Environmental Monitoring / Microbiology Testing Specialist

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 Environmental Monitoring and Microbiology Testing Specialist will provide support in the Quality Control group. The candidate will conduct sampling for environmental monitoring, operate sampling and testing equipment, adhere to, and make improvements to quality documents under the quality management system, and perform day-to-day activities to support the Environmental Monitoring and microbiological testing programs within the manufacturing facility including clean room environments, warehouse facilities, and lab spaces as needed. This individual will be responsible for initiating/conducting investigations, GMP document authoring / revision, adherence to GMP operations and supporting initiatives to build infrastructure, processes, and capabilities across our state-of-the-art biomanufacturing facilities in the heart of historic San Antonio, TX. The ideal candidate has a keen attention to detail, is highly organized in their work with strong written and verbal communication skills.

The ideal candidate must exhibit mindfulness and good time-management skills to adapt with rapid business goals; and be organized, initiative-taking, and thrive in a fast-paced and dynamic biotech environment. She/he/they must be versatile and adapt to rapid change with a strong desire to make a significant impact at Scorpius BioManufacturing.

Key Responsibilities

• Contribute to achieving department metrics and cycle times.
• Follow directions from Microbiology management and perform daily tasks.
• Participate in daily operations and bring attention to opportunities for improvement.
• Conduct environmental monitoring and testing.
• Conduct troubleshooting and OOS investigations.
• Support the efforts and study design for qualifying new utility systems and classified areas.
• Assist manufacturing and facility departments in solving microbiology related deviation issues.
• Maintain product/project timeliness.
• Assist in creation, implementation, and administration of microbiology-based programs.
• Represent QC during regulatory inspections to respond and address EM/microbiology issues and solutions.
• Participate in tasks associated with aseptic process simulations.
• Perform activities associated with Change Control. This includes initiation, impact, and implementation of the change; also, the initiation and closure of workflows and Corrective and Preventive Actions
• Authors and Reviews technical documents and studies to troubleshoot and support investigations.
• Supports the implementation of opportunities identified to streamline data entry, analysis, and reporting of microbiological data and support implementation of changes.
• Independently find alternative solutions/work arounds while obtaining buy-in from the organization. Creative problem solving. Translates ambiguity into actional steps.
• Participates in internal audit discussions and works as a team to address microbial requests.
• Participates in technical discussions and problem solving with outside entities (i.e., clients and contract test labs) to drive resolutions.
• Brings attention to and supports integration of technical updates into the team procedures while maintaining compliance with regulatory agencies.

REQUIRED COMPETENCIES

• Able to effectively work in a dynamic/fast-paced environment Must work collaboratively with multiple departments for efficient and timely completion of assigned tasks.
• Must have strong authorship and be able to critically review executed documents and protocols.
• Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
• Must be action-oriented and customer-focused, building relationships, problem-solving, planning and organizing, conflict management, and analytical thinking.
• Must possess an independent mindset and tenacity.
• Requires moderate direction to complete complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
• Confident in making decisions for minor issues.
• Contributes to goals within the workgroup.
• Knowledge of aseptic manufacturing processes.
• Excellent verbal and written communication skills
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.
• Self-motivation and organizational skills to manage a workload independently, offering appropriate communication and escalation so solutions and support can be easily identified.

KNOWLEDGE AND SKILLS

• Understand test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.
• Ability to make good judgements and quick decisions regarding microbiological methods.
• Facilitate with organizational agility.
• Develop, guide and support strategies on how to achieve actions and develop metrics to measure the strategy.
• Can resolve and negotiate conflicts or problems with tact, diplomacy, and composure.
• Ability to manage multiple priorities with exceptional organizational and time management skills.

EDUCATION AND EXPERIENCE

• BS/BA in Life Sciences, or a related field, Biology, Microbiology preferred and
• 2+ years of relevant experience

Physical Requirements and Working Environment

• Flexibility is required for working hours. Regular 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.