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Microbial Manufacturing Operations Manager
2 months ago
Company Overview
Scorpius BioManufacturing is a specialized contract development and manufacturing organization (CDMO) focused on biologics. We provide cGMP manufacturing, bioanalytical services, and process development for protein-based modalities. Our San Antonio facility is dedicated to collaborating with start-ups, emerging biotechnology firms, and academic institutions. Founded by an experienced biotech entrepreneur, Scorpius prioritizes small-volume projects, leveraging extensive expertise to bring large molecule therapeutics to market with a commitment to Quality, Speed, Flexibility, and Responsiveness.
Position Overview
The Manager of Microbial Manufacturing will report directly to the Director of Manufacturing and will be responsible for leading the Biomanufacturing Operations team. This role includes overseeing daily cleanroom activities, managing manufacturing personnel, ensuring adherence to production schedules, and supporting client initiatives. Additionally, this position will facilitate the transfer of projects and processes from Development to Manufacturing, ensuring the production of all cGMP-compliant, clinical-grade biologics at Scorpius BioManufacturing.
The ideal candidate will possess meticulous attention to detail, exceptional customer service skills, and the ability to foster these qualities within the team.
Key Responsibilities
- Lead all cGMP manufacturing operations in compliance with FDA and global regulations, including training, scheduling, and supervising manufacturing personnel.
- Oversee technology transfer from Process Development or external clients, collaborating with the PD team to adapt existing R&D processes for clinical-scale, cGMP-compliant manufacturing. This includes transferring processes into the cleanroom, troubleshooting, and generating all necessary cGMP documentation (Batch Records, Compounding Records, Operating Procedures).
- Work with Facilities personnel to develop and manage calibration, preventative maintenance, and validation strategies as part of the Equipment Control Program, including the creation and implementation of operational protocols and documentation of equipment validations.
- Ensure the cleanroom environment meets the highest standards of compliance with global regulatory agencies, including specifications for temperature, humidity, pressure differentials, and air classifications.
- Assist the Quality Assurance team with employee training, document control, validation support, calibration, preventative maintenance, change control, deviation reporting, CAPA, and risk analysis.
- Manage relationships with external contractors, including equipment vendors and service providers.
- Act as a representative of Scorpius Manufacturing to external clients, addressing inquiries independently and accurately.
Education & Experience Requirements
- Education, training, and experience, or a combination thereof, is required.
- A B.S. or M.S. degree from an accredited institution in a Scientific or Engineering discipline is necessary.
- 10+ years of cleanroom operation and maintenance experience (BS) or 6+ years (MS) is required.
- A minimum of 3 years of progressive manufacturing leadership experience is essential.
- A strong foundation in cGMP principles and Quality Management Systems is required.
- Experience in a GMP manufacturing environment is mandatory.
- Hands-on experience with both upstream and downstream biomanufacturing processes is critical.
- Knowledge of manufacturing processes in mammalian or microbial systems is highly advantageous.
- Demonstrated project leadership skills and experience supervising small to medium-sized teams are essential.
Knowledge & Skills
- Exceptional interpersonal skills, with the ability to cultivate strong relationships across functional teams and lead through influence.
- Maintain a comprehensive understanding of phase-appropriate cGMPs applicable to various stages of product clinical development.
- Possess a working knowledge of current global regulatory requirements and guidelines, adhering to all Standard Operating Procedures (SOPs) and policies.
- Demonstrate accountability and the ability to deliver results in a high-energy, fast-paced environment.
- Excellent verbal and written communication skills, with strong presentation abilities to engage with all organizational levels.
- Proficient in Microsoft Word, Excel, PowerPoint, and Project, with good to excellent writing and computer skills.
Physical Requirements & Work Environment
- Flexibility in working hours is necessary, with potential weekend work and varying start/finish times.
- The role is primarily conducted in a controlled environment, with moderate noise levels. It may involve a mix of office and laboratory settings and the use of automated equipment.
- Job duties require regular sitting, reaching, talking, and hearing. Frequent standing and walking are necessary, with occasional lifting/moving of up to 20 pounds. Specific vision abilities required include close vision, distance vision, color vision, and the ability to adjust focus. Manual dexterity is essential for effective use of computer terminals.
