Location: Thousand Oaks, CA
Term: 10 Months *with possible extension*
Title: Exception-Manufacturing Specialist

Why is the position open?

• Additional Resources needed due to demand

Top 3 skill sets:

• Ability to manage multiple projects, technical writing skill, experience in a cGMP area with SME process knowledge

Day to day responsibilities / first 30 days:

• Author and manage quality reports and projects, as needed

Employee value proposition:

• Experience in a dynamic environment building valuable technical skills

Possible extension:

• Possible

Interview process:

• Interview will be conducted by FLMs, Sr Managers and peers.

Job Summary:

• This Specialist Manufacturing position is within Client Thousand Oaks Drug Substance Supply (Manufacturing) organization. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations within the global network.
• Job scope and responsibilities:
• This is a Process Owner role providing broad operational support to the manufacturing floor.
• Requires strong scientific, technical interactions with partner organizations such as PD, CPE and F&E.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
• Owns and maintains the manufacturing production schedule. Coordinates with New Product Introduction leads, Supply Chain and Planning, Facilities and Engineering as well as Manufacturing to ensure the production schedule is accurate and up to date.
• May support Manufacturing in troubleshooting Non-Conformance events, conducting problem solving and RCAs, owning class 2/3 Company, and works with Quality, F&E, EH&S, PD, CPE etc to develop and own CAPAs to prevent recurrence.
• May collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
• Technical expert who leads or participates in projects to introduce new products and/or advanced technologies into the plant.

Basic Qualifications:

• Doctorate degree OR
• Master s degree & 3 years of manufacturing and operations experience OR
• Bachelor s degree & 5 years of manufacturing and operations experience OR
• Associate s degree & 10 years of manufacturing and operations experience OR
• High school diploma / GED & 12 years of manufacturing and operations experience

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
• Technical knowledge of drug substance (upstream and/or downstream) processing and broad understanding of related disciplinary areas
• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical areas
• Background in lean manufacturing methodologies and operational excellence