Position Responsibilities
Other duties may be assigned

• Give presentations to prospective clients on Curia process engineering capabilities
• Review client audit findings and implement corrective action where applicable
• Ensure project milestones are met and monthly deliverables are achieved.
• Attend all project kick off meetings to appropriately set client expectations and ensure standardized approaches to tech transfer.
• Reviews and approves validation protocols and final reports for client specific equipment and aseptic processing
• Ensures on-going process capability improvement
• Participates in self-development activities and training
• May establish and maintain systems to track department deliverables and trend performance against metrics.
• Ensure unit's compliance with GMP and all of its related elements such as documentation (SOP's and validation protocols, etc.)
• Develop weekly/monthly goals and manages activities through direct reports
• Attend Senior Staff meetings to develop and drive initiatives for achieving company goals

Position Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education: Bachelor’s degree in Biology, Chemical Engineering or related discipline required; Advanced degree strongly preferred

Relevant Work Experience: 10+ years’ experience pharmaceutical/biotechnology industry, experience in a cGMP/FDA regulated environment required

Knowledge, Skills & Abilities:

• Experience with clean room personnel, material flows, and aseptic processing regulatory requirements
• Knowledge of cleanroom process flows and process design; I.E. biodisposable strategies, sterile filtration, mixing strategies, fluid transfer to and from various compounding vessels/biobags
• Speciality knowledge of UF/DF, liposomal compounding/formulation strategies (ethanolic injection, extrusion), high shear mixing strategies, emulsions, suspensions, micronization techniques
• Current in cGMPs and how to implement management systems that promote cGMP compliance
• Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing program a plus)
• Ability to work with minimal supervision and interact well with clientele as well as interdepartmentally

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus .

Work Environment
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.