Scientist II, Analytical Development

Job Duties:

• Identify and implement analytical development methodologies employed for both Plasmid and Microbiome based platforms.
• Plan and coordinate analytical development and tech transfer activities in cGMP environment.
• Implement 21CFR part 211 software
• Direct and assist in the qualification of analytical methods and stability programs including qPCR, sequencing, MALDI-TOF, ELISA, Electrophoresis, etc, in order to characterize a diverse microbial product portfolio
• Direct and assist in developing novel methodologies or optimizing existing techniques
• Analyze and interpret data collected by other team members and create reports and presentations
• Ensure analytical development deliverables are met in a timely manner
• Perform process monitoring, data analysis and data presentation in team meetings
• Perform hands-on analytical development activities related to sequencing, stability indicating assays, release assays and characterization.
  
  
  

Requirements:

Must have bachelor’s degree in bioscience, bioprocess, or biomedical engineering or a related field

Must have 6 years of experience working with assay development and validation. The stated experience must include the following:

• Developing assays for early/late-stage clinical development and commercial supply
• Designing key experiments and executing analytical assays
• Supporting tech transfer to internal Quality Control operations
  
  
  

Alternatively, we will accept a Master’s degree and 4 years of required experience or a PhD and research capability in analytical development science involving bioassays as demonstrated by past research experience or at least 1 scientific publication.

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.

For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com

URL to this page https://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3449&rmlang=UK