Society for the Advancement of Materials and Process Engineering

Senior Downstream Process Development Engineer

Evelo Biosciences
Cambridge, Massachusetts, United States
9 days ago

Description

Evelo Biosciences, Inc. (Nasdaq: EVLO) a biotechnology company developing a new modality of orally delivered, systemically acting biologics that could disrupt the industry is looking for a highly motivated individual who is energized by the prospect of working in a clinical stage company, has a strong desire to learn, and wishes to be an integral member of an interdisciplinary team.

Evelo's vision is to improve the lives of patients with serious diseases through the development of a broadly applicable new modality of medicines. Humans have evolved over millennia with the microbes in and on our bodies. These microbes play a vital role in developing and directing immune and biological responses. Evelo is harnessing the therapeutic potential of specific strains of naturally occurring microbes and developing them as a new class of medicines, monoclonal microbials. We have validated that orally delivered monoclonal microbials modulate immunological and biological effects throughout the body after initial interactions with human cells in the gut. Evelo is pioneering the development of this new class of medicine for the treatment of autoimmune, immunoinflammatory, metabolic, neurological, neuroinflammatory diseases and cancer.

This is an outstanding opportunity to join a fast-paced company in a new exciting field of medicine. As a member of the Evelo team, you will be a vital part of helping to shape Evelo’s vision: in transforming therapies through a new modality of medicines.

We are seeking a dedicated Senior Downstream Process Development Engineer who is interested in joining a highly dynamic and intellectually challenging team. This position will offer a tremendous opportunity to gain experience in design and scale-up of novel processes. In addition, this role will engage in critical collaborations with our manufacturing, microbiology, immunology, and bioinformatics teams. The successful candidate will be innovative, thrive in an intense and dynamic environment, and use his/her creative and imaginative problem-solving skills to help bring new products to patients.

Primary Responsibilities:

  • Manage operations and serve as functional area technical expert to support downstream purification and recovery process development activities including centrifugation, depth filtration, tangential flow filtration, chromatography, lyophilization, and spray drying.
  • Lead downstream process development and scaling up activities at laboratory and pilot plant for company’s product candidates.
  • Communicate goals of lab processing. Maintain lab organization and records.
  • Perform assays on products, process intermediates, and experimental samples using biotechnical strategies.
  • Conduct range finding studies for improved filtration methods, chromatography steps, and lyophilization. Measure the integrity of filters and verified results to lie within the acceptable range for manufacturing scale.
  • Conduct hands on trouble shooting, process feasibility and process optimization experiments in relation to downstream purification and recovery processes.
  • Develop purification methods to purify various product related impurities to assist product characterization.
  • Assist developed downstream process tech transfer to pilot and GMP manufacturing sites and support pilot and GMP production activities including technical review of development report, tech transfer document, batch records, SOPs, raw material release and production process report.
  • Prepare technical reports and documents to support IND and BLA filing as needed.

Desired Skills & Qualifications:

  • Strong knowledge of chromatography and membrane purification including affinity, ion exchange, hydrophobic interaction and mixed mode chromatographic separation, and harvest and ultrafiltration/diafiltration (UFDF) membrane processes. 
  • Knowledge of drying process development including lyophilization and spray drying.
  • Extensive hands on experience of column packing, AKTA/Unicorn operation and chromatographic purification process development.
  • Operation knowledge and hands on experience of membrane separation process development including depth filtration harvest and UFDF processes.
  • Knowledge and experience with manufacturing production under cGMP regulation.
  • Industry experience with tech transfer and process scaling up in related to downstream purification process.
  • Strong planning and communication skills in a dynamic project environment. Technical support experience in CMO project and communication with external customers is desired. 

Education & Experience:

  • Ph.D. with more than 5 years of biotech industry experience, or M.S with over 8 years of biotech industrial experience directly related to job description or B.S with over 10 years direct biotech industry experience and successful track record.
  • Extensive experience of downstream purification process development, process scale up from lab scale to manufacturing process for production.
  • Experience with tech transfer process from process development to GMP manufacturing site. Understand GMP regulation and FDA/EMA guidance on manufacturing process for biologics.
  • Goal oriented team player with excellent communication skills.
  • Bioengineering knowledge and experience in developing downstream purification process for manufacturing production.
  • Experience in developing high concentration UFDF process.
  • Experience with supporting CMO projects and communication with external customers is a plus.

About Evelo Biosciences

Evelo Biosciences is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic and neurological systems. The company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

Evelo currently has four product candidates in development: EDP1815, EDP1867 and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

Notice: Roles that take place fully on-site/in office will require Covid-19 vaccination.



Requirements

Desired Skills & Qualifications:

  • Strong knowledge of chromatography and membrane purification including affinity, ion exchange, hydrophobic interaction and mixed mode chromatographic separation, and harvest and ultrafiltration/diafiltration (UFDF) membrane processes. 
  • Knowledge of drying process development including lyophilization and spray drying.
  • Extensive hands on experience of column packing, AKTA/Unicorn operation and chromatographic purification process development.
  • Operation knowledge and hands on experience of membrane separation process development including depth filtration harvest and UFDF processes.
  • Knowledge and experience with manufacturing production under cGMP regulation.
  • Industry experience with tech transfer and process scaling up in related to downstream purification process.
  • Strong planning and communication skills in a dynamic project environment. Technical support experience in CMO project and communication with external customers is desired. 

Education & Experience:

  • Ph.D. with more than 5 years of biotech industry experience, or M.S with over 8 years of biotech industrial experience directly related to job description or B.S with over 10 years direct biotech industry experience and successful track record.
  • Extensive experience of downstream purification process development, process scale up from lab scale to manufacturing process for production.
  • Experience with tech transfer process from process development to GMP manufacturing site. Understand GMP regulation and FDA/EMA guidance on manufacturing process for biologics.
  • Goal oriented team player with excellent communication skills.
  • Bioengineering knowledge and experience in developing downstream purification process for manufacturing production.
  • Experience in developing high concentration UFDF process.

Job Information

  • Job ID: 59990988
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Senior Downstream Process Development Engineer
  • Company Name: Evelo Biosciences
  • Job Function: Process Development
  • Job Type: Full-Time
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