CMC Project Manager

Immunotherapies for life

Broad and clinically advanced product pipeline
Y-mAbs Therapeutics A/S is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutic products for the treatment of cancer. Y-mAbs has a broad and clinically advanced product pipeline, including two late-stage and clinically validated product candidates.

As CMC Project Manager for Y-mAbs, you will get the opportunity to contribute to state of the art research and be a part of a fantastic journey. With direct report to SVP Technical Operations, you will manage, coordinate and drive the Chemistry, Manufacturing and Control (CMC) part of projects in early and late stage development with specific focus on analytical and stability issues.

Also, the coordination of development activities within drug product formulation, assay development, control strategies, and quality control using external vendors (CRO’s) together with writing and reviewing the technical content of the regulatory documents for submissions will be some of your tasks. Furthermore, you will be involved in the outsourcing process, from quotations and contract negotiations to follow-up and troubleshooting with CMC partners as all manufacturing is outsourced.

Scientific background and CRO experience
There could be several entries to this job, and your background could be one of the following: As a Scientist, Project Manager, or another equivalent position employed in R&D within biotech or pharmaceutical industry and working with CRO’s. You hold a PhD or M.Sc. in pharmaceutical sciences, engineering or biological sciences. Bioassays and formulation development of proteins experience is an advantage. Additionally, you possess the ability to communicate fluent in English, both written and orally.

Moving forward in your career
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. Please submit your CV and application in English on www.compasshrg.com – If you would like to find out more about this position before submitting your application, please do not hesitate to contact Senior Research Consultant Joan Hemmingsen from Compass on tel.: +45 70 20 12 75. Please note that we will reply to the email address from which you send your CV.

Y-mAbs Therapeutics A/S is a Danish affiliate of Y-mAbs Therapeutics Inc., which is located in New York. Our mission is to discover, develop and deliver novel antibody therapeutics for the treatment of both pediatric and adult cancer patients. Working at YmAbs, is therefore a unique chance to be part of a small, Danish biotech company with global impact! YmAbs is a true entrepreneurship, where you will get the chance to make a difference. The organisation is literally too small for you to hide – you will be put on the spot and expected to contribute to state-of-the-art research. See more at www.ymabs.com

Deadline for application: As soon as possible
Workplace: 
Hørsholm
Reference: 1803.160
Company:
Y-mAbs Therapeutics

Contact:


Medical Advisor

Diabetes & Cardiovascular in Denmark

Disease awareness and pre-launch activities
As Medical Advisor for Sanofi, you will provide medical and scientific expertise and service for the diabetes and cardiovascular (DCV) team in Denmark. You will report directly to the DCV Medical Head Denmark and be a part of the Nordic & Baltic Medical Affairs organisation.
Sanofi has interesting products in the pipeline within both disease areas and you will be a crucial part in preparing the launches. This means that you will have an extrovert position having peer to peer discussions with key opinion leaders, discussing, developing and setting up relevant studies and data generation and projects as well as providing medical education internally in Sanofi and externally.

Scientific background and external engagement skills
There could be several entries to this job, and your background could be one of the following: As a Medical Advisor, or another related experience as a Medical Doctor employed in a pharma function in R&D, Medical- or Regulatory Affairs. You could also have experience as a Medical Doctor from a hospital, with the ambition to pursue a career in the pharma industry. Furthermore, clinical and therapeutic experience within diabetes or cardiovascular from studies or research is considered an advantage and ideally with launch experience.
Additionally, you possess the ability to communicate, collaborate and influence with excellent communication and networking skills.

Moving forward in your career
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. Please submit your CV and application in English on www.compasshrg.com – If you would like to find out more about this position before submitting your application, please do not hesitate to contact Senior Research Consultant Joan Hemmingsen from Compass on tel.: +45 70 20 12 75. Please note that we will reply to the email address from which you send your CV.

