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 Associate Scientist will provide technical support for the Scorpius BioManufacturing Operations group. This entails managing day-to-day cleanroom operations for specific manufacturing campaigns including preparing cleanrooms, materials, and equipment for cGMP clinical-scale manufacturing as well as of execution of production events.
In addition, this person will be responsible for collaborating with the Process Development (PD) team on the transfer of biological processes from PD into Operations and into cleanroom manufacturing environments.
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 limited supervision, following FDA or appropriate global regulations and guidelines, this individual will manage cGMP manufacturing activities including documentation, training, and supervision of Operations project teams and manufacture of clinical-grade biologics.
- With limited supervision, collaborate on process transfer from Scorpius' Process Development (PD) group and/or external client teams. Responsible for working with PD staff 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 limited supervision, collaborate with Operations staff in the execution of the ongoing Equipment Control Program including facility cleaning 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.
- With limited supervision, 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.
Education and Experience requirements
- Requires an Associate's or Bachelor's degree from an accredited college or university with major course work in a Scientific or Engineering discipline.
- Requires 2+ years of cGMP biologics process development or manufacturing in a cleanroom environment.
- Requires a strong background with 2+ years of experience in cGMP principles and Quality Management Systems.
- Experience in both upstream and downstream biomanufacturing processes is desirable.
- Familiarity of manufacturing processes in both mammalian and microbial systems is desirable.
- Experience with execution of analytical test methods is desirable.
Knowledge and Skills
- Outstanding interpersonal skills. Ability to build strong relationships with cross-functional team members.
- Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of product clinical development.
- 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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