Scientist, Downstream Process Development

NexImmune

Gaithersburg, MD, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 03/26/2021
  • Website: neximmune.com
  • Company Address: 22 Firstfield Road Suite 280, Gaithersburg, MD, 20878

About NexImmune

NexImmune is an emerging biopharmaceutical company advancing a new generation of immunotherapies based on our proprietary AIMâ„¢ technology.

Job Description

We are seeking Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of downstream process development, optimization, and scale-up methodologies to develop robust and scalable production processes. Suitable candidates will have hands-on experience in all common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods (depth, traditional/single-pass TFF, virus, sterile) as well as virus inactivation (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.

Qualifications:

  • B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years of biotech industry experience in downstream process development, optimization, and scale-up.
  • Basic knowledge of GxP guidelines for the biotech industry
  • Experience with Biorad NGC and/or GE AKTA systems and protein analytical methods preferred.
  • Extensive working knowledge of all common chromatography and filtration methodologies.
  • Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
  • Proficient with the use of MS Office software (Word, Excel, Power Point).
  • Excellent problem solving, organizational, and time management skills
  • Must demonstrate initiative and be self-motivated
  • Must have excellent communication and writing skills
  • Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential
  • Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
  • Can coordinate and prioritize parallel tasks.
  • Must be flexible and able to adapt to changing demands.

Responsibilities:

  • Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
  • Develop, optimize, and scale up robust and efficient purification process for pilot production and subsequent cGMP manufacturing of Phase I candidates.
  • Screen different resins and filters systemically and then conduct follow-on optimization, process range finding, and robustness studies to optimize protein yield and purity.
  • Perform experiments using Bio-Rad NGC and GE AKTA chromatography systems, conventional and single-pass TFF systems, and industry standard filtration (harvest, sterile, viral) methods at bench and pilot-scale.
  • Participate in transfer of downstream processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
  • Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
  • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
  • Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.