Scorpius BioManufacturing is an innovation-driven contract research, development and manufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical methods development, cGMP manufacturing and product characterization, and QC release testing needs. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.
Reporting directly to the Operations Manager, the Operations Scientist will provide leadership for the Scorpius BioManufacturing Operations group. This entails managing all day-to-day cleanroom operations including supervising Operations Staff, scheduling manufacturing events, as well as execution of the ongoing Environmental Control Program. In addition, this person will collaborate on 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 strict attention to detail, high quality customer service skills, and the ability to instill these qualities onto others on the team.
- With minimal supervision, following FDA or appropriate global regulations and guidelines, this individual will independently lead all cGMP manufacturing activities including the training, scheduling and supervision of Operations staff.
- With minimal supervision, provide support 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).
- With minimal supervision, 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.
- With minimal supervision, collaborate with Facilities staff to 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 junior staff in the execution of ongoing Environmental Control Program. This includes leading 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.
Education and Experience requirements
- Requires a BS, MS, or PhD from an accredited college or university with major course work in a Scientific or Engineering discipline.
- Experience working in a GMP manufacturing environment is essential.
- Requires 5+ years (BS), 2+ years (MS) or 2+ years (PhD) of process development and/or cleanroom operation and maintenance experience.
- Requires a strong background with 2+ years of experience in cGMP principles and Quality Management Systems.
- Knowledge of both upstream and downstream biomanufacturing processes is essential.
- Experience in the development of analytical test methods is required.
- Knowledge of manufacturing processes in both mammalian and microbial systems is highly desirable.
Knowledge and Skills
- Analytical ability, both interpersonal and issue related; good judgment and ethics; professional presence and demeanor.
- 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.
PHYSICAL REQUIREMENTS and working hours
- 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 computers.
- Flexibility is required. Some weekend work may be needed and earlier or later start & finish times may also be required.
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