CCRM Nordic Process Development Manager

3 weeks ago

Gothenburg, Västra Götaland, Sweden CCRM Nordic AB (svb) Full time
CCRM Nordic Process Development Manager & Team Lead

Looking for an exciting opportunity to lead a position at CCRM Nordic contributing to Sweden's vision of becoming leader in Advanced Therapy Medicinal Products (ATMPs)?

Consider applying for the Process Development Manager & Team Lead role at CCRM Nordic.

About CCRM Nordic

CCRM Nordic is a newly established national infrastructure for commercialization of advanced therapy medicinal products (ATMPs).

CCRM Nordic is a not-for-profit company based in GoCo Health Innovation City, Mölndal that aims to build process development and GMP ATMP manufacturing capabilities during the coming years.

CCRM Nordic vision is to benefit patients by enabling commercialization of advanced therapies.

Position

Process Development Manager & Team Lead

CCRM Nordic office at GoCo Health Innovation City Mölndal Gothenburg, Sweden

Full time, 100%

About the role


The Team Lead role will act as a Line Manager and steer process development efforts aimed at advancing novel therapeutic approaches, contributing to the optimization and scale-up of manufacturing processes for cell and gene therapy products.


This role will be based in our offices at GoCo Health Innovation City and reports to our Chief Technology Officer.


Main tasks and responsibilities:


The work is performed in cross-functional teams that include Process development, Manufacturing, QA/QC and external suppliers in a highly collaborative, competent, and engaged environment.


  • Lead process development activities for the optimization and scale-up of cell and gene therapy manufacturing processes.
  • Support and lead the team in the design and execution of experiments to evaluate and improve cell culture processes, gene editing techniques, and/or downstream purification methods.
  • Together with the team, develop and implement robust analytical assays to monitor critical quality attributes of therapeutic products.
  • Analyze data, troubleshoot technical challenges, and propose innovative solutions to enhance process efficiency and product quality.
  • Collaborate with research and development teams to transfer technologies from early-stage development to manufacturing.
  • Author and review technical documents, including protocols, reports, and regulatory submissions, to support process development activities.
  • Participate in cross-functional project teams to ensure alignment of process development goals with overall project objectives.
  • Stay current with advancements in cell and gene therapy technologies, contributing to the continuous improvement of process development strategies.
  • Line manage and provide technical guidance to team members, fostering a collaborative and innovative work environment.
  • Maintain compliance with regulatory standards and company policies, ensuring the safety and quality of experimental procedures and therapeutic products.

Qualifications/Skills:

  • Ph.
D. or MSc degree in Bioengineering, Chemical Engineering, Molecular Biology, or a related field.

  • Minimum of 5 years of experience in process development within the biotechnology or pharmaceutical industry, with a focus on cell and gene therapy preferred.
  • Expertise in mammalian cell culture techniques, media optimization, and bioreactor operations.
  • Proficiency in gene editing technologies such as CRISPR/Cas9, lentiviral vectors, or adeno-associated viruses (AAVs).
  • Strong understanding of process development principles, statistical analysis, and Quality by Design (QbD) concepts.
  • Experience with analytical methods for the characterization of cell-based products, including flow cytometry, qPCR, ELISA, and cell-based assays.
  • Excellent communication skills and the ability to effectively collaborate with multidisciplinary teams.
  • Proven leadership abilities, with a track record of successfully leading projects and line managing team members.
  • Familiarity with regulatory requirements for cell and gene therapy products, including cGMP guidelines and FDA/EMA regulations.
  • Highly organized, detail-oriented, and capable of managing multiple projects simultaneously in a fast-paced environment.
Why work at CCRM Nordic


This is an opportunity to make a real impact in the field, shaping the direction of regenerative medicine in the Nordics together with a dedicated enthusiastic team.

You should be based around the Gothenburg region and able to attend our Mölndal office on a regular basis.

Application


Please submit your application as soon as possible to as interviews will be held continuously as strong applicants are identified.

Please label your application with "Team Lead Process Development".

Closing date:
June 30, 2024.

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