Environmental Monitoring / Microbiology Manager

The Company

Scorpius Biomanufacturing is an innovation-driven contract research, development, and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. 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 Director, Quality Control, the Microbiology Manager will provide support in the Quality Control group at Scorpius BioManufacturing. The candidate will operate, manage, and schedule 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 training of laboratory staff, GMP document authoring / revision, providing oversight in support of GMP operations and spearheading 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.

Key Responsibilities

• Ensure department metrics and cycle times are monitored and achieved.
• Provide management and direction to microbiology and EM staff.
• Oversee daily operations and address group needs.
• Monitor environmental monitoring and testing schedule, progress, data and work quality.
• Conduct troubleshooting and OOS investigations.
• Direct 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.
• Guides/Participate in tasks associated with aseptic process simulations.
• Guides the team members on activities associated with Change Control. This includes initiation, impact and implementation of the change; also, the initiation and closure of workflows and CAPAs
• Guides, Authors and Reviews technical documents and studies to troubleshoot and support investigations.
• Mentors 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.
• Mentors and participates in internal audit discussions and coaches team to address microbial requests.
• Leads and participates in technical discussions and problem solving with outside entities (i.e., clients and contract test labs) to drive resolutions.
• Guides and integrates technical updates into the team procedures while maintaining compliance with regulatory agencies.

Education & Experience

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

Knowledge & 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 what needs to be done and develop metrics to measure the strategy.
• Are an expert in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
• Can resolve and negotiate conflicts or problems with tact, diplomacy and composure.
• Ability to handle multiple priorities with exceptional organizational and time management skills.

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.