Manufacturing Scientist Resume
Headline : As a Manufacturing Scientist, responsible for representing operations, establishing new processes, arranging necessary resources, and creating documents to successfully transfer products from R&D/Development or other manufacturing sites to Vilnius manufacturing groups.
Skills : Technical Proficiency, Problem-Solving.
Description :
- Acted as operation representative in NPI (New Product Introduction) projects.
- Transferred products to manufacturing from other Scientific manufacturing sites to the Vilnius site.
- Created technical, manufacturing, and validation documentation.
- Responded to queries received via email from clients or colleagues.
- Initiated and led major change procedures.
- Acted as a project manager and trained new staff members.
- Worked under ISO: 13485, GMP, and GLP manufacturing processes, practices, and procedures to convert raw materials to finished products.
Experience
5-7 Years
Level
Executive
Education
B.S. in Chemistry
Manufacturing Scientist Resume
Objective : As a Manufacturing Scientist, work as an integral member of the operations team contributing to the production of the MDxs suite of CE IVD products.
Skills : Quality Assurance, Data Analysis.
Description :
- Contributed to the development, maintenance, and compliance of the MDx’s manufacturing process.
- Executed all aspects of product manufacturing as per MDx’s established SOPs.
- Contributed to the generation of batch traceability data and reporting.
- Acted as an internal auditor of MDx products, processes, and systems.
- Organized tasks by taking into account priority defined by the Team Leader.
- Contributed to the day-to-day maintenance of the MDx manufacturing facility, including equipment performance maintenance and validation activities.
- Worked as a cross-functional member of the wider MDx team about all manufacturing aspects.
Experience
2-5 Years
Level
Executive
Education
B.S. in Industrial Engineering
Junior Manufacturing Scientist Resume
Objective : As a Junior Manufacturing Scientist, responsible for a variety of tasks, from conducting research and experiments to developing and testing new methods and technologies, analyzing data and results, and communicating their findings and recommendations to engineers, managers, and clients.
Skills : Teamwork and Collaboration, Attention to Detail.
Description :
- Executed technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, purity, and/or productivity.
- Provided technical support for the preparation of relevant technical documents, as required, such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, and VMPs.
- Developed and monitored established metrics in real-time to assess process variability and capability.
- Understood, justified, and documented the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Ensured that an accurate instruction set (tickets & procedures) and PFD described the process as performed and the control strategy for the discrete manufacturing steps.
- Provided support to internal and joint process teams and the global and local PLOT teams.
- Able to independently set up and execute various chemical reactions.
Experience
2-5 Years
Level
Junior
Education
B.Pharm
Senior Manufacturing Scientist Resume
Summary : As a Senior Manufacturing Scientist, collaborate with internal development and/or manufacturing operation teams and provide results to internal teams and clients.
Skills : Project Management, Continuous Improvement.
Description :
- Understood the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Ensured that experiments are well designed with clear objectives.
- Able to analyze data and ensure appropriate documentation.
- Utilized safe laboratory practice and adhered to CHP requirements.
- Solved problems related to the processing of chemical procedures.
- Performed daily instrument calibrations/verifications as required and weekly/monthly inspection of safety equipment.
- Able to read, analyze, and interpret technical procedures and governmental regulations.
Experience
7-10 Years
Level
Senior
Education
B.S. in Industrial Engineering
Manufacturing Scientist Resume
Headline : As a Manufacturing Scientist, perform analytical methods for testing raw materials, samples, stability, production intermediates, and active pharmaceutical ingredients, including method development and qualification activities to ensure that products meet our high-quality standards.
Skills : Safety Consciousness, Adaptability.
Description :
- Conducted routine and non-routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and pharmaceutical ingredient samples by internally developed and compendium test methods.
- Executed developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trained other employees on these techniques.
- Provided thoughtful technical review of data collected by other employees.
- Recognized and reported/investigated out-of-specification or unexpected results and non-routine analytical and product problems.
- Communicated the results of work by documenting the testing/analysis and acquired results; recorded and reported results of analysis by prescribed lab procedures and systems.
- Assisted in preparing regulatory documents and other communications with outside agencies, clients, and colleagues from other corporate sites.
- Wrote and reviewed Analytical Methods, validation protocols, validation reports, and SOPs as needed.
