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Form of workJob Description
Position Summary
Reporting directly to the Vice President, Manufacturing Operations, Senior Manager, Operations will provide leadership for the Scorpius Biomanufacturing Operations group. This entails independently managing all day-to-day cleanroom operations including supervising Operations staff, scheduling manufacturing events, as well as management of the ongoing Environmental Control Program. In addition, this person will be responsible for the technology transfer of projects/processes into Operations from Process Development, as well as the manufacture of all cGMP-compliant, clinical-grade biologic products.
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 Operations staff.
Provide leadership for technology transfer from Scorpius’ Process Development (PD) group and/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.
Supervise staff in the execution of ongoing Environmental Control Program. This includes developing and implementing facility cleaning procedures and environmental monitoring (EM) procedures. Responsibilities include the compilation and analyses of EM data (total air particulates, air viable counts, viable counts from settling plates and viable counts from contact plates) and generation of written reports.
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 the Scorpius biomanufacturing capabilities to outside customers and be able to respond to their questions independently and accurately.
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 15+ years (BS) or 10+ years (MS) of cleanroom operation and maintenance experience.
Requires a strong background with 10+ in cGMP principles and Quality Management Systems.
Experience working in a GMP manufacturing environment is essential.
Hand-on experience with both upstream and downstream biomanufacturing processes is essential.
Knowledge of manufacturing processes in both mammalian and microbial systems is highly desirable.
Hands-on experience developing analytical test methods is desirable.
Proven project leadership skills and experience in supervising small to medium size teams is essential.
Knowledge & Skills
Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.