Sanofi is the world’s third largest producer of pharmaceuticals, and Europe’s leading pharmaceutical company with more than 100,000 employees in over 100 countries. The global headquarters are located in Paris, and in Denmark we have our current base in Hørsholm (will move to Copenhagen in 2018), where about 60 employees work within marketing, clinical investigation and information. In Denmark, we are proud of our history, our values, and our commitment to contribute to health. Our goal is to offer drugs for both prevention and treatment of diseases, and to ensure patients an improved quality of life within our seven major therapeutic areas. See more at www.sanofi.dk

Deadline for application: As soon as possible
Workplace: Hørsholm
Reference: 1703.425
Company: Sanofi

Contact:

 

Medical Advisor, Medical Information

Nordic and Baltic Region

Knowledge center of excellence for Sanofi Genzyme
As Medical Advisor, Medical Information for Sanofi Genzyme in the Nordic and Baltic (NOBA) region, you are the medical expert responsible for delivering medical information about Sanofi Genzyme’s medicinal products and therapeutic areas within specialty care, including Rare Diseases, Multiple Sclerosis, Oncology, Atopic Dermatitis and other areas in Immunology. Through a close collaboration with your local and international colleagues, you will provide scientifically and medically balanced replies to all incoming medical inquiries from patients and Health Care Professionals. The overall purpose of the job is to make a difference for the patients through setting high medical and scientific standards for Sanofi Genzyme’s Medical Information, and further develop this function in NOBA into a knowledge center of excellence for Sanofi Genzyme’s medicinal products and therapeutic areas.

Strong scientific background and excellent communication skills
There could be several entries to this job, and your background could be one of the following: Maybe you already have a background as a Medical Advisor or a Medical Information Manager in a pharma affiliate, or you have another related experience as a Medical Doctor employed in a pharma headquarter function in e.g. Drug Safety, Medical- or Regulatory Affairs. Finally, you could also have experience as a Medical Doctor from a hospital, and wants to pursue a career in the Pharma Industry.

Personally, you have excellent communication and interpersonal skills. Furthermore, you have great time management skills with the ability to plan and be accurate in the execution of these.

Take the next step forward in your career
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. Please submit your CV and application in English on www.compasshrg.com – If you would like to find out more about this position before submitting your application, please do not hesitate to contact Research Consultant Tina Gissel from Compass on tel.: +45 70 20 12 75. Please note that we will reply to the email address from which you send your CV.

Sanofi is the world’s third largest producer of pharmaceuticals, and Europe’s leading pharmaceutical company with more than 100,000 employees in over 100 countries. The global headquarters are located in Paris, and in Denmark we have our current base in Hørsholm (will move to Copenhagen in 2018), where about 60 employees work within marketing, clinical investigation and information. In Denmark, we are proud of our history, our values, and our commitment to contribute to health. Our goal is to offer drugs for both prevention and treatment of diseases, and to ensure patients an improved quality of life within our seven major therapeutic areas. See more at www.sanofi.dk

Application deadline: As soon as possible
Work place: Hørsholm
Reference: 1703.408
Company: Sanofi Genzyme

Contact:

Country Quality Head (CQH)

Exciting opportunity for a Responsible Person

Maintain high quality standards
Sanofi is a unique, dynamic, and well reputed place to work, and the local affiliate holds more than 90 employees. In this position, you take on a key-role in the continued search for quality excellence in Denmark supported by the Nordics and Baltics (NoBa) Quality Head and your NoBa colleagues.

Key role as Responsible Person
As CQH, you will be the GDP Responsible Person for the Danish affiliate, and play a key role for the management and oversight of all quality activities. It is your main responsibility to ensure, that the quality processes and systems are in place and documented for all GDP activities and with oversight on GXP activities, and to prepare for country quality audits and GDP regulatory inspections. You will actively be managing and escalating deviations, gaps and recalls as well as conduct affiliate training in Sanofi Quality standards and regulatory requirements. Finally, you will have responsibility for the quality oversight on outsourced GXP Service Providers.