Experience
5-7 Years
Level
Consultant
Education
B.Pharm
Manufacturing Scientist Resume
Summary : As a Manufacturing Scientist, perform activities to support GMS lab operations including sample and data management, reagents and consumables management, buffer/solution preparation, equipment maintenance, author work instructions, and maintaining a safe workspace.
Skills : Organizational skills , Analytical skills.
Description :
- Executed and documented cell culture experiments in the GMS laboratory to support tech transfer, manufacturing investigations, and process improvement projects.
- Analyzed lab study samples and data, the author reports to document study outcomes, and communicated study results to management and project teams.
- Worked within cross-functional teams to support manufacturing scale projects (TT, process investigations, and CAPA or change control implementation).
- Authored investigation protocols and reports, validation protocols and reports, and sample plans as required.
- Familiarized with company's combination product development process (Device Manufacturing, BIologics) and innovation process.
- Consolidated comprehensive overviews of current control strategies for devices (end-to-end).
- Identified opportunities for integrated quality in the device assembly process.
Experience
10+ Years
Level
Management
Education
B.S. in Chemistry
Manufacturing Scientist Resume
Objective : As a Manufacturing Scientist, responsible for generating and maintaining detailed documentation of manufacturing processes, including batch records, standard operating procedures (SOPs), and technical reports.
Skills : Creativity, Observational skills.
Description :
- Collaborated with cross-functional teams from development to commercial.
- Developed business cases and road maps for integrated quality in the device assembly process.
- Performed risk assessments for integrated quality in the device assembly process.
- Provided technical and operational expertise for the delivery of upstream and downstream projects.
- Supported process scale-up and material supply delivery.
- Ensured and drove compliance in all safety and quality aspects of process development activities.
- Designed, planned, executed, and evaluated laboratory studies through hands-on experimentation.
- Undertook manufacturing activities as directed, using the company’s processes safely to meet batch production requirements.
Experience
0-2 Years
Level
Fresher
Education
B.S. in Industrial Engineering
Manufacturing Scientist Resume
Objective : As a Manufacturing Scientist, responsible for providing training and guidance to manufacturing personnel on operating procedures, equipment use, safety protocols, and quality standards.
Skills : Collaborative skills, Communication.
Description :
- Drove continuous improvement activities through innovation and shared technical knowledge across the network.
- Supported the commercial manufacturing process of designated products.
- Supported the technical transfer of DP processes into CMOs from TD to CMO, and/or from CMO to CMO.
- Executed Process Validation Runs, (review, approval, and execution of process validation activities).
- Supported commercial manufacturing activities at CMOs (continuous process verification, APRs manufacturing technical documentation).
- Led drug product manufacturing investigations (oral dosage forms), root cause analysis, and identification of process-related CAPAs.
- Accessed and implemented manufacturing process changes to existing commercial processes including CAPAS and performed document risk assessment.
Experience
2-5 Years
Level
Executive
Education
B.Pharm
Manufacturing Scientist Resume
Summary : As a Manufacturing Scientist, responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
Skills : Problem-solving skills and logical approach to solving scientific problems.
Description :
- Designed, executed, and analyzed technical studies and to support the Technical Product Lead.
- Reviewed process trends, to identify anomalies and implemented corrective actions.
- Contributed to the writing of regulatory documentation, filings, briefing books, and RTQs.
- Operated various equipment involved in the manufacturing and testing of products, at various batch scales.
- Completed all documentation accurately in full to support clinical manufacturing activities including logbooks, batch records, and log cards.
- Managed and maintained equipment and the manufacturing facility, including cleaning duties.
- Managed receipt and booking of raw materials.
Experience
10+ Years
Level
Management
Education
B.S. in Industrial Engineering
Manufacturing Scientist Resume
Summary : As a Manufacturing Scientist, responsible for following all company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition.
Skills : Excellent interpersonal, and presentation skills.
Description :
- Worked and adhered to the Quality Management System.
- Followed standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Ensured strict adherence to good laboratory and documentation practices throughout the design and development cycle.
- Involved in study planning to align with requirements standards and regulatory requirements and ensured the studies were conducted in agreement with approved plans.
- Coordinated with the external technical team for product transfer (both external transfer and internal transfer).
- Executed smooth Technology Transfer of products from design and development to Manufacturing.
- Analyzed results, solved simple technical issues/problems, and informed in appropriate ways issues identified.
Experience
7-10 Years
Level
Senior
Education
B.S. in Chemistry
