Process Development

Sr. Director, Gene Therapy Development Direct Hire MA

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Job ID: 15966 Direct Hire MA

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Our global Gene Therapy client is looking to bring on board a Director/Sr. Director, Gene Therapy Development to their team!  This person will lead a team and the Gene Therapy Development at their MA site.  Will oversee the development and optimization of their viral vector platforms and develop the manufacturing processes for candidates in the gene therapy pipeline.  Will be responsible for upstream and downstream activities on multiple platforms, as well as the in-process analytical method development and testing.  Other responsibilities include but not limited to:

  • Work in close partnership with the Head of Manufacturing (Gene Therapy) to support GMP manufacturing of clinical supplies, including generation of cell and viral banks necessary to support process development and clinical manufacturing.
  • Work closely with the Research group to facilitate seamless movement of projects through the development continuum.
  • Employ innovative approaches to ensure company develops and implements state of the art viral vector manufacturing platforms for clinical and commercial products, working in close partnership with internal and external experts to realize this goal. 
  • Keep current on trends, new products and technologies, and regulatory requirements that may have an impact on the corporation’s development and manufacturing plans. 

Qualifications:

  • PhD in a life science and at least 8 years of experience in gene therapy development, or an MS and 10 years of experience, or a BS/BA and 12 years of experience.
  • Candidate must have excellent leadership abilities, a deep technical understanding of viral vector manufacturing platforms, experience with managing a scientific team, and a proven scientific track record of publications and presentations.
  • Experience with a variety of viral vector platforms desired (e.g. baculovirus, producer cell line, etc.).
  • Ability to work transversally with multiple stakeholders and to develop and manage a strong team is required.

Relocation is available for qualified candidates.  Must be eligible to work for any U.S. Employer for an indefinite amount of time. 

VP, Cell Culture Development Direct Hire MA

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Job ID: 15965 Direct Hire MA

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Our Global Biologics client has an exciting Sr. Director/VP, Cell Culture Development opening here in MA!  This role will lead the global oversight of the biologics cell culture development and create the long-term strategy, and corresponding goals to propel the Biologics Development team as an industry leader.  Responsibilities include but not limited to: 

  • Cell line development: Development of production cell lines for expression of therapeutic proteins, and related technologies for improving efficiency and expression levels
  • Medium / Feed development: Development of platform medium / feed that would result in robust, industry leading titers for fed-batch and continuous manufacturing processes
  • Process Development: Develop fed-batch and continuous cell culture processes for a growing portfolio of products, at all stages of development
  • Process Characterization: Responsible for process characterization, and parameter criticality assessment in preparation for process validation activities
  • Regulatory Submissions: Responsible for authoring of relevant regulatory sections
  • Support technology transfer to Down Stream manufacturing and troubleshooting of manufacturing batches
  • Define vision and strategic plan for Cell culture to accommodate new modalities and technology evolution
  • Responsible for a global team of over 100 scientists and engineers across three sites

Requirements: 

  • Ph.D. in Chemical / Biochemical Engineering, or a related field AND at least 15 years relevant industrial experience with at least 5 years managing a large team (>30) of scientists / engineers. 
  • Global leadership experience leading / influencing multi-cultural teams is highly desired.
  • Should have demonstrated ability to develop cell culture processes for large number of therapeutic proteins of different modalities (mAbs, fusion proteins, bispecifics etc.), high titer platform media / feed, and robust cell lines. 
  • Experience in transfer of process to clinical and/or commercial site, and scaling up to ~10,000L bioreactor scale.
  • Experience with process modeling / process controls, using mathematical / statistical approaches
  • Experience with scale-up / scale-down of processes and use of high throughput systems.
  • Leadership of CMC team(s), demonstrating knowledge of various aspects of biologics drug development.

Relocation is available for qualified candidate.  Must be eligible to work for any U.S. Employer for an indefinite amount of time.  

