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Process Scientist

Workforce Genetics

Process Scientist

Washington, DC
Full Time
Paid
  • Responsibilities

    Our client is a revolutionary early-stage biotechnology company, developing a novel cancer therapy utilizing a proprietary virally derived platform technology known as Anti-tumor Immune Redirectors (AIR). This technology redirects natural pre-existing immunity from past infections or childhood vaccines to fight cancer. This unique technology approach specifically targets solid tumor cells and causes them to appear as virally infected, resulting in a robust recall of memory immune responses against the cancer cells.

    They are currently expanding and has recently relocated their headquarters and laboratories to the new JLABs@Washington DC facility and are seeking to add a highly motivated and enthusiastic Process Scientist to join our process development team for our development programs. The successful candidate should have prior experience with process development and scale-up of protein biologics and should be comfortable working within a cross-functional team and anticipate the potential to lead with the COO, in all aspects of Chemistry, Manufacturing, and Controls (CMC) development for our recombinant expression platform, and will be responsible for providing scientific expertise as well as leading the design, production, and characterization of products from early pre-clinical development leading to a first-in-human clinical trial. Mentoring of junior scientists/technicians is also expected.

    This is an exciting opportunity to contribute to the development of new biologics drugs for cancer immunotherapy in a highly collegial start-up biotech company and gain experience in all aspects of immuno-oncology drug discovery. A high level of responsibility, flexibility, and acceptance of constructive guidance is required to carry out the diverse duties of this position.

    Key Responsibilities but not limited to:

    • Advances complex downstream process development efforts as the technical lead

    • Independently designs and executes viral nano-particle downstream process development studies.

    • Performs experiments at both large-scale and small-scale to support pre-clinical, clinical, and commercial programs. Ensures these experiments are done in a timely fashion with high quality.

    • Stays current with the latest scientific and engineering developments in the field.

    • Analyzes and interprets experimental data from process studies with a strong statistical mindset. Makes decisions based on statistically sound conclusions. Presents study results internally and externally in a cross-functional setting.

    • Develop and perform analytical assays for quality control and characterization of candidates post downstream processing using a variety of techniques and tools

    • Independently authors technical reports of studies of process development activities and laboratory experiments, such as development reports, study reports, investigational summary reports, etc.

    • Together with the COO and other cross-functional groups work closely with CDMO to advance pipeline programs. Provides support for SOPs, regulatory filings, and author sections in IND filings.

    • Mentor and guide junior team members in cell culture process characterization and validation.

    • Analyze, document, and interpret scientific research and technical data.

    Required Qualifications

    • BS, MS, or Ph.D. degree in biological sciences, chemistry, bio-medical/chemical engineering, biotechnology, biochemistry, or related fields with a minimum of 8+, 3+, or fresh to 1-2+ years’ experience, respectively in process development or cGMP manufacturing of biopharmaceuticals.

    • Comprehensive experience with a variety of biopharmaceutical purification processes such as chromatographic separation, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance.

    • Preference will be given to candidates with strong technical hands-on experience with chromatographic separation and especially tangential flow filtration experience. Specifically:

      • Experience in Tangential Flow Filtration (TFF)

      • Experience in developing and executing downstream purification processes for large macromolecules using a variety of ultra/diafiltration, etc., and chromatographic techniques that are applicable to peptides, proteins, polysaccharides, nanoparticles, and bioconjugates.

      • Proficiency with separation and purification techniques, including Hydrophobic Interaction Chromatography (HIC), and Hydrophilic Interaction Chromatography (HILIC). Ion-exchange (IEX), Size Exclusion Chromatography (SEC), and affinity purification.

    • General understanding of analytical techniques applicable to peptides, proteins, bioconjugates e.g. NMR, mass spectrometry, light scattering, HPLC, colorimetric techniques, etc

    • Experience within contract manufacturing organizations (CROs) or with the management and oversight of technology transfer to CMOs for cGMP manufacturing, Quality documentation and systems, and batch record execution and review is not necessary but will be viewed favorably.

    Salary and Benefits

    • Competitive compensation package and title commensurate with qualifications and experience in the Maryland/DC Biotech market.

    • Parking fully covered at the office

    • 100% Employer Paid Health, Dental, and Vision Benefits

    • 100% Employer Paid Basic Life & AD&D, Short-Term Disability Program

    • 15 days paid time off and 5 days paid sick leave

    • Significant growth opportunity as the company expands

    • Empathetic, supportive, and collaborative colleagues and work environment