Senior Scientist

Job Description

Job Description

The Company

Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities.

Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority.

Clients benefit from decades of expertise taking large-molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.

Position Summary

The Sr. Scientist will work within the Cell-Based Technologies group to execute and manage the development of viral vectors and other biologics products that will be utilized for clinical trial therapies.

The successful candidate will be responsible for developing and / or characterizing 1) cutting-edge viral vector plasmids and producer cell lines to achieve optimal titers and packaging quality of AAV and LVV, and 2) mammalian cell lines to produce monoclonal antibodies and other recombinant proteins (e.

g., bi-specific antibodies, fusion proteins, and antibody drug conjugates). This position also offers the opportunity to assess new technologies, perform due diligence assessments, and create a strategic plan for cell line development across product lifecycles at Scorpius BioManufacturing.

Key Responsibilities

Lead the development of vectors as well as host cell lines to deliver non-viral biologics in transient and stable transfection approaches.

This will involve managing vector design, construction, and production processes.

• Integrate cutting-edge genetic engineering techniques for optimizing cell line performance and product yield.
• Execute essential tasks related to production non-viral biological molecules. This includes transfection, selection, single cell cloning, high throughput screening, characterization of clonal cell lines using scale-down models, cell banking, and conducting cell line stability studies.
• Facilitate activities related to cell line development, including but not limited to raw materials procurement, analyzing technical transfers and process descriptions, assessing cell line stability, developing contamination mitigation strategies, and project coordination.
• Ensure cell lines are developed in compliance with regulatory requirements, focusing on safety, efficacy, and scalability.
• Collaborate with internal and external departments such as R&D, molecular biology, upstream and downstream process development, and process development analytics.
• Provide insights regarding external partnerships and acquisition of licenses. This responsibility spans the full spectrum of the product’s life cycle.
• Guide and help develop colleagues in the Cell-Based Technology group as they collaborate on innovative projects and build the necessary skills and resources to successfully deliver internal platforms and clients’ pipelines.
• Run projects and guide junior Project Leaders for various internal and clients’ programs from initial discovery through to development.
• Work closely with research and Drug Substance process development customer teams to establish systems with the desired quality and expression levels.
• Foster strong relationships with third party companies and external providers to facilitate the sharing of innovative technologies.
• Offer expertise for regulatory engagements such as inspections and audits, and responsibility for the technical content of cell line development sections within regulatory submissions.
• Analyze the intellectual property landscape of existing and emerging technologies in cell line development and create a strategic plan to maintain operational freedom.
• Assist with technology transfer processes to facilitate cell banking, cell bank analysis, and drug substance production.
• Collaborate closely with teams in discovery, upstream and downstream process development, as well as analytical development, to assist in the advancement of clients' drug substance development projects.
• Draft technical reports and deliver presentations during internal and client meetings.
• Perform other work-related duties as directed by the supervisor.

Education & Experience

• PhD or MA in Molecular Biology, Cell Biology, Genetics, or a closely related field. In addition, a minimum of four years of experience is required for those with a PhD and six years for those with an MA, with a preference for working experience in cell line development.
• Experience in DNA cloning, vector and plasmid construction and design, and genetic characterization of production cell banks.
• Significant expertise in cell line development for the production of viral vectors, monoclonal antibodies, fusion proteins, bi-specific antibodies, and other biologics modalities.
• Experience with AAV viral expression system development and production.
• Demonstrated proficiency in essential analytical methods for vector construction and cell line development. Hands-on experience with the Octet® assay, ELISA, qPCR, SDS PAGE, Western Blotting, flow cytometry and FACS are strongly recommended.
• Extensive expertise in viral vector, antibody technology, and protein expression, coupled with a solid comprehension of regulatory standards for human therapeutics.
• Experience with cell culture media formulation and operating high-throughput systems, such as the Ambr® microbioreactor and automated liquid handling system, would be advantageous.

Knowledge and Skills

• Significant knowledge and experience in vector and plasmid design, as well as a demonstrated ability in creating cell lines for viral vectors and recombinant proteins production.
• Strong organizational skills with exceptional abilities in both verbal and written communication.
• Proven ability to leverage critical thinking skills and demonstrate problem-solving capabilities.
• Extensive experience with publications in peer-reviewed journals and presentations at conferences.
• Outstanding ability to execute the method, follow SOPs, record data, and follow directions.
• Ability to take responsibility and get the job done in a high-energy, high-intensity, results-oriented environment.
• Willingness to learn and embrace new techniques and instrumentation.
• Proficient with Microsoft Word, Excel, Power Point, and Project.

Physical Requirements and Working Environment

• Flexibility is required for working hours. Some weekend and holiday work may be needed and earlier or later start / finish times may also be required.
• Candidate must be able to work in an environmentally controlled facility where noise levels are considered moderate. This position may involve a combination of office and laboratory environments.
• While performing the job’s duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.

The employee is frequently required to stand and walk. The employee may sometimes be required to lift and / or move up to 25 pounds and to wear proper gowning for a clean and controlled GMP manufacturing environment.

Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals and associated laboratory equipment pertaining to this position.