Job Description

Job Description

Job Description

Company : Large Pharmaceutical Company

Title : Process Engineer III

Contract Position : 1 year with potential extension

Type of work : Role is primarily remote, contractor will not report onsite daily.

Location : 6244 Lemay Ferry Rd, St. Louis, MO

Description :

Please note location: St. Louis, MO
DEPARTMENT DESCRIPTIONS
The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.
Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

KEY RESPONSIBILITIES
The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group support commercial operations across a diverse network of manufacturing facilities and external partners. Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
• Reviews manufacturing processes, deviations, and/or development and production data.
• Reviews manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
• Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
• Bachelor’s degree in engineering or science with 5 years of experience
OR
• Master’s degree in engineering or science with 3 years of experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

LEADERSHIP QUALIFICATIONS

N/A

PREFERRED QUALIFICATIONS
• Experience with Good Manufacturing Practices and supporting a commercial facility
• Experience in cell culture and/or downstream purification (direct lab experience a plus)
• Experience with equipment qualification and process validation
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• Experience communicating with cross functional teams
• Strong technical writing and communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint

SPECIAL WORKING CONDITIONS
• Ability to gown and gain entry to manufacturing areas
• Ability to travel (up to 20% of time) Company Description

Company Description

Job Tags

Contract work, For contractors, Remote job,

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