Operations Supervisor

San Antonio, TX
Reports to:
Operations Manager

The Company

Scorpius BioManufacturing is an innovation-driven contract research, development and manufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical methods development, cGMP manufacturing and product characterization, and QC release testing needs. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.

Position Summary

Reporting directly to the Operations Manager, the Operations Supervisor will provide project leadership for the Scorpius BioManufacturing Operations group. This entails managing day-to-day cleanroom operations for specific manufacturing campaigns including preparing cleanrooms, materials, and equipment for cGMP clinical-scale manufacturing as well as supervising small Operations teams in the execution of production events.  

In addition, this person will be responsible for collaborating with the Process Development (PD) team on the transfer of biological processes from PD into Operations and into cleanroom manufacturing environments. 

The ideal candidate must have strict attention to detail, high quality customer service skills, and the ability to instill these qualities onto others on the team.

Key Responsibilities

  • Following FDA or appropriate global regulations and guidelines, this individual will manage cGMP manufacturing activities including documentation, training, and supervision of Operations project teams and manufacture of clinical-grade biologics. 
  • Collaborate on process transfer from Scorpius’ Process Development (PD) group and/or external client teams. Responsible for working with PD staff to modify existing “R&D” manufacturing processes and develop them for clinical-scale, cGMP-compliant manufacturing. This includes transfer of processes into the cleanroom environment, process troubleshooting and generation of all relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures). 
  • Collaborate with Facilities staff in executing 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. 
  • Collaborate with Facilities staff in monitoring the cleanroom environment during manufacturing events ensuring compliance with global regulatory agencies at the highest-level including specifications for temperature, relative humidity, differential pressures, and air classifications.
  • Collaborate with Operations staff in the execution of the ongoing Environmental Control Program including facility cleaning and environmental monitoring (EM) procedures. Responsibilities include the compilation and analyses of EM data (total air particulates, air viable counts, viable counts from settling plates and viable counts from contact plates) and generation of written reports.
  • 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 and Experience requirements

  • Requires a BS degree from an accredited college or university with major course work in a Scientific or Engineering discipline.
  • Requires 5+ years of cGMP biologics manufacturing in a cleanroom environment.
  • Requires a strong background with 5+ years of experience in cGMP principles and Quality Management Systems.
  • Hands-on experience with both upstream and downstream biomanufacturing processes is essential.
  • Knowledge of manufacturing processes in both mammalian and microbial systems is highly desirable.
  • Hands-on experience developing analytical test methods is desirable.
  • Proven project leadership skills and experience in supervising small to medium size teams is essential.

Knowledge and Skills

  • Outstanding interpersonal skills. Ability to build strong relationships with cross-functional team members and lead through influence.
  • Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of product clinical development.
  • Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
  • Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
  • 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.
  • Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.


  • 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 ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computers.
  • Flexibility is required. Some weekend work may be needed and earlier or later start & finish times may also be required.

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