Process Development

Scientist I/II, Downstream Process Characterization Direct Hire MA

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Job ID: 16431 Direct Hire

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Our growing Gene Therapy client in the Burlington, MA area is looking to bring on board a Scientist I/II, Purification Process Characterization to their Process Development group!  This role will support the research and development of advanced purification methods and formulation development for AAV vectors.  Role may also involve leading activities of associate scientists.  Other responsibilities included but not limited to: 

  • Provide scientific leadership and define experimental strategy for late stage, BLA-enabling development and process characterization of cell culture systems for the production of high-quality vector products.
  • Design and apply DOE studies to explore and establish acceptable operating ranges for all purification and vector production process parameters.  Design and execute experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
  • Apply risk-based concepts to the characterization and scale-down model qualification of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
  • 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.
  • Support process development leadership to ensure that internal development activities are aligned with external manufacturing milestones and timelines
  • Collaborate within a cross-functional department (Process Development, Analytical Development, Quality, and Manufacturing) to establish robust cross-functional planning to further advance the science.

About you:

  • BS, MS or PhD in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline with 6+ years (BS/MS) or 3+ years (PhD) relevant downstream industry experience. 
  • Recent industrial experience with late-stage development and characterization of biologics or vaccine upstream process is highly preferred.
  • Expertise with GE AKTA units, column chromatography, filtration and UF/DF (TFF) operations required. Experience with High Throughput Screening platforms such Tecan will be a plus.
  • 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 technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.

Sr. Research Associate - Purification Process Development Direct Hire MA

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Job ID: 16430 Direct Hire

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Our growing Gene Therapy client here in the Burlington, MA area is looking to bring on board a Sr. Research Associate to their Purification Process Development team!  This role will support the development and optimization of purification processes (phase III readiness and tech transfer) and support studies within the team, to generate and execute experimental designs, and generate material to support experiments. Role will also lead/execute downstream purification experiments, perform assays (qPCR, ELISA, SDS-PAGE) and author technical reports. 

About you:

  • Bachelor’s or Master’s Degree in Biochemistry, Biology, Chemical/Bioengineering or other related scientific discipline with 5 plus years of downstream industry experience. 
  • Ability and desire to work in a fast-paced environment
  • Strong collaboration, team-working skills and communication skills
  • Extensive hands-on experience with Chromatography Workstations and the associated software (e.g. Unicorn® from GE or similar) along with various modes of filtration (Normal and Tangential flow modes).

Purification Tech Transfer Specialist Direct Hire MA

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Job ID: 16418 Direct Hire MA

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Exciting Purification Tech Transfer Specialist role with growing Gene Therapy company here in the Waltham, MA area.  Specialist will lead downstream process tech transfer activities for cGMP production of clinical gene therapy candidates. Work with Bioprocess Development team to define process flows, operating parameters, critical raw materials and equipment. Partner with external manufacturing team to determine timelines and tech transfer deliverables. Work closely with contract manufacturing organizations (CMOs) to communicate process needs, determine facility fit, review documentation, and provide on-floor technical support and post-production review. Includes occasional travel to US-based CMOs.  Responsibilities include but limited to:

  • Apply scientific concepts to the scale-up and scale-down of gene therapy production processes.
  • Generation of downstream manufacturing process descriptions based on bench-scale and pilot-scale data. Contribute to the generation to manufacturing bill of materials.
  • Act as primary bioprocess development downstream contact for CMOs with regard to process transfer, MBR generation/review, and post-production review.
  • Provide on-floor manufacturing support as downstream subject matter expert.
  • Review and trend process data against historical cGMP and BPD data, contribute to campaign summary reports.

