Senior Kilo Chemist III: API & cGMP Specialist

Veranova; Massachusetts; On-site; USD 51,000 - 55,000; Full time

Benefits offered by this job

Health & Wellness

Financial Wellness

Professional Development

Inclusive Culture

Job summary

Veranova is seeking a Kilo Chemist III to produce Active Pharmaceutical Ingredients (APIs) at our Devens, MA facility. This 100% on-site role operates across rotating 1st, 2nd, and 3rd shifts, performing batch records and ensuring FDA/cGMP compliance while maintaining a safe, efficient production environment.

The ideal candidate holds an AA or BS in a related field with several years in regulated manufacturing, and is prepared to participate in safety programs, 5S housekeeping, and

Qualifications

• AA in Chemistry, Engineering, or other related technical field with 6+ years in a regulated manufacturing facility.
• BS in Chemistry, Engineering or other related technical field with 5+ years in a regulated manufacturing facility.

Responsibilities

• Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines; Maintain the facility in excellent FDA/cGMP position.
• Demonstrates technical proficiency and self-assuredness in applying cGMP standards; Provide process support and troubleshooting necessary to meet all customer requirements; Ensures a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
• Responsible for safety equipment and active participation in safety program and hazard analysis. Wears appropriate PPE for task; Ensures the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations.
• Ensures that waste is appropriately characterized, labelled, stored, and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
• Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately documented with current status. Works collaboratively with Maintenance, as appropriate; Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.
• Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department; Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers; Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
• Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
• Operates machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions; Complex batch processing and unit operations, such as hydrogenations, PFD operations etc; Resolve regular technical problems and takes action to ensure the production plan continues to move
• Coach, mentor and train less experienced workers on basic tasks; Participates in regular Peer to Peer training in unit operations

Education

AA in Chemistry, Engineering, or other related technical field

BS in Chemistry, Engineering or other related technical field

Job description

Veranova is seeking a Kilo Chemist III to produce Active Pharmaceutical Ingredients (APIs) at our Devens, MA facility. This 100% on-site role operates across rotating 1st, 2nd, and 3rd shifts, performing batch records and ensuring FDA/cGMP compliance while maintaining a safe, efficient production environment.

The ideal candidate holds an AA or BS in a related field with several years in regulated manufacturing, and is prepared to participate in safety programs, 5S housekeeping, and