Principal Scientist, Process Development (Small Molecule) Direct Hire MA

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Job ID: 15934 Direct Hire MA

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Global biopharmaceutical company here in MA is looking to add a Small Molecule Principal Scientist to their Drug Product Development team!  Company is known for their innovative medicines to treat chronic CNS diseases and has commercial products! 

This position will provide technical leadership for small molecule batch and continuous drug product unit operations, scale-up and optimization in development from R&D to GMP Phase 3 manufacture to process validation.  Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  Responsibilities include but are not limited to:

  • Collaborate within cross-functional teams, specifically with Formulation and Analytical Development to define and execute development strategies that enable successful launch of products
  • Implement scale-up strategies for small molecule batch and continuous drug product unit operations with a focus on process understanding, identification of critical process parameters and process optimization
  • Active role in establishing a continuous drug product manufacturing pilot plant
  • Apply particle engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
  • Design manufacture processes that deliver drug product of desired attributes
  • Support technology transfer of drug product 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 10+ years of experience OR PhD in Chemical Engineering with 3+ 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
  • Continuous process development and manufacturing
  • Pharmaceutical cGMP manufacturing experience
  • Statistical design of experiment experience

Preferred but not required:          

  • PAT experience and chemometrics (e.g. NIR, Raman)
  • Experience in working with DEA controlled substances
  • Quality by Design experience

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

Sr. Manager/Sr. Scientist, TCR/CAR-T Process Development Direct Hire MA

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Job ID: 15781 Direct Hire MA

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Are you experienced in TCR/CAR-T Process Development and looking for your next career move?  Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This role is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main focus of this role is defining and driving the scientific strategy for engineered T cell process development efforts and to serve as technical liaison between the research immunology and manufacturing operations functions.

Responsibilities include but are not limited to;

•  Development, qualification and characterization of engineered T cell processes including the establishment of critical process parameters and controls for manufacturing using common cellular therapy equipment including but not limited to: Wave Bioreactors, Haemonetics Cell Saver 5, Elutra Cell Separator, Controlled rate freezers, LOVO cell washer, Multisizer 4 Coulter counters, CliniMACS, etc.
•  Serve as technical liaison between the research immunology and manufacturing operations functions.

•  Troubleshooting cell culture upstream productivity and product quality issues at clinical manufacturing scale.  The Hiring Manager can also consider those without at scale T-cell processing if experienced in CAR-T activation of T-cells or assessment of T-cell potency.

•  Support IND and BLA filings.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS and 10-15+ years or a PhD and 5-10+ years of industry experience in the development of cellular and gene therapies with a strong background in T cell biology and Immunology. Industry experience is welcome but not required to be considered.  A strong background in relevant assays such as FACS, ELISA, qPCR, Cytotoxicity, Proliferation, and Luminex is expected.  Experience with large scale, closed system manufacturing of therapeutic cell and/or gene therapy products from whole blood, apheresis, or bone marrow is preferred.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

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. 

Sr. Manager/Sr. Scientist, Cell Culture Process Engineering Direct Hire MA

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Job ID: 15707 Direct Hire MA

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Are you an experienced Cell Culture Process Engineer looking to make the jump to cell & gene therapy?  Already in cell & gene therapy and looking for your next career move?  Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This role is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

Responsibilities include but are not limited to;
•  Cell culture upstream process scale up, tech transfer, manufacturing support, data compilation and analysis.
•  Bioreactor and/or platform selection and optimization (Perfusion systems, WAVE bags, single-use systems, etc.), characterizing mass transfer coefficient & mixing time for bioreactors, characterizing cell culture harvest.
•  Troubleshooting cell culture upstream productivity and product quality issues at clinical manufacturing scale.
•  Use of various "omics" tools (proteomics, transcriptomics, metabolomics, etc.) to advance process understanding mammalian cell-based processes and drive development, scale-up and technology transfer activities.   

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS and 10+ years of industry experience or a PhD and 5+ years of industry experience in a cell culture, process development environment and good understanding of bioprocess engineering concepts.  Cell therapy and/or gene therapy experience is welcome but not required to be considered.  Experience in statistical analysis or modeling is preferred.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

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.