Job Description

You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes, but is not limited to: supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API, which includes: solid / liquid charges, atmospheric / vacuum distillations, filtrations, liquid-liquid extractions, isolations, drying, purification and milling.

ROLE RESPONSIBILITIES

• Execute Process Operating Instructions in a cGMP {part of GxP} environment.
• Responsible for equipment preparation, and cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
• Support equipment validation / commissioning activities.
• Adhere to cGMP and standard operating procedure requirements.
• Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
• Identify opportunities for continuous improvements and enable implementation.
• Maintain cross-functional communication with tech transfer team: Quality, Process Chemists, Analysists, and Process Supervisors.
• Perform troubleshooting of manufacturing support equipment and operations.
• Generate, assist, and execute documentation associated with cGMP API manufacture, such as: working batch record documentation, and in-process control sampling.
• Support Standard Operating Procedure Periodic Reviews.
• Report any deviations or observations that might lead to adverse impact on product quality.
• Actively participate in shift exchange activities and communication channels.
• Complete training to take part in safety inspections within the facility.
• Manage own time, professional development, and be accountable for own results.
• Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

Qualifications

BASIC MINIMUM QUALIFICATIONS

• High School Diploma or GED
• 4+ years of relative experience
• Demonstrated experience in a cGMP manufacturing environment.
• Operational knowledge of Production Control Systems
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Strong workload planning skills, organization, attention to detail, and follow through
• Demonstrated capability to work as an independent contributor within a matrix development team
• Excellent written and verbal communication skills
• Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel

PREFERRED QUALIFICATIONS

• Associate degree (Science or technical discipline)
• Strong mechanical aptitude and desire to execute hands on manual labor
• Experience with Delta V Production Control System
• Experience in a Pharmaceutical cGMP manufacturing environment
• Experience performing large scale distillations / Filtrations / milling

Additional Information

Position is Monday-Friday 8:00 am- 5:00 pm Overtime as needed. Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
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• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.