Process Development

Senior/Principal Process Development Engineer (small molecule) Direct Hire MA

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Job ID: 15020 Direct Hire MA

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Our client is a mid-size, public, drug discovery and development company with approved products on the market and several in late stage development.  This company is growing significantly - 100+ hires last year and on target to grow as much this year.  Reporting into the Associate Director of Process Development, this position will play a leadership role in the group and will manage direct reports.  This will be a hands-on lab focused role focused on design and execution of experiments with a focus on process understanding & robustness in the development of small molecule therapeutics.  
 
The main function of this role is to provide technical leadership in the scale-up and optimization of drug substance unit operations from R&D scale to cGMP Phase III manufacture. This includes reaction engineering, crystallization, process modeling and support for CMO activities. 

Responsibilities include but are not limited to;
•  Develop and scale-up drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameters and process optimization.  Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
•  Apply “scale-up/down” approaches to model drug substance unit operations in a laboratory setting
•  Design crystallization processes and apply reaction engineering and process modeling
•  Support tech transfer of drug substance unit operations and production at CMO(s)
•  Identify and deploy new technologies as needed
•  Write technical reports and author CMC sections of regulatory filing documents

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a PhD in Chemical Engineering and 5-8+ years of industry experience or BS/MS Chemical Engineering degree and 10-15+ years of experience.  Must also have experience in introducing, implementing and/or executing new chemical processes in pilot or commercial plants and experience with contract manufacturers is welcome.  Preference given to candidates with PAT experience & chemometrics (ReactIR, Raman, FBRM), and/or process modeling software (Matlab, Dynochem)

This position will be based in the suburbs of Boston & Cambridge.  Relocation assistance available for qualified candidates.  

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

Sr. Purification Scientist Direct Hire MA

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Job ID: 14883 Direct Hire MA

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Are you interested in supporting the development of traditional and single-use products and technology for the biopharmaceutical market?  Our global technology client with a focus on biotechnology & life sciences is looking to hire a Sr. Purification Scientist / Engineer in the Metrowest area of Massachusetts! This role will be responsible for the development of purification processes and technology for virus production for their clients.     

This role will focus on purification activities in the laboratory, developing processes from material produced in bench-top bioreactors through a rigorous scientific / engineering approach. The candidate ideally has experience in bioprocessing, and more specifically, with bioreactor viral vector production processes. Should be competent in the analysis and interpretation of data, and ideally have experience with plate-based, and/or qPCR assays. 

Other responsibilities include but not limited to:
•  All downstream development activities and resolution of technical problems and the monitoring of ongoing purification development campaigns.
•  Perform a wide range of assays in the molecular, cell biology, and virology testing areas of Biopharmaceutical Services.
•  Prepare reagents in support of purification and routine analytical testing.
•  Set up and execute bioprocessing runs for cell culture harvests.
•  Will present data to collaborators and will assist in writing memos, protocols and reports by organizing data and observations. 

Qualified candidates will have a BS degree and 4+ years or MS degree and 2+ years of demonstrated experience in the development of purification manufacturing processes utilizing mammalian, bacterial, and insect cell expression systems meeting GMP manufacturing requirements..  Experience in single use technology is desirable. Viral vector production/processing experience a plus.  
 

Manager, Mechanical Design Engineering Product group Direct Hire Massachusetts

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Job ID: 14640 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 Manager with a background in Mechanical Design Engineering to join their growing team in the suburbs of Boston.  

The main function of this role is to lead a small group (5-7) of Process and Mechanical Engineers that owns projects from initial inquiry until customer acceptance and directly manage their own projects.  

Responsibilities include but are not limited to;
•  Review and guide the development of User Requirement Specifications for customers and direct reports.
•  Assist direct reports and customers in the selection of equipment, technologies, and/or designs to meet design requirements. 
•  Ensure design comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
•  Monitor compliance to project scope, schedule and budget relative to the established baseline for projects executed by direct reports.
•  Ensure staff in your group complies with our established quality management system, supplies all technical documentation in accordance to the specification for the project, and executes and coordinates all qualification activities included in the project (pre-Factory Acceptance Testing, Factory Acceptance Testing, and Site Acceptance Testing.
•  Assist customers in their qualification and validation activities if requested.
•  Lead, manage and develop the team members.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BSc/MSc or equivalent in Biochemical engineering, Process engineering, Chemical engineering, Mechanical engineering, or equivalent and expertise in the design, operation, and control of cell culture bioreactors.  Must also have knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment (ASME BPE, GAMP, cGMP, ISPE).  Our client is seeking a minimum 10+ years of experience of process engineering project management of equipment used in Biopharmaceutical manufacturing including large scale and complex projects involving the integration of multiple systems.  Also seeking direct leadership experience in a technical Biopharmaceutical environment and experience in the design and engineering of bioreactors, filtration, separation and capture equipment (direct or tangential flow, filtration, chromatography systems and columns).  Must also have 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 Cambridge area or able to relocate with very limited assistance.  

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

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.