Process Engineer

Description

Role is primarily remote, they will not report onsite daily.

• Candidates must be local to the St. Louis, MO area and willing to visit local CMO.
• Free parking onsite, coordinator with CMO
• Possibility for travel to Framingham, MA and reimbursement would be provided
• Possibility of extension.

Must Have:

• Direct (hands-on) lab experience in biologics development would be good experience.
• Technical supporting role of commercial biologics processes.
• This would include activities like root cause investigation, process validation, lifecycle manage, and/or process trending.
• All of this would be done in alignment with GMP practices.
• Process validation & Root cause analysis and/or risk assessment experience
• Bachelor’s degree in engineering or science with 5 years of experience in Process Engineer or related role at Pharm/ Biotech Company OR master’s degree in engineering or science with 3 years’ experience in Process Engineer or related role at Pharm/ Biotech Company
• PhD candidates welcome if min of 3 years of experience as mentioned above

Nice to Have

• Prior experience in a technical role supporting a GMP, MSAT or commercial processes,
• Experience with equipment qualification

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 Client 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)