Sr Bioprocess Associate

1. JOB SUMMARY

The primary role of this position is to provide technical support for all fill finish operations with strict adherence to cGMP compliance.  The candidate will also provide guidance for all on-floor activities including aseptic fill operations, visual inspection, labeling, and packaging of bulk product with minimal supervision.  This position requires proficiency in aseptic technique, and deliberate movements inside various isolators.  The candidate for this position will be working in close association with Technical Operations, Quality Assurance, Quality Control, and Material Management to overcome challenges in meeting the production schedule.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Execute daily tasks such as washing and sterilizing vials and filling components for use in production operations.  Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/post production.
• Perform Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
• Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
• Author and revise batch records and SOPs.
• Perform routine reviews on executed batch records and logbooks.
• Initiate deviations, CAPAs, and Change Controls.
• Generates Purchase requisitions for consumables items within the MFG department.
• Assist in activities related to other onsite departments such as the execution of validation protocols.
• Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
• Perform tasks under minimal supervision, and within tight time lines to meet production schedule.
• Report any unexpected observations and suggest possible explanation and resolution.

Requires vaccination against different viruses including Vaccinia virus.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BS/BA in Biology, Chemistry, or related discipline
• 1-3 years’ experience in a GMP facility or High School Diploma and at least 5 years’ experience in a GMP facility.
• Good interpersonal skills and attention to detail.
• Analytical, organized, self-motivated, and good at multi-tasking.
• Previous experience working with aseptic technique and good documentation practices is required.
• Must be able to follow cGMP regulations during operations including adherence to written procedure and contemporaneous documentation.
• Must be able to communicate effectively with management and staff.
• Must be able to record data accurately and legibly.
• Demonstrated mechanical aptitude and have manual dexterity.
• Ability to perform in a team setting in a controlled environment for long periods of time.
• All candidates must pass a 20/20 near sighted vision screening and the color blindness test.