Manufacturing Manager (Mammalian)

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 

Reporting to the Director of Manufacturing, Manager, Manufacturing will provide leadership for the Scorpius Biomanufacturing Operations group. This entails managing all day-to-day cleanroom operations, supervising manufacturing staff, maintaining manufacturing schedules, and supporting client programs. In addition, this person will be responsible for the technology transfer of projects/processes into manufacturing from Process Development, as well as the manufacture of all cGMP-compliant, clinical-grade biologic products at Scorpius BioManufacturing.

The ideal candidate must have a strict attention to detail, high quality customer service skills and the ability to instill these qualities onto others on the team.

Key Responsibilities

• Following FDA or appropriate global regulations and guidelines, this individual will lead all cGMP manufacturing activities including the training, scheduling, and supervision of Manufacturing staff.
• Provide leadership for technology transfer from Process Development or external client teams. Responsible for collaborating with PD group to modify existing “R&D” manufacturing processes and develop them for clinical-scale, cGMP-compliant manufacturing. This includes transfer of processes into the cleanroom environment, process troubleshooting and generation of all relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures).
• Collaborate with Facilities staff in developing and managing the calibration, preventative maintenance, and validation strategy as part of the Equipment Control Program. This includes the development and implementation of operation and maintenance protocols for equipment and the execution and documentation of equipment validations.
• Collaborate with facilities staff develop, manage, and maintain the cleanroom environment ensuring compliance with global regulatory agencies at the highest-level including specifications for temperature, relative humidity, differential pressures, and air classifications.
• Support Quality Assurance group by assisting in employee training, document control, validation support, calibration, and preventative maintenance support, change control, deviation reporting, CAPA, risk analysis, etc.
• Manage relationships with outside contractors including equipment vendors, calibration and service contracts and validation firms.
• Represent Scorpius Manufacturing to outside customers and be able to respond to their questions independently and accurately.

Knowledge & Skills 

• Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.
• Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of product clinical development.
• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
• Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
• Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.

Education & Experience

• Requires a B.S. or M.S. Degree from an accredited college or university with major course work in a Scientific or Engineering discipline.
• Requires 10+ years (BS) or 6+ years (MS) of cleanroom operation and maintenance experience.
• 3 + years of manufacturing leadership with progressive responsibilities
• Requires a strong background in cGMP principles and Quality Management Systems.
• Experience working in a GMP manufacturing environment is required.
• Hand-on experience with both upstream and downstream biomanufacturing processes is essential.
• Knowledge of manufacturing processes in a mammalian or microbial system is highly desirable.
• Proven project leadership skills and experience in supervising small to medium size teams is essential.

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 ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.