Process Development

Associate Scientist, Process Development Direct Hire MA

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Job ID: 15121 Direct Hire MA

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Growing mid-size biologics company here in Cambridge, MA looking to bring on board an Associate Scientist/Engineer, Process Characterization to their team!  This role will support late stage characterization studies of cellular therapy manufacturing processes.  They are looking for a Scientist/Engineer with a cellular processing background and process characterization experience, preferably in cell and gene based therapies.  Responsibilities include but not limited to:

  • Complete technical work related to stem cell biology, viral gene transfer, and molecular biology, including tissue culture, flow cytometry and RT-PCR.
  • Execute predetermined study protocols to support process characterization for cell-based therapy products.
  • Performs large scale processing of apheresis collections using automated cell processing technology. Performs CD34+ selection on Sepax and ClinicMACS.
  • Performs transduction of stem cells with vectors in small and large scale format.
  • Maintains accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation.
  • Participates in writing/reviewing characterization plans and protocols, interpreting data and managing experimental timelines to meet corporate goals

Requirements:

  • BS or MS cell biology, immunology or related discipline with at least 3+ years' experience in the biotechnology or pharmaceutical industry. Stem cell therapies is a plus.
  • Demonstrated experience with process characterization, including Quality by Design (CQA, CPP and risk assessments)
  • Direct experience in authoring and review/approval of process characterization and validation protocols and reports
  • PCR skills and minimal Flow Cytometry assay exposure is preferred.
  • Prior cGMP manufacturing experience for clinical-stage products, ideally supporting late stage clinical trials/product commercialization
  • Proficiency in mammalian cell culture is mandatory

Mechanical Design Engineer/Project Manager (Downstream Equipment) Direct Hire Massachusetts

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Job ID: 14209 Direct Hire Massachusetts

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Our client is a Fortune 1000 company with broad capabilities in filtration, separation and purification.  They are seeking an experienced Mechanical Design Engineer to join their growing team in the suburbs of Boston.  

As a Project Manager, you will serve as technical leader and owner from initial inquiry until customer acceptance.    

Responsibilities include but are not limited to;
•  Define technical process (technology selection, sizing, design testing etc.) and provide technical proposal and costing for the proposed solution.
•  Own the project execution and guide a multidisciplinary team from inception through project completion (establish the project plan, coordinate project team activities, report progress).
•  Control project scope, schedule and budget relative to the established baseline.
•  Establishing functional specification and define and creation of instrument, valve, apparatuses and fitting lists.
•  Ensure design complies with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
•  Execute and coordinate all qualification activities included in the project (pre-Factory Acceptance Testing, Factory Acceptance Testing, and Site Acceptance Testing).
•  Work with outside subcontractors including mechanical fabricators, electronic fabricators, Software designers and automation experts.
  
Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in Mechanical engineering and 5+ years of experience in process engineering / project management of equipment used in Biopharmaceutical manufacturing involving the integration of multiple
systems.  Those with degrees in related fields (Biochemical, Process, or Chemical Engineering) may also be considered.  

Preference given to those with experience in the design and engineering of process equipment for filtration, separation and purification equipment (direct or tangential flow, filtration, chromatography systems and columns etc.) used in a
downstream process and/or experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry. 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs of Boston or able to relocate with very limited assistance.  Approximate travel for this role is not expected to exceed 10% on a
yearly basis.    

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