Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.
Position: Scientist I - Manufacturing Sciences
Location: Plainville MA 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Plainville MA 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday To Friday From 08:00 AM To 05:00 PM
Summary
This role focuses on Technology Transfer and Process Development for injectable and sterile pharmaceutical products, supporting projects from early process development through commercial scale-up and validation. The position works closely with Formulation, Filling, and Freeze Drying operations to develop, transfer, optimize, and troubleshoot manufacturing processes. The individual will support client technology transfers, process development studies, scale-up activities, process validation, manufacturing support, investigations, and change controls. The role also involves analyzing process data, developing technical solutions, preparing GMP documentation, and communicating technical findings with internal teams and clients.
Responsibilities
- Complete technology transfer activities, process development studies, commercial scale-up, and process validation support.
- Perform manufacturing process development for injectable products transitioning to commercial manufacturing lines.
- Use experimental design to establish formulation processes, product pathways, and component selection for successful scale-up.
- Provide technical support to daily operations in Formulation, Filling, and Freeze Drying areas.
- Develop and implement technical/scientific strategies and solutions for processes, products, and projects.
- Assist in creating processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches.
- Support technology transfer of projects from clients.
- Support client calls and provide project updates and scientific justification.
- Prepare documentation including work orders, protocols, reports, summaries, memos, and forms with minimal supervision.
- Represent the organization during internal technical discussions.
- Participate in problem-solving activities related to formulations, equipment, and manufacturing processes.
- Support projects with moderate supervision while maintaining timelines and project goals.
- Implement change control actions and review technical aspects of projects.
- Support manufacturing operations, change controls, and investigations as a Subject Matter Expert (SME).
- Collect data for statistical analysis and support interpretation and summarization of results.
- Contribute to project results and technical solutions.
Required Skills
- Bachelor of Science in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related physical science, plus 1+ year of related experience; or a related Master's degree.
- Strong knowledge of scientific methodology and pharmaceutical process development.
- Detailed knowledge of Good Manufacturing Practices (GMP).
- Technical expertise in upstream/downstream biopharmaceutical manufacturing and/or process development.
- Prior experience with technology transfer or process validation.
- Experience in a CDMO or pharmaceutical product development environment preferred.
- Strong written, interpersonal, and presentation skills.
- Ability to lead or participate in technical discussions with internal teams and external clients.
- Strong problem-solving and decision-making abilities.
- Ability to manage multiple projects simultaneously.
- Ability to learn pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to stay current with scientific literature and industry trends related to process technologies.
- Ability to develop and implement technical solutions.
- Ability to collect, analyze, interpret, and summarize process data.
- Ability to work effectively in GMP manufacturing and laboratory environments.
- Ability to stand and walk as required and lift/carry objects up to 25 lbs. for brief periods.
- Ability to use required PPE during manufacturing activities, client visits, or facility tours.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Plainville, MA |
| Industry | Computer/IT Services |
| Salary | $28–$30 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Analysis Skillsunmatched
- Assembly Lineunmatched
- Biochemistryunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Chemistryunmatched
- Component Selectionunmatched
- Customer Support/Serviceunmatched
- Data Analysisunmatched
- Data Collectionunmatched
- Data Processingunmatched
- Documentationunmatched
- Drug Developmentunmatched
- Experiment Designunmatched
- GMP (Good Manufacturing Practices)unmatched
- Healthcareunmatched
- Identify Issuesunmatched
- Industry/Trade Analysisunmatched
- Instrumentationunmatched
- Interpersonal Skillsunmatched
- Laboratory Equipmentunmatched
- Leadershipunmatched
- Lift/Move 25 Poundsunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Manufacturing/Industrial Processesunmatched
- Material Movingunmatched
- Multitaskingunmatched
- Operational Supportunmatched
- Operationsunmatched
- Physical Scienceunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Analysisunmatched
- Process Developmentunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Product Developmentunmatched
- Product Supportunmatched
- Project/Program Managementunmatched
- Purchasing/Procurementunmatched
- Scientific Methodunmatched
- Scientific Researchunmatched
- Statisticsunmatched
- Technical Deliveryunmatched
- Technical Strategyunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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