Current Positions


Role Title: Scientist Downstream Purification

Contact and submit your resume to: info@cystinebioscience.com

Location: Gaithersburg/Bethesda, Maryland.

401K, medical, dental, vision and other benefits along with PTO.

 

Salary Range : $135K - $150K

 

Position Overview:

Scientist will lead the development, optimization, and technology transfer of downstream purification processes supporting the discovery, preclinical, and clinical development of vaccines, monoclonal antibodies (mAbs), recombinant proteins, virus-like particles (VLPs), and other biologic therapeutics. This role supports programs at NIH by developing robust, scalable, and GMP-compliant purification processes for clinical candidate manufacturing. The Scientist will collaborate with cross-functional teams to advance clinical programs, provide technical leadership in downstream process development and manufacturing support, and contribute to scientific innovation through process improvements and technology development.

 

Key Responsibilities:

 

·      Lead the design, development, optimization, and scale-up of downstream purification processes for vaccines, monoclonal antibodies, recombinant proteins, and other biologic products intended for preclinical and clinical development.

·      Develop purification workflows using chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and other downstream processing technologies to achieve target product quality, purity, yield, and process robustness.

·      Plan, execute, and oversee downstream process development activities supporting clinical candidate advancement and GMP manufacturing.

·      Design and execute process characterization and optimization studies using Design of Experiments (DOE) methodologies and statistical analysis tools such as JMP.

·      Develop scalable purification processes that support toxicology studies, clinical manufacturing, and commercial process development.

·      Lead technology transfer of downstream purification processes to GMP manufacturing organizations and provide technical support during manufacturing campaigns.

·      Prepare, review, and approve technology transfer documentation, including process descriptions, process flow diagrams, batch records, and manufacturing support documents.

·      Serve as the downstream purification Subject Matter Expert (SME) during manufacturing operations, technology transfer activities, troubleshooting, facility fit assessments, and process investigations.

·      Develop and oversee viral clearance strategies, including coordination of viral clearance validation studies, evaluation of contract research organizations (CROs), approval of scale-down validation methods, and review of validation documentation.

·      Collaborate closely with Manufacturing, Process Sciences, Quality Assurance, Quality Control, Regulatory Affairs, Analytical Development, and Project Management teams to ensure successful execution of development milestones and clinical manufacturing objectives.

·      Support regulatory submissions, including preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND) applications and responses to regulatory inquiries.

·      Review, analyze, interpret, and present scientific data, preparing technical reports, presentations, manufacturing summaries, and scientific publications.

·      Troubleshoot downstream purification challenges and implement process improvements to enhance product recovery, consistency, manufacturability, and operational efficiency.

·      Oversee downstream process execution for toxicology lot production, including review and approval of manufacturing protocols, process documentation, and final production reports.

·      Mentor and train junior scientists and laboratory personnel in downstream purification techniques, laboratory best practices, equipment operation, and scientific problem-solving.

·      Maintain accurate, complete, and well-documented laboratory records in accordance with Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), as applicable.

·      Contribute to scientific innovation through development of novel purification technologies and dissemination of research findings through scientific conferences, presentations, and peer-reviewed publications.

·      Participate in strategic planning and provide scientific guidance for purification strategies supporting new vaccine, monoclonal antibody, and biologics development programs.

 

Required Qualifications:

 

·      Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, Biotechnology, Molecular Biology, or a related life science discipline.

·      Minimum of eight (8) years of industry experience in downstream purification process development for recombinant proteins, monoclonal antibodies, vaccines, or other biologic therapeutics supporting GMP clinical-stage manufacturing.

·      Extensive experience developing and optimizing downstream purification processes, including chromatography, filtration, ultrafiltration/diafiltration (UF/DF), viral clearance, and process scale-up.

·      Demonstrated experience supporting technology transfer from process development to GMP manufacturing.

·      Strong knowledge of bioprocess development principles, process characterization, process validation, and clinical manufacturing operations.

·      Experience supporting regulatory submissions, including IND-enabling CMC documentation and regulatory interactions.

·      Proficiency with statistical experimental design methodologies (DOE) and data analysis software such as JMP.

·      Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and applicable regulatory guidelines.

·      Demonstrated ability to troubleshoot complex purification processes and develop scientifically sound, data-driven solutions.

·      Proven ability to lead multidisciplinary projects while effectively collaborating with cross-functional scientific and manufacturing teams.

·      Excellent scientific writing, technical documentation, oral communication, and presentation skills.

·      Demonstrated experience mentoring junior scientists and fostering a collaborative, team-oriented research environment.

·      Strong organizational skills with the ability to manage multiple priorities while consistently meeting project timelines.

·      Commitment to maintaining accurate, detailed, and well-organized scientific documentation.

 

Comprehensive Benefits Package

 

Health Coverage:

 

Paid Time Off:

 

Financial Security:

 

Additional Perks:





Role Title: Scientist Cell Line Development

Contact and submit your resume to: info@cystinebioscience.com

Location: Gaithersburg/Bethesda, Maryland.

