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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. Our San Antonio facility is dedicated to supporting start-ups, emerging biotech firms, and academic institutions. Founded by an experienced entrepreneur in the biotech sector, Scorpius prioritizes small-volume projects, leveraging extensive expertise to facilitate the market entry of large molecule therapeutics. Clients can expect exceptional Quality, Speed, Flexibility, and Responsiveness.
Role Summary
The Manager of Manufacturing will report directly to the Director of Manufacturing and will be responsible for overseeing the Scorpius Biomanufacturing Operations team. This role includes managing daily cleanroom activities, supervising manufacturing personnel, maintaining production timelines, and supporting client initiatives. Additionally, this position will oversee the transfer of technologies and processes from Development to Manufacturing, ensuring the production of all cGMP-compliant, clinical-grade biologics.
The ideal candidate will possess a keen attention to detail, exceptional customer service abilities, and the capacity 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.
- Facilitate technology transfer from Process Development or external client teams, collaborating with the PD group to adapt existing R&D processes for clinical-scale, cGMP-compliant production. This includes transitioning processes into the cleanroom, troubleshooting, and generating necessary cGMP documentation.
- Work with Facilities personnel to develop and manage calibration, preventative maintenance, and validation strategies as part of the Equipment Control Program, including creating and implementing operational protocols.
- Ensure the cleanroom environment meets global regulatory standards, managing specifications for temperature, humidity, pressure differentials, and air classifications.
- Assist the Quality Assurance team with employee training, document control, validation support, and compliance activities.
- Manage relationships with external contractors, including equipment vendors and validation firms.
- Act as a representative of Scorpius Manufacturing to external clients, providing accurate and independent responses to inquiries.
Qualifications & Experience
- Education, training, and experience in a relevant field.
- B.S. or M.S. degree in a Scientific or Engineering discipline from an accredited institution.
- 10+ years of cleanroom operation experience (BS) or 6+ years (MS).
- Minimum of 3 years in a leadership role within manufacturing, with increasing responsibilities.
- Strong understanding of cGMP principles and Quality Management Systems.
- Experience in a GMP manufacturing environment is essential.
- Hands-on experience with both upstream and downstream biomanufacturing processes is crucial.
- Familiarity with manufacturing processes in mammalian or microbial systems is highly advantageous.
- Demonstrated project leadership skills and experience supervising small to medium-sized teams.
Skills & Competencies
- Exceptional interpersonal skills, with the ability to build strong relationships across functional teams and lead through influence.
- Maintain a comprehensive understanding of phase-appropriate cGMPs relevant to product clinical development.
- Familiarity with current global regulatory requirements and guidelines, adhering to all Standard Operating Procedures (SOPs).
- Ability to take ownership and deliver results in a dynamic, high-pressure environment.
- Strong verbal and written communication skills, with the ability to present effectively at all organizational levels.
- Proficient in Microsoft Office Suite, including Word, Excel, PowerPoint, and Project.
Physical Requirements & Work Environment
- Flexibility in working hours is required, with potential weekend work and variable start/finish times.
- Work is typically performed in a controlled environment with moderate noise levels, involving both office and laboratory settings.
- Regularly required to sit, reach, and communicate; frequent standing and walking may be necessary. Ability to lift and/or move up to 20 pounds may be required. Specific vision abilities include close vision, distance vision, and the ability to adjust focus.