Proactive and analytical personality with great communication skills
We expect you to have a master degree in Pharmacy or MSc in a field relevant to this position, combined with minimum 4 years´ of experience in a QA setting within the Pharmaceutical industry. You have in depth knowledge of the requirements in the regulated industry, and you are experienced in GDP. You might already have obtained the role as RP or have the competencies to do so. You operate in a very communicative, decisive, structured, proactive, and analytical manner, and you have the ability to deliver positive and critical communication and foster excellent working relationships with stakeholders at any level of the organization and at external authorities.

As a person, you are outgoing and have a high level of positive energy as well as the ability to define, plan, and prioritize the activities that will drive your targets. You master Danish and English at a high level.

How to join Sanofi
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you need further information about the position, please contact Director Tom Zehngraff at 70 20 12 75. All enquiries will be handled with confidentiality. If interested, please apply as soon as possibly through our webpage www.compasshrg.com. Applications will be processed on an ongoing basis independently of the deadline. Therefore, we ask you to apply as soon as possible to make sure that your application is taken into consideration.

Sanofi is one of the world’s largest producer of pharmaceuticals, and Europe’s leading pharmaceutical company with more than 100,000 employees in over 100 countries. The global headquarters are located in Paris, and in Denmark we have our base in Hørsholm, where about 90 employees work within marketing, clinical investigation, and information. In Denmark, we are proud of our history, our values, and our commitment to contribute to health. Our goal is to offer drugs for both prevention and treatment of diseases, and to ensure patients an improved quality of life within our seven major therapeutic areas. See more at www.sanofi.dk

Deadline for application: As soon as possible
Workplace: Hørsholm
Reference: 1701.086
Company: Sanofi

Contact:

Medical Advisor

Multiple Sclerosis – Denmark

Sanofi Genzyme is one of the World’s leading companies, who has specialized in developing medicine to patients with rare diseases. Sanofi Genzyme is now looking for a skilled Medical Advisor to cover the multiple sclerosis therapeutic area in Denmark.

Increase awareness by utilizing your professional and scientific knowledge
Sanofi Genzyme has a strong presence in the MS market with one treatment, and has recently launched a new treatment for patients with highly active forms of sclerosis. Your responsibility will be to cultivate new knowledge and continuously increase the awareness of these treatments through interesting scientific dialogues with KOL’s and other relevant stakeholders. As Medical Advisor, you will therefore have a broad variety of responsibilities being involved in everything from research, development of new strategic studies, presenting scientific data, supporting the sales teams, and developing strong relations with the KOL’s.

This is your opportunity for a highly interesting role with lots of responsibility and independence, and where you get to combine a strong scientific approach with interesting extrovert activities.

Extrovert personality with a strong scientific background
We expect you to have a scientific educational background with a strong medical/clinical knowledge. This makes you able to quickly acquire a strong product- and disease knowledge including clinical and health economics aspects. It is an absolute advantage if you have already obtained knowledge in the multiple sclerosis field. Personally, you have an extrovert preference combined with excellent communication and interpersonal skills.

Take the next step forward in your career
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. If you would like to find out more please do not hesitate to contact Morten Islin, Partner in Compass on tel.: +45 70 20 12 75 or submit your CV in English on www.compasshrg.com – Please note that we will reply to the email address from which you send your CV.

Sanofi is one of the largest pharmaceutical companies in the world, and Europe’s leading pharmaceutical company with more than 100,000 employees in over 100 countries. The global headquarters are located in Paris, and in Denmark we have our base in Hørsholm, where about 60 employees work within marketing, clinical investigation and information. In Denmark, we are proud of our history, our values, and our commitment to contribute to health. Our goal is to offer drugs for both prevention and treatment of diseases, and to ensure patients an improved quality of life within our seven major therapeutic areas. See more at www.sanofi.dk

Application deadline: ASAP
Work place: Hørsholm
Reference: 1703.024
Company: Sanofi

Contact: