Process Characterization Specialist I

Job Description:

General Summary:

This is a temporary position currently. The PC Specialist I will be working as a key contributor in Cytovance’s late clinical phase biologics programs.  This individual will perform a variety of tasks associated with the execution of Process Characterization (PC) contracts in the R&D Services laboratories.  Task categories relate to documentation preparation and review, data entry verification in PC documents, resource scheduling and coordination, sample shipment coordination, hands-on bench work for project requirements, risk assessment, experimental designs, statistical data analysis and data reduction and reporting.  Excellent communication skills and cross-functional work experience are required.

Essential Duties and Responsibilities:

• Coordinates Cytovance resources to support day-to-day PC activities
• Delivering assignments on-time, per project schedule
• General understanding Drug Substance bioprocesses, per active project
• Supports authoring/reviewing PC documents in various stages of completion
• Organization of documentation, electronic and hardcopy
• Document archiving (scanning, and per PC work instruction)
• Ensures suitability of equipment/ instruments/ PC documentations through logbooks and batch records
• Data entry or analysis for risk assessment and experimental designs
• Data entry verification for PC documents
• Hands-on project execution including biophysical and physiochemical assays
• Clearly communicates PC work process to colleagues/ customers via meeting and presentation
• Conducts PC training
• Training on Cytovance SOPs
• Following all Health and Safety procedures
• Follows PC workflow through training/SOPs/Wis and Smartsheet/Microsoft365
• Assists PC Director to oversee PC programs

Job Requirements:

• BS/MS preferred in biochemistry or related science
• 2 years of experience in Biotechnology or CMO/CRO is preferred
• Familiarity and exposure to GLP, cGMP, and regulatory requirements
• Experience with data analysis using Excel
• Experience with monoclonal antibodies and glycoprotein analysis is preferred
• Familiarity with biologics and drug discovery/development is preferred
• Exposure to a range of protein analytical techniques, for examples, ELISA, HPLC, enzymatic, and electrophoretic (SDS-PAGE, Western blots, IEF, & CE) procedures
• Hands-on biophysical analysis (DLS, SLS, Lab Chip, MALS) is preferred
• Detail oriented and self-motivated
• Strong written and oral communication skills, proficient with Microsoft Word and Excel
• Ability to function well in a multiple project environment
• Ability to write procedure, report and correspondence
• Ability to read and interpret common scientific and technical documents 
• Ability to manage scope of work and timelines
• Ability to speak effectively before groups of customers or employees of organization

Physical Demands: 

While performing the duties of this job, the employee is frequently required to stand; sit or talk and hear. The employee is occasionally required to walk, use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment: 

While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.