Process Development

Sr. Scientist, Purification Process Development Direct Hire MD

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Job ID: 15249 Direct Hire MD

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Mid-Size biologics company here in the Rockville, MD area looking to bring on board a Sr. Scientist, Purification Process Development!  Will be responsible for the development, optimization, and scale-up of GMP compliant downstream process for biologics.   Also responsible for the development of novel and optimization of current purification processes, scale-up and transfer to clinical manufacturing sites. This is an exciting, hands-on role and will execute product recovery, clarification, purification and formulation process development, as well as process scale-up and tech transfer to GMP manufacturing.  Other responsibilities include but not limited to: 

  • Design purification strategies, investigate purification parameters, including product recovery, clarification, purification and formulation; using statistical DoE for process characterization/optimization where applicable.
  • Works hands-on to develop, optimize and scale-up downstream processes using small to large scale purification systems in the laboratory setting for the purification of biologics.
  • Performs standard analytical methods to characterize biologics-HPLC, SDS-PAGE, Western Blot, spectrophotometer.
  • Designs and Executes process monitoring and control strategies for robust process design.
  • Confirms scalability of unit operations during process development and anticipates equipment related scaling issues.
  • Manages project and people, trains junior associates on procedures and processes.
  • Provides person-in-plant support for cGMP manufacturing of pre-clinical and clinical study materials.
  • Authors Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission.
  • Collaborates with upstream and assay development groups to coordinate material needs.
  • Supports the execution of start-up and commissioning of equipment and processes.
  • Reviews Process Descriptions, and Batch Records during tech transfer.

Requirements:

  • Ph. D in Biochemistry, Chemistry, Chemical Engineering or Biological Sciences. & 3+ years of purification process development experience OR MS with 6+ years of DSP experience. 
  • Hands-on experience with the operation of AKTA series of chromatography skids and current filtration technologies (Both Normal Flow Filtration and Tangential Flow Filtration) are required.
  • Knowledgeable of cGMP manufacturing and cGMP compliances.
  • Proven leadership in developing and improving scalable purification processes in PD settings.
  • Knowledgeable with current analytical methods used for downstream assessment, and for clinical lots testing.
  • Design and conduct process characterization and assessment of critical process parameters.
  • Support regulatory filing.

***Able to travel as needed.

Purification Process Development - Project Leadership Direct Hire MA

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Job ID: 15167 Direct Hire MA

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Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area and they are seeking an experienced Purification Process Development professional at the BS/MS level to join their growing team!  This is a fantastic opportunity for someone with experience in various downstream unit operations to lead projects and manage relationships with external partners and vendors while still being hands-on in the lab.  

The main function of this role is to lead one one or more aspects of the following activities; Process Development, Process Characterization, and Technology Transfer

Responsibilities include but are not limited to;
•  Development, scale-up, and manufacturing activities in support of viral vector manufacturing platform for early and late stage development..
•  Screening, optimization, and scale-up of chromatography and filtration processes.
•  Scale down model development and process characterization activities.
•  Technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a minimum of a BS and 6+ years or a MS and 3-5+ years of directly related experience.  PhD level candidates can also be considered for a Scientist-level role.  Must have experience with chromatography (affinity, IEx, HIC, SEC) and filtration processes (microfiltration, depth filtration, UF/DF, and sterile filtration).  Experience with high-throughput process development techniques and statistical design of experiment (DoE) as well as knowledge of GMP/ICH/FDA regulations preferred.  Cell or Gene therapy experience is a plus but not required.  

Must be authorized to work in the US indefinitely to be considered.  This position will be based in Cambridge, MA and some relocation assistance is available.  

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

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.