Requirements:

  • Bachelor’s or Master’s Degree in Biochemistry, Biology, Chemical/Bio-engineering or other related scientific discipline with 7+ years of biopharmaceutical experience.
  • Downstream processing experience (single-use technology) at bench, pilot or manufacturing-scale.
  • Knowledge of clarification and TFF technologies.
  • Ability and desire to work in a fast-paced, start-up environment
  • Strong collaboration and team-working skills
  • Some Domestic Travel Required Occasionally

Sr. Scientist, Upstream Process Development (AAV) Direct Hire MA

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Job ID: 16385 Direct Hire MA

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Gene Therapy start-up here in the Boston/Cambridge area is looking to bring on-board an AAV Specialist (Scientist/Sr. Scientist) to lead upstream process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV manufacturing technologies and an excellent track record in gene therapy upstream process development. The successful candidate would have experience in process scale-up, process optimization, and tech transfer for GMP manufacturing.

Responsibilities include but not limited to:

  • Implement and lead upstream process development of AAV production and technical transfer to GMP.
  • Implement and/or develop innovative vector production technologies based on QbD strategies.
  • Develop protocols for vector production in shake flasks, wave bioreactors, and stirred tank bioreactors.
  • Perform monitoring of cell viability/growth and cell culture metabolites from cultures.
  • Develop intellectual property, publishing scientific papers and other tasks related to the company’s scientific and business interests.
  • Provide scientific expertise and guidance in clinical AAV production, development and innovation.
  • Author and review appropriate CMC documents for regulatory filings.
  • Participate in project related teams as a subject matter expert.

Requirements:

  • Minimum PhD in chemical engineering, biology, biochemistry, chemistry, biotechnology, or a related field and a minimum of 3 years of relevant process development experience OR an MS degree in a related field with significant experience will also be considered.
  • Experience in developing HEK293 or similar mammalian cell-based manufacturing platforms is a must. Prior experience with AAV process development and manufacturing is preferred.
  • Proficient with aseptic techniques and the use of shake flasks, wave-based bioreactors, and stirred tank bioreactors at various scales.
  • A background in cGMP, cGLP, regulatory guidelines related to pharmaceutical development, aseptic processing and process validation is a plus.

Scientist I/II, Upstream Process Development Direct Hire MA

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Job ID: 16355 Direct Hire MA

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Our large Gene Therapy client is going and looking to add a Scientist I/II to their Upstream Process Development team!  This role will focus on late-stage upstream process development efforts.  Will lead the design and execution of experimental strategies aimed at defining robust bioreactor processes for the production of AAV vectors in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production.  Other responsibilities include but not limited to:

  • Provide scientific leadership and define experimental strategy for addressing clinical development program objectives for the development and optimization of cell culture systems for the production of high quality AAV vector products.
  • Apply engineering concepts to develop and rationally 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.  Design and execute experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
  • Lead/Conduct laboratory studies to enhance AAV manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
  • Mentor associate scientists to 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:

  • PhD in Biochemical engineering, Virology, Biochemistry, or Biological Sciences with applicable academic or industrial experience in mammalian cell culture process development, or MS with 6+ 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 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.

Associate Director, Drug Substance Development Direct Hire MA

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Job ID: 15806 Direct Hire MA

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Global biopharmaceutical company here in the Woburn MA area is looking to add a Small Molecule Associate Director to their Process Development team!  Company is known for their innovative medicines to treat chronic CNS diseases and has commercial products! This position will support the development of novel active compounds within the company’s pipeline.  Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation.  Specific areas of focus include reaction engineering, crystallization and process modeling.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding & robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.  A solid background in chemical engineering is required.  Responsibilities include but are not limited to: 

  • Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of products.
  • Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization.
  • Apply reaction engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
  • Design crystallization processes that deliver solids of desired attributes
  • Support technology transfer of drug substance unit operations and production at CMO(s)
  • Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
  • Write technical reports and deliver presentations to technical, CMC and broader project groups.
  • Author & review CMC sections of regulatory filing documents
  • Mentor fellow engineers
Requirements:

  • MS in Chemical Engineering with 15+ years of experience OR PhD in Chemical Engineering with 10+ years of experience
  • Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
  • Proven ability to apply scientific principles to design, execute and interpret experiments
  • Experience in drug substance crystallization
  • Pharmaceutical cGMP manufacturing experience
  • Statistical design of experiment experience