Biotechnician II (Hopewell, NJ)

Role Summary

The Biotechnician II position will directly enable the startup phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.

Responsibilities

• Facility Start-Up: Design review; Equipment selection, procurement and testing; Protocol development and execution; Acceptance testing and equipment/automation debugging; Technical training

• Hands-On cGMP Operations: Follow cGMP procedures to support manufacturing execution and automated recipes; Media preparation & transfers / filtration; Cell culture sampling, monitoring & transferring; Harvest operations; Buffer preparation & transfers / filtration; Operational and cleaning of chromatography and filtration systems; Equipment & process troubleshooting; Deviation identification, reporting, drafting, investigate closure; Change control drafting, presenting, closure; cGMP procedure development and optimization; Requesting, staging, and verifying materials for production activities; Setup and preparation of equipment for formulation and filling; Final filtration and formulation of drug product; Aseptic filling of vials inside a Grade A isolator using automated filling equipment; Performing in-process visual inspection for quality assurance; Labeling and packaging of finished drug product in compliance with cGMP; Completing batch documentation and reviewing records for accuracy; Supporting routine cleanroom operations, equipment sanitization, and environmental monitoring; Assisting in deviation investigations and participating in CAPA implementation as needed; Operation of Distributed Computer System (DSC); Operation of equipment such as Clean-in-Place (CIP), Steam-in-Place (SIP) skid, Caustic skid, autoclave, part washer, filter integrity tester, biowelders, etc.; Operation of SoloVPE protein concentration analyzer; Cleaning of the facility; Collection of samples for environmental monitoring; Removal of process waste

• Leadership Skills: Support supervisor managing day to day activities, including staff availability and task load; Self-directed leadership within both predictable and ambiguous work environments; Thoughtfully escalates issues/concerns in a timely manner as appropriate

Qualifications

• Required: High school education or GED and 1+ years‚Äô experience in biopharmaceutical company.
• Preferred: AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience.

Skills

• Computer Skills: Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.
• Other Qualifications: Evidence of good verbal and written communication; Ability to work in fast paced dynamic environment with competing priorities; Demonstrated ability to collaborate within and between diverse groups; Proactive identification and implementation of continuous improvement opportunities; Aptitude for learning moderately complex technical systems; Able to receive and incorporate feedback ‚Äì passion for ongoing professional development a plus.

Education

• High school education or GED and 1+ years‚Äô experience in biopharmaceutical company.
• AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.

Additional Requirements

• Travel: International and domestic as required
• Physical Requirements: Must be able to stand for long periods, up to 8 to 10 hours/day; reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently; work scheduled 40 hours with the ability to work overtime as needed; comfortable in varying temperatures; frequent lifting, pushing, pulling, and carrying (up to 40 lbs); regular reaching, bending, stooping, and twisting; repetitive motion; dedicated gowns depending on area; work with hazardous materials and chemicals; willing to work any shift