401K, medical, dental, vision and other benefits along with PTO.

 

Salary Range : $130K - $150K

 

Position Overview:

Scientist will design, develop, and optimize stable mammalian cell lines to support the discovery, preclinical, and clinical development of vaccines, monoclonal antibodies, recombinant proteins, virus-like particles (VLPs), and other biotherapeutic candidates. The Scientist will independently execute cell line development workflows, including molecular cloning, stable pool generation, single-cell cloning, clone screening, and genetic characterization. This role requires close collaboration with cross-functional teams to advance therapeutic candidates while supporting technology transfer, regulatory documentation, and continuous process improvement.

 

Key Responsibilities:

·      Design, develop, and optimize stable mammalian cell lines for the production of monoclonal antibodies, recombinant proteins, vaccine candidates, and virus-like particles (VLPs).

·      Independently execute the complete cell line development workflow, including plasmid construction, stable pool generation, single-cell cloning, clone screening, characterization, and selection of high-producing clones.

·      Plan and perform gene synthesis activities, including oligonucleotide design, plasmid design, molecular cloning, and vector construction for recombinant gene expression.

·      Generate and evaluate hundreds of clonally derived CHO and HEK293 cell lines to identify optimal production candidates based on productivity, stability, and product quality.

·      Perform molecular characterization of engineered cell lines using techniques including RT-PCR, quantitative PCR, next-generation sequencing (NGS), and other molecular biology methods.

·      Design, execute, troubleshoot, and optimize experiments while independently analyzing and interpreting scientific data.

·      Utilize advanced cell engineering technologies including: Mammalian cell culture using aseptic techniques, High-throughput transfection platforms, Single-cell cloning and automated cell deposition, Flow cytometry and cell sorting, Automated liquid handling systems, Cell counting and viability analysis, Automated small-scale bioreactor systems

·      Develop experimental strategies, project plans, and timelines while managing multiple concurrent research and development projects.

·      Identify opportunities for process improvements by evaluating emerging scientific literature, implementing new technologies, and optimizing laboratory workflows to improve robustness, productivity, and efficiency.

·      Prepare and maintain detailed laboratory notebooks, experimental records, production documentation, and technical reports in accordance with Good Documentation Practices (GDP).

·      Author and review Standard Operating Procedures (SOPs), experimental protocols, technical reports, production records, and technology transfer documentation.

·      Prepare Chemistry, Manufacturing, and Controls (CMC) documentation supporting pre-IND and IND regulatory submissions.

·      Present scientific findings through internal presentations, technical reports, posters, manuscripts, and presentations at scientific conferences and symposia.

·      Collaborate effectively with multidisciplinary research, process development, analytical, manufacturing, and regulatory teams to support product development milestones.

·      Maintain, troubleshoot, and support laboratory instrumentation while ensuring proper calibration, maintenance, and operational readiness.

·      Train and mentor junior scientists and laboratory personnel on experimental techniques, laboratory instrumentation, and best laboratory practices.

·      Support laboratory operations by maintaining equipment, organizing laboratory resources, and contributing to a safe and compliant research environment.

 

Required Qualifications:

 

·      Master's or Ph.D. in Biological Sciences, Cell Biology, Molecular Biology, Biotechnology, Biochemistry, Biomedical Engineering, or a closely related scientific discipline.

·      Minimum of 2 years of industry experience in stable cell line development for vaccine, biologics, or biotherapeutic product development.

·      Extensive hands-on experience with aseptic mammalian cell culture techniques.

·      Demonstrated experience generating clonally derived CHO and/or HEK293 cell lines for recombinant protein or monoclonal antibody production.

·      Proven ability to generate, screen, characterize, and select high-producing stable cell lines from large clone populations.

·      Strong expertise in molecular cloning, plasmid design, vector construction, and recombinant DNA technologies.

·      Experience with gene synthesis, oligonucleotide design, and plasmid engineering.

·      Hands-on experience with:

·      High-throughput transfection

·      Single-cell cloning and automated cell deposition

·      Flow cytometry

·      Automated liquid handling systems

·      Automated small-scale bioreactor platforms

·      Cell counting and viability analysis

·      Proficiency in molecular biology techniques including:

·      RT-PCR

·      qPCR

·      Next-Generation Sequencing (NGS)

·      Genetic characterization of engineered cell lines

·      Experience supporting technology transfer activities and preparing documentation for regulatory submissions, including CMC sections of pre-IND and IND filings.

·      Demonstrated ability to independently design experiments, troubleshoot technical challenges, and interpret complex biological data.

·      Experience preparing scientific reports, SOPs, protocols, technical documentation, and research presentations.

 

Comprehensive Benefits Package

 

Health Coverage:

 

Paid Time Off:

 

Financial Security:

 

Additional Perks: