Process Engineer III
Spectraforce
St. Louis, Missouri
2 months ago
Job Description
Job title: Process Engineer III
Duration: 1 Year (Possibility of extension)
Location: St. Louis, MO, 63011 (Role is primarily remote, they will not report onsite daily)
HM Notes:
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 client's 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
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)
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $75.00/hr.
Duration: 1 Year (Possibility of extension)
Location: St. Louis, MO, 63011 (Role is primarily remote, they will not report onsite daily)
| 9-5 EST; 8am-4pm cst |
|---|
HM Notes:
- Manager will consider candidates willing to relocate to St. Louis at their own expense
- Candidates must be willing to visit local CMO. (Location is 5 mins from the airport)
- No other team members are local, manager sits in Framingham, MA
- Free parking onsite, coordinator with CMO
- Possibility for travel to Framingham, MA and reimbursement would be provided
- 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
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 client's 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
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)
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $75.00/hr.