Aseptic Technician - II

Description:

Title: Aseptic Technician - II

Location: Pearl River, NY, 10965

Job Duration: 08 months Contract (Possibility of extension)

We are seeking an entry-level to early-career Aseptic Technician / Manufacturing Scientist to support sterile pharmaceutical manufacturing operations, including final drug product processing for antibody-drug conjugates (ADCs). This role focuses on aseptic processing, sterile filling, isolator technology, cleanroom operations, and final product preparation while ensuring strict compliance with GMP, FDA, and sterility standards.

The ideal candidate will support manufacturing of sterile pharmaceutical products by performing critical tasks in controlled cleanroom environments using aseptic techniques, maintaining product integrity, and ensuring regulatory compliance through accurate documentation and procedural discipline.

Key Responsibilities:

• Perform aseptic gowning and operate effectively in cleanroom environments

• Prepare, sterilize, and transfer materials and equipment into sterile production areas

• Execute sterile manufacturing operations including:

o Sterile filtration

o Aseptic filling in isolators

o Lyophilization (freeze-drying)

o Vial sealing and final product processing

• Conduct visual inspection of vials for glass defects, product defects, and container integrity

• Support buffer preparation and downstream production activities

• Operate, monitor, and troubleshoot isolator and aseptic processing equipment

• Monitor environmental conditions and report contamination risks or process deviations

• Follow Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and safety protocols

• Maintain accurate batch records, production logs, and documentation

• Participate in cleaning, sanitization, and routine maintenance of cleanroom and manufacturing areas

• Support quality assurance, validation, process optimization, and manufacturing investigations

• Collaborate with upstream and cross-functional teams to maintain production flow

Required Qualifications:

• High school diploma or GED required Excellent job opportunity as Scientist in Cambridge, MA

• Bachelor’s degree preferred in Biology, Chemistry, Engineering, Life Sciences, or related field

• Equivalent technical training or relevant manufacturing experience may be considered

• 2–4 years of experience in aseptic processing, pharmaceutical manufacturing, cleanroom operations, or related field (entry-level candidates with relevant training also considered)

Preferred Skills & Experience:

• Knowledge of aseptic techniques and cleanroom protocols

• Experience with sterile pharmaceutical manufacturing and isolator systems

• Familiarity with GMP, FDA, and regulatory compliance standards

• Strong attention to detail and procedural discipline

• Ability to work in sterile, highly controlled environments for extended periods

• Strong troubleshooting, time management, and organizational skills

• Good communication, teamwork, and documentation skills

• Basic computer proficiency for batch record and manufacturing documentation systems

Work Environment & Schedule:

• On-site, 5 days per week

• Standard schedule: 8:30 AM – 4:30/5:00 PM during non-production periods

• During active production cycles:

o Early start times (~7:00 AM)

o Second shift work (up to midnight)

o Frequent schedule adjustments (~20 times annually)

o Occasional weekend work as needed

• Requires use of advanced PPE, including full cleanroom and isolator suits

Additional Information:

• Temporary/contract-to-permanent opportunity with long-term growth potential

• Extensive training period (6 months to 2+ years for full proficiency)

• Role requires long-term commitment due to process complexity and specialized training

Ideal Candidate Profile:

A highly detail-oriented, early-career professional who thrives in structured environments, is committed to sterile manufacturing excellence, adaptable to schedule variability, and capable of working hands-on in complex pharmaceutical production operations.