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Ferring Pharmaceuticals A/S, Copenhagen
Would you like to join us in a challenging position as design control specialist? We offer a challenging and exciting job in an international company with great development possibilities, an entrepreneurial and open work environment, where your contributions will be valuable and make a difference.
Your main focus is to work within the device development projects as responsible for the design controls from project initiation until successful design verification, validation and transfer. The position is an opportunity to contribute to the development and documentation aspects of the device part of drug delivery projects including responsibility for the risk management activities, as they move from project initiation to clinical studies, manufacturing, global submission and commercialization.
We are looking for an experienced academic for a new position in Analytical Development, that will provide scientific leadership and coordination for analytical development activities. The department is part of Chemical and Pharmaceutical Research (CPR).
You will be responsible for the analytical development in our global development projects within our highly integrated CMC project organization. You will lead the analytical development for small molecule API’s and IMP for clinical studies, and ensuring sufficient quality of release and stability analyses, and coordination of project activities across the organization.
Unique Human Capital recruiting on behalf of Zealand Pharma in Glostrup
Work with QA in a fast growing and exciting biotech company
As QA Manager – CMC at Zealand Pharma you will become a part of the QA organization overseeing all activities and delivering professional quidance to ensure GxP compliance within all areas. You will be responsible for the overall QA oversight for one of the current phase 3 products applying your knowledge within GMP. The department is headed by the Vice President, Head of QA, and in addition to this position, encompasses 7 QA colleagues. You will be reporting directly to the Vice President, Head of QA.
Your key responsibilities
- Employ GxP QA expertise during the development providing GMP compliance guidance to internal stakeholders
- Influence the compliance of projects and programmes
- Review and approve internal and external documentation
Symphogen A/S, Ballerup
The position as (Senior) Drug Product Scientist offers a unique possibility to take part in the de-velopment of Symphogens antibody products. You will mainly be responsible for drug product process development and manufacture from early stage IMP manufacturing and later stage manufacturing including process validation strategy.
You will collaborate closely with staff from our CMC group and in project teams, to ensure de-velopment progress of Symphogen’s antibody lead candidates.
Tasks and Responsibilities:
- Tech transfer of manufacturing processes to CMOs
- Technical responsible for drug product manufacturing documentation
- Ensure implementation of drug product manufacturing strategy between projects
CMC Biologics A/S, Søborg
Are you passionate about QC in Bioassay? We are looking for one additional scientist! Join a dynamic and international company where everyone is responsible for delivering right on time as one team!
As a Scientist in QC Bioassay, you will be responsible for delivering scientifically sound and cGMP compliant analytical results and documents, plan and complete various projects within deadlines in close collaboration with your colleagues in the group and assist the whole QC department with your professional expertise. You will also have direct contact with external customers and represent QC at regular customer meetings.
The main tasks are as follow:
- Write and review cGMP documents (e.g. test methods, general procedures).
- Review and approve analytical results for cGMP compliance and scientific content.
- Assist in analytical methods transfer from Analytical Development or customers into QC
LEO Pharma, Ballerup
Do you have several years of regulatory experience across the non-clinical and clinical areas, as well as project management of global regulatory submissions?
As Senior Regulatory Project Manager in our Regulatory Affairs Focus Team you will chair cross-departmental RA focus team(s) with members from RA CMC, Labelling, Submission Management and colleagues from our global affiliates. With you as the main driver, the team will prepare, drive and implement regulatory strategies.
Your key responsibilities will be to:
- Lead the regulatory focus team(s) for one of LEO Pharma’s strategic established products
- Prepare Global Regulatory Strategies and ensuring implementation hereof
- Ensure business perspective across functions and high regulatory quality
Unique Human Capital recruiting on behalf of Genmab in Copenhagen
Work in the CMC Regulatory Affairs area within an exciting and fast growing biotech company
Genmab has a robust pipeline of innovative human antibody therapeutics and a number of strategic partnerships are already in place with international blue chip companies.
As CMC Regulatory Affairs Manager, you will be responsible for operational and strategic regulatory input with an emphasis on CMC matters to support worldwide development and commercialization of the Genmab pipeline. You will be part of the operational teams directing and coordinating international regulatory submissions supporting the conduct of clinical trials. Furthermore, you will be supporting marketing authorization submissions to EMA and other regulatory health authorities.
Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life?
PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities.
As a part of our Regulatory Affairs team, your duties will primarily include planning, preparation and submission of regulatory documents. The main responsibilities of the Regulatory Affairs Manager will include:
- Compilation of new authorization applications
- Product launch in the Nordics
- Product maintenance e.g. variations including CMC support
- Publishing activities with eCTD manager
Lundbeck, Nykøbing Sjælland
We are searching for an analytical chemist with expertise in analysis of small molecules to join Process Chemistry Analytics located at the Lundbeck production site in Lumsås near Nykøbing Sj.
As analytical chemist in PCA you will join a group of one academic and three experienced technicians. The job involves analytical development for our new chemical entries and support to our chemical production e.g. by in process controls, release analysis of starting materials, intermediates and raw materials.
You will also contribute to other tasks such as qualification of equipment, writing Standard Operating Procedures and analytical procedures, as well as development and maintenance of other systems Qualifications
LEO Pharma, Ballerup
As Principal Regulatory Specialist your overall focus is to contribute to bringing products to the market by facilitating smooth approvals of Marketing Authorisation Applications. You will unfold your skills in cross-functional teams, where you will provide strategic and operational regulatory CMC input for biological development projects. As such, you will create results via a close dialogue with team members, affiliates and stakeholders. Your primary tasks will be to:
- Provide strategic and operational regulatory CMC input for biological development projects
- Participate in preparing global regulatory strategies and CMC strategies for biological products in development
- Identify documentation needed for simultaneous submissions in the major markets worldwide
Are you passionate about pharmacovigilance and psychiatry? Do you want to be part of a committed medical safety team engaged with the clinical development and life-cycle management of psychiatric medicine? Do you have strong background in pharmacovigilance and as a clinician, preferable in psychiatry? Do you possess the leadership skills to lead a safety team and cross-functional safety committees? If so, you may be our new Senior Safety Physician in Medical Safety Psychiatry.
Reporting to the Director of Medical Safety - Psychiatry, your responsibilities will be to lead safety teams in the Medical Safety - Psychiatry Department. You will be responsible for all aspects of clinical safety & surveillance related to allocated psychiatry projects/products.
Are you motivated by professional challenges and working in a dynamic environment?
Novo Nordisk, Måløv
Novo Nordisk Regulatory Affairs (RA) makes medicine available to patients all over the world by ensuring rapid regulatory approval in...
Novo Nordisk A/S, Søborg
Are you a skilled lab technician, passionate about stem cells and their differentiation?
Novo Nordisk, Måløv