Process Supervisor, Small Scale Organics Pilot Plant

Job Description

The Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization, which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.

The SSO Process Supervisor assists on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements in addition to the existing labor contract to meet SSO objectives and customer requirements.  The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.  This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the building performance.  Ultimately, this position is expected to work cooperatively with the SSO leadership team and cross-functional SSO partners to drive overall success and performance of the building.  This role will also be responsible for the prioritization and assignment of daily activities for the operations staff.

Responsibilities:

• Ensure processes are run within the capability constraints of the facility.

• Execute batch processes as needed from either a hands-on role or a supervisory role.

• Ensure facility equipment readiness with respect to repair, cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.

• Write, issue, and review GMP documentation.

• Provide input for incident root cause analysis, reporting, and action items.

• Facilitate and drive building improvement projects and CAPA (Corrective Action and Preventive Action) completions.

• Provide input on and proficiently execute process setups.

• Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset.

• Collaborate with all building staff to share and align on best practices.

• Actively investigate problem statements and SORs (Safety Observation Reports) to promote fast and efficient problem resolution.

• Understand hazardous/high risk-work and issue permits as needed.

• Identify opportunities to improve building efficiency, compliance, and safety.

• Support training, mentoring, and coaching of operations staff.

Education Minimum Requirement:  

• Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab or pilot plant/manufacturing facility

— OR—

• High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Required Experience and Skills:

• Mechanical aptitude and familiarity with chemical process development and process equipment.

• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.

• Effective communication skills and a collaborative mindset.

• Experience in conflict resolution and root cause analyses.

• Ability to build effective work relationships with a diverse workforce.

• Adaptable to a dynamic production environment.

• Relevant experience in a process development lab or pilot plant/manufacturing facility.

• Must be able to rotate between 1st and 2nd shift on a weekly basis.

Preferred Experience and Skills:

• Lean Six Sigma Training / Certification.

• Operations experience in pilot plant or manufacturing environment.

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.