Drug product project leader / no-720

Location
Switzerland
Start
19.04.2022
End
19.04.2023
Workload
80 - 100 % %
All-in / Hour
Rate see job description
Total Hours
1920

Deadline:

 

Drug product project leader / no-720

Location
Switzerland
Workload
80 - 100 % %

Start

19.04.2022

End

19.04.2023

DEADLINE

  • Switzerland
  • Basel19.04.202219.04.202380 - 100 % % 1920Rate see job description

For our customer located in Switzerland we are currently looking for a: Drug product project leader  (m/f/d)

  • Location: Basel
  • Duration: 19.04.2022 – 19.04.2023

Tasks & Responsibilities

  • As Drug Product Project Leader you will be the strategic lead of Drug Product Development within Biologics projects and be accountable for agreed upon deliverables to the CMC team
  • Lead and coordinate the global drug product sub-team (functional experts from e.g. Formulation and Process Development, Analytics, Production, Devices or Regulatory) and represent Drug Product Development on the global CMC team.
  • Author or review regulatory CMC documents and communicate with health authorities, if required
  • Oversee and contribute to design, planning, performance and interpretation of scientific experiments for the pharmaceutical development of stable liquid and lyophilisate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process; upscale and transfer of processes and support if process validation and registration of the product
  • Responsible for resource and budget planning of drug product development activities internally and externally. Proactively communicate project strategy and resource demand. Adapt project strategy and prioritize project activities as needed.
  • You will be working in multidisciplinary and international teams, reporting scientific/technical results internally and representing our customer externally at meetings, giving talks, being part of industry consortiums, publishing papers.

Must Haves

  • Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
  • Minimum of 2-5 years of successful experience in biotech / pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
  • Experience in protein analytics, lyophilization, primary packaging development for biologics as well as regulatory submissions is an advantage.
  • Excellent scientific leadership skills, interdisciplinary thinking and proven ability to work in cross-functional, international teams.
  • Strong presentation skills and scientific/technical writing skills
  • Please provide job description.
  • English Fluent, German a plus

 

 

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Tagged as: 2-5 years of successful experience in biotech / pharma industry, Analytics, Biochemical Engineering, Devices or Regulatory, Drug Product Project Leader, Ph.D. in Chemical Engineering, Pharmaceutical Technology, Process Development, Production

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • Switzerland
  • Basel19.04.202219.04.202380 - 100 % % 1920Rate see job description

For our customer located in Switzerland we are currently looking for a: Drug product project leader  (m/f/d)

  • Location: Basel
  • Duration: 19.04.2022 – 19.04.2023

Tasks & Responsibilities

  • As Drug Product Project Leader you will be the strategic lead of Drug Product Development within Biologics projects and be accountable for agreed upon deliverables to the CMC team
  • Lead and coordinate the global drug product sub-team (functional experts from e.g. Formulation and Process Development, Analytics, Production, Devices or Regulatory) and represent Drug Product Development on the global CMC team.
  • Author or review regulatory CMC documents and communicate with health authorities, if required
  • Oversee and contribute to design, planning, performance and interpretation of scientific experiments for the pharmaceutical development of stable liquid and lyophilisate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process; upscale and transfer of processes and support if process validation and registration of the product
  • Responsible for resource and budget planning of drug product development activities internally and externally. Proactively communicate project strategy and resource demand. Adapt project strategy and prioritize project activities as needed.
  • You will be working in multidisciplinary and international teams, reporting scientific/technical results internally and representing our customer externally at meetings, giving talks, being part of industry consortiums, publishing papers.

Must Haves

  • Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
  • Minimum of 2-5 years of successful experience in biotech / pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
  • Experience in protein analytics, lyophilization, primary packaging development for biologics as well as regulatory submissions is an advantage.
  • Excellent scientific leadership skills, interdisciplinary thinking and proven ability to work in cross-functional, international teams.
  • Strong presentation skills and scientific/technical writing skills
  • Please provide job description.
  • English Fluent, German a plus

 

 

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Tagged as: 2-5 years of successful experience in biotech / pharma industry, Analytics, Biochemical Engineering, Devices or Regulatory, Drug Product Project Leader, Ph.D. in Chemical Engineering, Pharmaceutical Technology, Process Development, Production

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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