Senior Associate Manufacturing - Bulk Drug Substance Downstream

Job Responsibility

Completes work in accordance with established cGMP procedures and policies
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Responsible for recognizing and elevating problems during daily operations
Participate in the implementation of programs and CAPAs with an eye toward continuous improvement
Drive safety in all operations, and assist the manager in escalating concerns as needed
Maintain an organized, clean, and workable space
Draft and revise documents (SOPs, technical reports, and MPs)
Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate's Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor's Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree

Nice to have

Completion of NCBioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

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Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Job Responsibility

Requirements

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What we offer

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