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Microbiology Environmental Monitoring Manager

2 months ago

San Antonio, United States Scorpius Biomanufacturing Full time
Job DescriptionJob 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

The Microbiology Manager will join a newly formed Quality team and report to the QC Director. This person is responsible for the governance of the GMP facility environmental monitoring and contamination control program including the qualification of the GMP facility and maintaining the qualified status, aseptic process simulation, disinfection procedures/practices, disinfectants qualification, cleaning validation, and oversight of microbiological testing of raw materials, intermediates, drug substance, and finished goods. The Microbiology Manager is also responsible for the development, implementation, and compliance of activities in the microbiology laboratory area to meet production goals, quality, and cost objectives. The Microbiology Manager will be expected to have extensive knowledge and experience in developing and implementing contamination control methodologies in pharmaceutical or biological industries.

This position plays a lead role within Scorpius’ GMP process, works closely across Scorpius Quality, Manufacturing and Process Sciences teams to ensure that ongoing programs meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Scorpius BioManufacturing.

Duties and Responsibilities

  • Understands and effectively communicates to team members about contamination control and Sterility Assurance practices
  • Ensures that team objectives align with key Company strategic goals and programs
  • Successfully manages and meets agreed-upon milestones for key Company projects
  • Develops and implements appropriate systems to achieve a level recognized as aseptic excellence
  • Serves as the primary subject matter expert in Microbiology, aseptic processing, and Contamination Control risk assessment and mitigation strategies
  • Interacts with Facilities, manufacturing, and operations support teams who are responsible for disinfection procedures/practices
  • Oversees the completion of projects through the development and approval of schedules, project plans, master plans, protocols, and reports for systems to support laboratory and contamination control plan
  • Oversees the Gowning Qualification and Training Program
  • Coordinates activities of QC personnel engaged in environmental sample collection, processing, and data evaluation
  • Oversees shipment and testing of microbial samples contracted to CTOs
  • Assigns analysts to specific testing functions and executes tests when needed
  • Supports, mentors, trains and educates sterility assurance owners in planning and executing the contamination control processes, best practices, and record/documentation content
  • Provides leadership and direction for laboratory test/method validation, media qualification, and disinfectants qualification; support for validation protocol development and execution including bioburden recovery efficiency studies, mycoplasma, endotoxin, and sterility
  • Supports day-to-day functions and initiatives regarding contamination control, including staffing, sample collection, processing, and quality control of test methods
  • Leads investigations to environmental excursions and assists with CAPAs
  • Ensures the proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements
  • Develops, writes, and revises SOPs
  • Recommends implementation of new laboratory equipment
  • Maintains thorough documentation of environmental monitoring studies; performs data trending
  • Maintains current working knowledge of regulations that may have an impact on role
  • Other duties as assigned.

Required Education & Experience

  • 7 to 8 years of experience with a bachelor’s degree or 5 years with a Master’s in microbiology (preferred).
  • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements, and effectively manage the performance of assigned staff with a minimum of three years in a management position
  • Strong knowledge of pharmaceutical microbiology and contamination control
  • Sound knowledge of aseptic processing and supporting technologies
  • A minimum of 5 years of cleanroom facility and microbial rapid test methods validation experience
  • Previous experience working with non-conformances, and corrective action and preventive action processes
  • Experience writing and reviewing technical documentation
  • Practical knowledge of GMP facility qualification and Aseptic Process Simulation is required.
  • Expertise in Outlook, MS Word, Excel, PowerPoint, Microsoft Project, Adobe Acrobat Professional and other software applications.

Skills & Competencies

  • Excellent verbal and written communication skills
  • Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication skills
  • Strong problem-solving and analytical skills with a demonstrated ability to manage several projects simultaneously is a must
  • Must have excellent oral, written, and interpersonal skills
  • Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines
  • 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.
  • Strong organization, problem-solving, and time-management skills.
  • Good interpersonal, verbal, and written communication skills in English.
  • Must be action-oriented and customer-focused, building relationships, problem-solving, planning and organizing, conflict management, coaching others, and analytical thinking.
  • Requires moderate direction to complete complex tasks; completes routine tasks with little or no supervision. Work is self-directed.

Physical Requirements and Working Environment

  • The position is hybrid
  • Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
  • While on-site 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, color vision, and the ability to adjust focus.
  • The employee must have manual dexterity and manual ability to effectively use computer terminals.