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Sr. Scientist, Downstream Protein Process Development

Workforce Genetics

Sr. Scientist, Downstream Protein Process Development

Gaithersburg, MD
Paid
  • Responsibilities

    We are seeking candidates with extensive experience in developing, optimizing, and scaling up downstream processes from bench to pilot-scale; with preferably some experience working in cGMP manufacturing or regulated environment and/or a good understanding of regulatory/quality requirements.

    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. Candidates with Bio-Rad NGC and/or GE AKTA experience and having basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred. Candidates for the Senior Scientist position will demonstrate additional knowledge of, and preferably have experience with, DOE and statistical programs for design and analysis of experiments, QbD, scale-down model development and qualification, as well as process range/linkage/characterization/robustness studies.

    Candidates must have excellent technical writing skills and experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, independently determine next steps, analyze and interpret data independently, design and execute appropriately controlled experiments, 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 biotech industry experience in downstream process development, optimization, and scale-up.
    • Experience with GE AKTA systems and protein analytical methods preferred.
    • Basic knowledge of GxP policies and procedures and regulatory requirements in the biotech industry
    • Knowledge of CMC regulatory requirements for biological pharmaceutical products, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
    • Senior level candidates should have knowledge of statistical tools and DoE (incl software), QbD principles, and/or with scale-down model development/qualification, process range, linkage, and/or process characterization studies.
    • Proficient with the use of MS Office software (Word, Excel, Power Point) and Unicorn software.
    • 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
    • Plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
    • 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:
    • 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 external CMOs.
    • Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
    • Organize, interpret, analyze, and present results in clear, concise fashion.
    • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
    • Draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities
    • Maintain up-to-date GLP compliant lab notebook.