Senior CMC Expert/Senior CMC Project Manger

Senior CMC Expert / Senior CMC Project Manager


KLIFO is looking for a Senior CMC Expert/Senior CMC Project Manager for our Glostrup office

Would you like to use your CMC experience in a permanent position acting as a consultant to support KLIFO’s increasing number of biotech and pharma clients progressing their drug development projects?

We’re looking for a new colleague to become part of our highly experienced CMC team reporting to VP Drug Development Counselling and CMC, Hanne Wulff Nielsen.

We offer a unique opportunity to shape the content of the position and play a significant role in guiding and driving CMC development of a very broad range of international development projects and to deliver on specific CMC tasks. Our team develops tailormade CMC solutions ensuring that what we deliver to KLIFO clients and how we do it is complementary to what the client can do by themselves. Our professionalism is key and your new colleagues would have 20-40 years experience within their field.

You would become part of an international and growing company with a flexible and trustful working climate, strong focus on and interest in people and a respectful and free culture. We’re passionate about understanding our client’s needs and objectives and contribute to their projects as if they were our own.

For you to thrive and to be successful in this role you:

  • Enjoy to contribute to many different projects
  • Maneuver respectfully and curiously in different company cultures and geographies
  • Are pro-active and able to take lead
  • Have a collaborative mindset and are a flexible team player
  • Communicate confidently in writing and verbally and in Danish and English – with attention to detail

Your tasks could be to:

  • Support and advice in formulation development including documentation (protocols, reports, recommendations, presentations)
  • Develop and present CMC gap analyses, CMC strategies and plans
  • Lead CMC teams and conduct CMC project management
  • Identify CRO’s and CMO’s and facilitate collaboration
  • Draft, review or provide input to documents for correspondence with competent authorities (briefing package/scientific advice, IMPD, CTA/IND’s)
  • Prepare or review documentation to support regulatory filing (module 2.3 and module 3)
  • Support upscaling, validation and transfer of manufacturing processes to CMO’s
  • Outline statistical design of experiments
  • Plan and conduct CMC due diligence incl. reporting and recommendation

Qualifications:

  • M.Sc. (pharm.) or diploma in chemical engineering or equivalent
  • +15 years formulation development and CMC project management experience from pharma and/or biotech with either ATMP’s, biologics or small molecules
  • Particularly strong in CMC related to phase I to phase III clinical development
  • Experience preparing regulatory documentation

KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark. Most of us work partly from home and partly from the office or at our client´s offices

Contact:

For more information, please contact VP Drug Development Counselling and CMC, Hanne Wulff Nielsen, at +45 44 222 903.
If you want to meet one of your future CMC-colleagues and learn more about their experience working in KLIFO then we´re happy to arrange for that.

Applications should be sent to: moc.ofilk@boj marked Senior CMC Expert.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.


Clinical Supply Coordinator

Clinical Supply Coordinator


KLIFO is looking for a Clinical Supply Coordinator for our Glostrup office

The position as Clinical Supply Coordinator:

As a Clinical Supply Coordinaor you will support Clinical Supply Managers and be involved in supply activities, such as:

  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Control printed study specific labels
  • Coordinate return and destruction of IMP
  • File GxP documents
  • If relevant; Plan, coordinate and handle smaller clinical trials
  • Coordinate and collaborate with other CMO/CRO´s
  • Ensure high quality level to meet customer and KLIFO requirements

 

The qualifications of the Clinical Supply Coordinator:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs. Also, the person must have a positive, proactive and flexible personality.

The candidate must have relevant competencies and experiences including:

  • Pharmaconomist or equivalent
  • Experience from the pharmaceutical industry, biotech or CRO, preferably as a Clinical Supply Coordinator or similar
  • Ability to work in a flexible and changing environment
  • A high-quality mindset
  • Ability to prioritise different tasks to meet strict timelines.
  • Team oriented personality with high degree of flexibility
  • Good communication skills (written and oral), in both Danish and English

 

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Good social working environment and committed colleagues
  • Salary according to qualifications

 

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

 

Contact:

For more information, please contact Lotte Harreby, Director, at +45 44 222 960 or Pernille Smith, Team Manager, at +45 44 222 986

 

Applications should be sent to:

moc.ofilk@bojmarked “Clinical Supply Coordinator”

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR)

Deadline: 24.07.2021

View job post as a PDF.

 

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, Sweden and The Netherlands. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. Further information about KLIFO can be found at www.klifo.com