Scientist I, Manufacturing Sciences and Technology (MST), Downstream

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 

Reporting directly to the Downstream Manufacturing Sciences and Technology (MST) Team Lead, this person will support downstream processing activities for the Manufacturing Sciences and Technology group at Scorpius Biomanufacturing. The candidate will be responsible for scaling up and transferring methods for manufacturing operations and production of pre-clinical and clinical-grade biologics, including protein therapeutics, cell-based therapies, and plasmid and viral vectors. This individual will collaborate and interface with the Process Development and Operations groups on the technology transfer, facility fit, process characterization, and scale-up of downstream unit operations. This position will require excellent technical, analytical, and problem-solving skills, along with the ability to operate independently on progressively more complex activities and projects at Scorpius BioManufacturing.

Key Responsibilities

• Independently plan and execute tech transfer-related projects involving diverse downstream unit operations. These include, but are not limited to buffer and solution preparation, various filtration and ultrafiltration methods, centrifugation, chromatography, column packing and qualification, various sterilization methods, aseptic technique, vialing and labeling, process data recording, and trending.
• Transfer processes into the cleanroom environment and support the execution of Engineering and cGMP manufacturing campaigns.
• Generation all relevant cGMP supporting documentation, including Facility Fit Analysis, Process Descriptions, Process Flow Diagrams, Process Models, Bill of Materials, Manufacturing Batch Records (Process and Solution), Operating Procedures, In-process Controls, etc.
• Complete required documentation in an accurate and timely manner, adhering to written procedures and regulatory requirements.
• Manage relationships with outside contractors including equipment vendors, calibration, and service contract and validation firms.

Knowledge & Skills 

• Ability to function independently; plan, execute, and record experiments.
• Ability to maintain the highest standards of accuracy and attention to detail.
• Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
• Excellent verbal and written communication skills; ability to gather, interpret, report, and present data.
• Excellent writing and PC skills with a knowledge base in Microsoft Excel, Power Point, Word and Project.
• Ability to identify problems and solutions then take action to resolve them.
• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.

Education & Experience

• BS, MS, or PhD from an accredited college or university with major course work in a Scientific or Engineering discipline.
• Requires 5+ years (BS), 2+ years (MS), or 0-2 years (PhD) of Process Development / MST / Biomanufacturing experience.
• Experience in the biopharmaceutical industry is required.
• Technical proficiency in recombinant protein purification using chromatography (AKTA) and TFF systems is required.
• Experience with Design of Experiments – Experimental design and analysis using statistical analysis software (i.e., SAS-JMP, MiniTab, Stat Ease, etc.), highly desirable.

Physical Requirements and Working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.