ACS group has an immediate need for a "Associate Scientist" with experience in the Pharmaceutical Industry. This is a 12- month contract opportunity in Devens, MA. Our client is a leading pharmaceutical company.
Please review the job description below:
Top Skills:
Key Requirements and Technology Experience:
The successful candidate will be a key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical and Global Regulatory Sciences groups. Strong communication, presenting, and technical writing skills are required. The incumbent will lead the design and execution of experiments for design & control of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations. Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
- Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings.
- Demonstrates a strong knowledge of cGMP compliance, Client's corporate, site and regulatory agency requirements and procedures
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client's Devens Single Use Facility.
- Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process
- Participates in the preparation of regulatory filing documents and inspection readiness
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site
- Conducts experimentation and analysis to implement new process analytical technology for continual improvement of manufacturing processes
- Supports general laboratory functions and upkeep including cell culture seed trains, bioreactor setup/sampling, data logging, analytics support, lab hygiene and safety updates.
Qualifications:
- B.S,or M.S. in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
- Experience in contributing to the design, modification and optimization of cell culture unit operations
- Proactively identifies problems and troubleshoots solutions
- Organizes and presents data for internal/external scientific meetings
- Works independently, in teams and collaborates with other groups in a matrix environment
- Leverages emerging trends in biotechnology to solve complex problems
- Capable and willing to train others on procedures, operations, new technology, methods or processes
Additional plus (optional)
- Proficiency in statistical methods
- Experience managing large datasets
- Interest in data management infrastructure
- 5S Experience
Thanks & Regards
Parag PATEL
Team Recruitment
P: (+1)
678 487 8366
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
Recent Awards and Recognitions:
IT and Industry certifications:
Technical Writings
Data Analysis
Data Management
Certified Global Meeting Planner
Process Improvements (Business)
Please review the job description below:
Top Skills:
- Bioreactor
- Upstream
- Process Development
- Cell Culture
- Data Analysis
Key Requirements and Technology Experience:
The successful candidate will be a key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical and Global Regulatory Sciences groups. Strong communication, presenting, and technical writing skills are required. The incumbent will lead the design and execution of experiments for design & control of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations. Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
- Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings.
- Demonstrates a strong knowledge of cGMP compliance, Client's corporate, site and regulatory agency requirements and procedures
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client's Devens Single Use Facility.
- Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process
- Participates in the preparation of regulatory filing documents and inspection readiness
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site
- Conducts experimentation and analysis to implement new process analytical technology for continual improvement of manufacturing processes
- Supports general laboratory functions and upkeep including cell culture seed trains, bioreactor setup/sampling, data logging, analytics support, lab hygiene and safety updates.
Qualifications:
- B.S,or M.S. in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
- Experience in contributing to the design, modification and optimization of cell culture unit operations
- Proactively identifies problems and troubleshoots solutions
- Organizes and presents data for internal/external scientific meetings
- Works independently, in teams and collaborates with other groups in a matrix environment
- Leverages emerging trends in biotechnology to solve complex problems
- Capable and willing to train others on procedures, operations, new technology, methods or processes
Additional plus (optional)
- Proficiency in statistical methods
- Experience managing large datasets
- Interest in data management infrastructure
- 5S Experience
Thanks & Regards
Parag PATEL
Team Recruitment
P: (+1)
678 487 8366
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
- Analysts international Corporation (Staff Augmentation Services)
- The Ascent Services Group Inc. (Life Sciences Talent Solutions)
- HireGenics, (Payrolling, IC Compliance, & MSP Services)
- DATA Inc. (Information Technology- staffing)
Recent Awards and Recognitions:
- 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
- Largest Minority IT Staffing Firm in the US. (SIA 2019)
- ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.
IT and Industry certifications:
- Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
- AWS Managed Services Partner
- Google Cloud Partner
- ISO 27001:2013 Certified for Data Security
- ISTQB Gold Partner
- ISMS (ISO 27001:2017)
- SOC2 Type II Compliant
Recommended Skills
DocumentationTechnical Writings
Data Analysis
Data Management
Certified Global Meeting Planner
Process Improvements (Business)