientist for Biomarker Assays

Are you eager to use your scientific skills and expertise in preclinical research?

As our new scientist, your tasks will include:

• Coordination and support of biomarker experiments, including supervision of lab technicians.
• Perform data analysis, interpretation, review, and reporting of study results.
• Development of new biochemical- and immunoassays and troubleshooting of existing assays.

Laborant til meget velfungerende peptidkemi laboratorie

Som laborant i vores peptid laboratorie er dit og kollegernes fokus at skabe grundlaget for udvikling af nye lægemidler. Du giver dit vigtige bidrag ved at bruge størstedelen af din tid med at arbejde hands-on i vores state-of-the-art laboratorie.

Du får et meget alsidigt job med ekstraordinært gode muligheder for at lære nyt og udvikle dig. Du kommer til at udføre alle typer af opgaver fra betjening af robotter og forskellige instrumenter til vedligehold og procesoptimering. Du kommer også til at arbejde med databehandling og dokumentation.

Project Manager

Som Project Manager på fabrikken i Hobro vil dit job være opdelt i en projektlederrolle, og en rolle der dækker daglige driftsopgaver.

Du både deltager i og leder selvstændigt større projekter relateret til fabrikkens anlæg og udstyr - fx lokaleombygning, installation af ventilationsanlæg, dokumentation etc. Du skal planlægge og udføre projekter fra start til slut, herunder sikre at tidsplaner og budgetter overholdes, være primær kontakt til myndigheder og eksterne samarbejdspartnere samt udføre, lede og koordinere arbejdet i projekt teamet, så projekterne kommer godt i mål.

Manufacturing Support Documentation Associate

Do you have a flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility?

About the position:

• Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
• Start-up events and support investigations by giving input as procedural SME.
• Support the change process by writing SME assessment to ensure procedural alignment. Perform timely closure of action items to ensure reliable execution of production.
• Continuously improve the department processes and support stakeholder improvement projects.

QA Ext. Manufacturing Specialist

Would you like to work in one of the most interesting, complex, and dynamic areas in Bavarian Nordic? Are you ready to engage, support, and mobilize colleagues in a growing international business environment where we focus on saving lives every day?

As a QA Specialist, you will be responsible for daily support, QA oversight, and GMP guidance to Contract Manufacturing Organizations (CMOs) to ensure that our products are manufactured according to current GMP and our marketing authorizations.

Entrepreneurial Immunologist for Applied Research

Would you like to be part of an exciting journey of generating scientific insights on the health effects of human milk oligosaccharides (HMOs), in addition to further improving infant formulas by bringing them closer to breastmilk?

As our senior immunologist, you will be a key member of the Applied HMOs team by leading our immunology platform. Your primary role will be to ensure a strong platform both by running existing in vitro assays and by establishing novel experimental immunological workflows. You will work closely with our commercial team and will also be involved in meetings with customers.

(Senior) Drug Substance Specialist

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Effective coordination with external partners is a significant aspect of this role.

Ambitious Project Manager to lead key strategic projects

Are you an experienced Project Manager motivated by making a difference? Then look no further – Pharmacosmos is looking for a Project Manager who can solve complex problems across our value chain and deliver impact to the organisation.

As Project Manager, you will become a key member of a small project management team in Pharmacosmos. You will be allocated to important strategic projects that you will lead and drive to completion to the satisfaction of all involved stakeholders using your existing toolbox and competencies for managing projects.

Single Use Systems Professionals

Som Single Use Systems Professional arbejder du med at forbedre Drug Substance produktionens Single Use systemer. Det kan eks. være i forbindelse med en eksisterende item, der ikke fungerer optimalt eller udgår. Du skal derfor søge efter brugbare erstatninger på markedet og kommunikere med leverandørerne og i samarbejde med processpecialisterne designe nye løsninger.

Du bliver en del af en afdeling på i alt 14 kolleger og i dette team er der 7, hvor alderen ligger omkring 30-45 år. Som ny medarbejder bliver du sidemandsoplært og kommer til at følge interne kurser. Du får også en Buddy fra teamet, som du kan støtte dig til.

Manufacturing Supporter

We are looking for a talented Manufacturing Supporter for the Drug Substance Production to join the DS Documentation and Support Department in Hillerød.

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us.

You will be part of a team, consisting of 14 people, with a great sense of humor and a high willingness to support where needed.

Drug Substance CIP Process Supporter

Are you passionate about pharmaceutical CIP? Do you know processes and optimizing production?

As a CIP Process Supporter (Cleaning In Place), you will have a cross-functional role as a link between production, support teams, and technical support.

Your primary focus will involve optimizing our vaccine production and ensuring robust operation in line with CIP requirements and regulations. Additionally, you will play a vital role in daily troubleshooting, collaborating across diverse professional groups to ensure a streamlined production process.