Process Development

Associate Director, Process Characterization Direct Hire MA

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Job ID: 14749 Direct Hire MA

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Mid-Size Biologics company here in Cambridge, MA seeking an Associate Director, Process Characterization to join their elite team! This role will manage and support team activities including development and qualification of scale down models, designing process characterization studies, interpreting results to establish a process control strategy, writing process characterization and validation protocols and reports, gap assessment and risk assessments, etc. This person will collaborate across all functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities. Other responsibilities include but not limited to:

  • Responsible for defining and driving a scientific strategy for characterizing and validating large scale manufacturing procedures using a risk-based approach
  • Responsible for defining and maintaining deliverables for the late stage process development team through process commercialization
  • Responsible for leading the documentation strategy including generation of protocols, reports and revision of batch records to support the process characterization campaign and establishing a suitable process control strategy
  • Promote and ensure efficient and timely readiness for PPQ campaign in close collaboration with internal and external interfaces
  • Act a technical liaison at the interface with external manufacturing organizations (CMOs) and quality, regulatory and manufacturing groups
  • Author and review appropriate sections of regulatory filings
  • Manage experimental timelines and budgets to meet corporate goals

Requirements:

  • Ph.D in chemical engineering or biological sciences with at least 8+ years of relevant experience including management experience or MS 12+ years of relevant experience and demonstrated scientific thinking expertise
  • Technical understanding and experience in biopharmaceutical process manufacturing operations and equipment in an industrial cGMP environment
  • Experience with quality by design (QbD) and Design of Experiments (DoE) approaches to process characterization using statistical software such as JMP or Minitab for applications of statistical process control
  • Strong scientific and technical mastery including superior technical writing and presentations. Direct experience authoring Risks Assessments, Process Characterization and Validation protocols and reports.

Head of Upstream Development north of Boston Direct Hire MA

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Job ID: 14654 Direct Hire MA

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Our client is a small, specialized biologics CRO with operations in Massachusetts, Europe, and Asia.  They are expanding their local site and are seeking an experienced individual to play a leadership role in Upstream Process Development for Cell Line Generation and Bioprocess Development.  

The main function of this role is to lead a small group providing services that include DNA cloning, mammalian cell line generation, upstream process development (mammalian, microbial & insect cell platforms), purification development, and product characterization.

Responsibilities include but are not limited to;
•  Bioprocess development including selection and development of media (preferably for mammalian based processes) to meet aggressive timelines. 
•  Generate, manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements.
•  Report and present results periodically and participate in regular meetings with clients.
•  Identify, attract, and retain high quality scientists.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a MS or PhD in a life science or related discipline and at least 10+ years experience in a biotechnology or biopharmaceutical industry environment with a proven background in protein production.  Must also have at least 5+ years of experience in a supervisory role.

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.

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.

Director, Process Chemistry (New Technologies) Direct Hire MA

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Job ID: 14631 Direct Hire MA

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Our client is a growing and profitable specialty API company in Massachusetts.  This company is the leader in their segment of the industry and they are seeking a Director of Technology to develop next generation process chemistry and manufacturing processes.  

The main function of this role is developing and executing innovation strategy with a goal of achieving step-change improvement of large scale commercial cGMP API manufacturing, including COGS (cost of goods) reduction. 

Responsibilities include but are not limited to;
•  Build and lead a diverse group of approximately 4-6 chemists & chemical engineers in a new technology/process development setting
•  Work with key internal departments at multiple locations in the US as well as external partners 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have PhD in organic/synthetic chemistry or Chemical Engineering and 7-10+ years of relevant industry experience in a cGMP Process Chemistry or Process Development setting.  Experience in process development related to peptides and/or manufacturing / CMO experience in the generic API field is a plus.  Must have leadership experience to be considered, if not direct reports, than Group Lead/Team Lead experience.

Must be authorized to work in the US indefinitely to be considered.  This position will be based in the suburbs of Boston.  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.

Vice President, Process Development Direct Hire MA

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Job ID: 14372 Direct Hire MA

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Our client is a growing and profitable specialty API company in Massachusetts.  They are seeking a VP of Development to oversee Process Development groups at their Massachusetts locations and another site out of state.  This company is the leader in their segment of the industry and this role will will have high visibility in the company as well as the industry.  Reporting to the President, this position will serve alongside of the VP of Operations, the VP of Business Development, the VP of Quality and Reg Affairs, and the Heads of Finance and HR to form the Site Leadership team charged with setting and implementing business and operational strategy for the business.

In addition to the Development groups listed above, this position will build and lead a new Innovation group at the company with a total team size of about 30 between all sites currently. 

The main function of this role is to set technical strategy and lead the process development and innovation groups.  

A formal description can be supplied for interested candidates. 

Qualified candidates will have PhD and 15+ years of experience leading Technical Development groups in either small molecule or therapeutic peptides/oligonucleotides.  Must have demonstrated expertise in scientific management in a pharmaceutical manufacturing business required.  CMO or CRO experience highly preferred.  

Must be authorized to work in the US indefinitely to be considered.  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.

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.