Process Development

Sr. Research Associate, Cell Culture Process Development Direct Hire MA

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Job ID: 15772 Direct Hire MA

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Mid-Size Gene Therapy company in the Waltham, MA area is expanding!  They are looking to bring on board Sr. Research Associate, Cell Culture Process Development!  This role will conduct experiments aimed at defining robust bioreactor processes for the production of gene therapy products in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production.  Responsibilities include but not limited to: 

  • Apply engineering concepts to develop and scale the mammalian cell culture processes, including transient transfection, clarification of harvested material, and other upstream unit operations.
  • Design and apply DOE studies to develop, refine, optimize and characterize cell culture and vector production processes.
  • Conduct well-designed experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
  • Contribute to development programs to enhance manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
  • Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.

Requirements:

  • BS in Biochemical engineering or Biological Sciences with 4+ years, or MS with 2+ year of industrial experience in mammalian cell culture process development.
  • Experience with small or large-scale single-use bioreactor operations, and technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
  • Familiarity with development of viral vectors, live viral vaccines, producer cell lines, high throughput or disposable bioreactors, culture media development, or perfusion unit operations is preferred.
  • Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
  • Ability to execute and follow-through to completion and documentation. 

Principal Scientist, Purification Process Development Direct Hire MA

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Job ID: 15771 Direct Hire MA

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Mid-Size Gene Therapy company in the Waltham, MA area is expanding!  They are looking to bring on board a Principal Scientist, Downstream Process Development to their team!  This role will report into the Executive Director, Pharmaceutical Development and support the research and development of advanced purification methods and formulation development for gene therapy clinical products.  Role may also involve management activities of group members.  Other responsibilities include but not limited to:

  • Provide leadership and subject matter expertise for all downstream process and formulation development activities.  Mentor others and lead lab activities to develop downstream process with associate scientists in the lab.
  • Provide hands-on leadership in the laboratory, designing and executing laboratory experiments, leading analysis and documentation, requiring excellent writing skills and the flexibility to move between the management and execution as needed.
  • Define and drive the process development strategy for the purification of gene therapy products from mammalian cell culture by applying unit operations that are robust, scalable and suitable for cGMP production.
  • Apply engineering concepts to the screening, optimization and scale-up of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
  • Contribute to technology transfer to an external GMP CMO, generating development reports, reviewing master batch records as needed, and providing key technical support.
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
  • Provide process development leadership to ensure that internal development activities are aligned with external manufacturing milestones and timelines
  • Apply cutting edge technologies in bioprocessing to manufacturing, independently formulate new technology development initiatives and carry them to patent and public disclosure
  • Collaborate within a cross-functional department (Bioprocess Development, Analytical Development, and Manufacturing) to establish robust cross-functional planning to further advance the science.

Requirements

  • BS, MS or PhD in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline
  • 10+ years (BS/MS) or 5+ years (PhD) relevant industrial experience in bioprocessing
  • Expertise with GE Akta units, column chromatography, filtration and UF/DF (TFF) operations required
  • An in-depth understanding of purification of viral vectors, live viral vaccines, or large molecule biologics, including process scale-up and tech transfer.
  • Understanding of analytical methods used to support biologics purification process development is needed
  • Experience with high-throughput process development and statistical design of experience (DoE) preferred.
  • Experience with technical transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
  • Should be highly motivated, demonstrate strong technical leadership skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
  • Ability to execute and follow-through to completion and documentation.  Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented and good problem solving ability.
  • Experience in working with and managing outside vendors.

Sr. Purification Research Associate Direct Hire MA

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Job ID: 15770 Direct Hire MA

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Mid-Size Gene Therapy company in the Waltham, MA area is expanding!  They are looking to bring on board a Sr. Research Associate to their Downstream Process Development group!  This role will support the purification processes by improving individual unit operations or processes as a whole.  This role is expected support studies within the team, to generate and execute their own experimental designs, and generate material to support experiments.  Will work effectively both independently and as part of a cross-functional team and focused on the late-stage development arm of the process development group - encompassing process development, phase 3 readiness and tech transfer.  The role will involve purification at both the bench and pilot scales.  Responsibilities include but not limited too:

  • Actively contribute to programs to enhance purification technologies/ capabilities and work-processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
  • Independently lead and execute research experiments in the area downstream purification and supportive assays (qPCR, ELISA, SDS-PAGE) as necessary
  • Familiarity and comfort with technical writing, including internal report writing, regulatory filings, and abstracts/posters/manuscripts
  • Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
  • Ensure high-quality, timely documentation in electronic laboratory notebooks, technical reports and contribute to regulatory filings.
  • Collects and controls experimental data and maintains accurate daily logs of experiments including methods, results, and conclusions.

Requirements:

  • Bachelor’s or Master’s Degree in Biochemistry, Biology, Chemical/Bioengineering or other related scientific discipline with 1-5 years of biopharmaceutical experience
  • Downstream processing experience
  • Experience with recombinant viruses is a plus
  • Ability and desire to work in a fast-paced environment
  • Strong collaboration, team-working skills and communication skills

AD/Director of Bioanalytical Assay Development Direct Hire MA

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Job ID: 15557 Direct Hire MA

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Job Description:

Our client is a very well-funded biotech company at the forefront of developing the next wave of innovative live biologics to treat patients. They are looking for an Associate Director/Director of Bioanalytical Assay Development with relevant industry experience to join their growing team and build out this function! This is a full-time, permanent career opportunity and will work cross-functionally with scientists in the lab as well as quality and manufacturing teams for technology transfers under cGMP. Ideal candidates will leverage their industry and CMC regulatory knowledge for biological product development in various stages and apply Quality-by-Design (QbD) initiatives.

Responsibilities:

• Design and lead a small team in analytical development by working with upper management to implement new projects and oversee data tracking and trending

• Work cross-functionally with scientists to oversee assay qualification and standard operating procedures (SOPs)

• Develop non-traditional analytical methods for biologic product characterization, development, and release criteria

• Implement creative problem-solving skills to innovate solutions in a rapidly evolving company and participate in strategic and budgetary meetings to ensure goals are met

Requirements:

• Ph.D. in Life Sciences, Microbiology, Chemistry, or related field

• 6-10+ years of relevant industry experience in drug development

• qPCR and flow cytometry experience for analytical development of complex biologics or live vaccines

• Previous experience with developing analytical methods and proven track record of leadership

• Keen ability to plan experiments, analyze complex data sets, troubleshoot experiments, and present results and reports to senior management

Perks/Benefits:

• Medical, dental, vision, short-term, and long-term disability

• 401(k) plan with generous contribution

• 15 vacation days, flexible PTO, paid parenteral leave

• Join a truly passionate, motivated team to deliver on their mission of helping patients

• Free weekly lunches, discounted ride-sharing to the office, subsidized gym, and more!!

Candidates must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.