Associate Scientist I Upstream MST

San Antonio

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

Reporting directly to the Senior Manager, Manufacturing Sciences and Technology (MST), this person will provide support in the Manufacturing Sciences and Technology (MST) group at Scorpius BioManufacturing. The candidate will operate, manage, and schedule day-to-day activities to support the scale-up and manufacturing 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 upstream and downstream unit operations. In addition, the candidate must possess strict attention to detail, high-quality customer service skills, and the ability to instill these qualities in others on the team at Scorpius BioManufacturing.

An ideal candidate must have strict attention to detail, high-quality customer service skills, and the ability to work well and collaborate in cross-functional teams.

Key Responsibilities

Provide support for the scale-up and characterization from Scorpius’ Process Development (PD) group and/or external client teams.

Execute experiments with minimal supervision to support characterization, scale-up, and manufacturing activities. Accurate data recording using SciNotes and perform data analysis of project results.

Collaborate with the PD and Analytical groups to characterize and fit existing processes for clinical-scale, cGMP-compliant manufacturing.

Generation all relevant protocols, reports, and supporting cGMP documentation, including Facility Fit Analysis, Process Descriptions, Process Flow Diagrams, Bill of Materials, Manufacturing Batch Records (Process and Solution), Operating Procedures, In-process Controls, etc.

Drive collaboration with Operations, and Quality Assurance staff to:

Managing the calibration, preventative maintenance, and validation strategy as part of the Equipment Control Program. This includes the development and implementation of operation and maintenance protocols for equipment and the execution and documentation of equipment validations.

Maintain the qualification, calibration, and preventative maintenance schedule strategy for Development and Manufacturing equipment. This includes the development and implementation of operation and maintenance protocols for equipment and the execution and documentation of equipment qualifications as necessary.

Develop, manage, and maintain the cleanroom environment ensuring compliance with global regulatory agencies at the highest-level including specifications for temperature, relative humidity, differential pressures, and air classifications.

Support Quality Assurance group by assisting in employee training, document control, validation support, calibration, and preventative maintenance support, change control, deviation reporting, CAPA, risk analysis, etc.

Manage relationships with outside contractors including equipment vendors, calibration, and service contracts and validation firms.

Education & Experience

Requires a BS or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.

Experience working in a Process Development and GMP manufacturing environment is essential.

Requires 1+ years (BS), 0+ years (MS) of Process Development/MST/Biomanufacturing experience.

Requires a strong background in cGMP principles and Quality Management Systems.

Knowledge of: Both upstream and downstream biomanufacturing processes are essential.

Aseptic processing.

Wonderware, Delta V, Rockwell and Biocommand operating software.

Manufacturing processes in both mammalian and microbial systems is highly desirable.

Design of Experiments – Experimental design and analysis using statistical analysis software (i.e., SAS-JMP, MiniTab, Stat-Ease, etc.).

Experience in the development and execution of analytical test methods is required.

Knowledge & Skills

Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.

Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.

Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, PowerPoint, and Project.

Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of clinical development.

Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.

Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.

Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.

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.

While performing the job 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 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals.