R&D Biosimilar Manufacturing Manager



Somru Bioscience Inc. is an emerging biotechnology company dedicated to developing breakthrough antibody technology for research, diagnostic and therapeutic applications. The company utilizes a unique and proprietary Somru™ technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays in a short period of time. We also offer a wide range of quality reagents for research and diagnostics applications as well as for biosimilar research and development.

Job Title:

R&D Biosimilar Manufacturing Manager

Job Duties:

  • Responsible for leading the research and development of bioprocesses for biosimilar production
  • Provide functional leadership and subject matter expertise to establish phase-appropriate cell culture-based recombinant protein/antibody production processes
  • Plan and execute experiments to evaluate downstream processing strategies and process conditions to produce high titer and product quality with high recovery rate in support of the expanding biosimilar pipeline
  • Design and implement rigorous product development strategies utilizing Design of Experiment (DoE) and other process-design elements aligned with a Quality by Design (QbD) approach
  • Facilitate process transfer, scale-up, validation and product/process comparability activities
  • Proactively identify issues, provide general guidance to resolve CMC project issues, and develop solutions to meet productivity and quality milestones
  • Deliver development reports and sections of regulatory submissions including comparability, similarity, and QbD risk assessments
  • Work closely with the assay development team to guide efforts toward specification and method of analysis development.
  • Provide hands-on and strategic leadership to a team of scientists and engineers to support company goals and activities
  • Establish and achieve budget and timeline targets
  • Support the technical team to validate and maintain equipment
  • Develop and maintain productive relationships with internal and external collaborators and partners
  • Responsible for multiple projects via cross-functional (matrix) management
  • Work in collaboration with Operations group to execute protocols, experimental plans, critical production batches, and tech transfers.



  • MS/PhD Biology, Biotechnology, Chemical Engineering or equivalent field
  • PhD with 5+ years of experience.
  • Knowledge of current GMPs, ISO, and FDA and / or European validation practices for biopharmaceutical processes
  • Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills
  • Demonstrated experience with process improvements, knowledge of manufacturing, and understanding of site operations, R&D, and production systems
  • Demonstrated success with regulatory filings including BLA submissions and product launch is preferred
  • Knowledge of SIMCA, DoE and other supportive soft wares a plus
  • Willingness to work a flexible schedule including some nights and weekends
  • Able to travel frequently


If you are interested in being considered for this position:

Email resume to: hr@somrubioscience.com


Somru BioScience Inc.

19 Innovation Way

Charlottetown, PE, C1E 0B7

TEL: 902-367-4322 | Fax: 902-367-4323

E-MAIL: hr@somrubioscience.com



Contact information

Somru BioScience Inc.
19 Innovation Way
BioCommons Research Park
Prince Edward Island, C1E 0B7