AddressSummary of responsibilities:
Contributes to the support of development, implementation and maintenance of manufacturing methods, techniques, processes, and product. Interfacing as appropriate with Development, Quality, Manufacturing, Purchasing and suppliers. The incumbent assists with coordinating the release of new and enhancements to existing products; participates in design reviews, inspections, and product quality processes; aids the development product structures and ensures manufacturing documents are created, updated and in compliance with company standards, ISO and GMP as required.
Boundary Conditions/Authority Levels: Receives instruction on routine work, instructions on new assignments.
Essential Duties and Responsibilities: include the following. Other duties may be assigned.
- Well versed with Manufacturing/QC/R&D related activities.
- Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Ensures strict adherence to good laboratory and good documentation practices throughout the design and development cycle and design/ technology transfer.
- Applies analytical skills and independent judgment to develop innovative, practical, and consistent solutions to a wide range of complex problems.
- Involve in study planning to align with requirements standards and regulatory requirements and ensures the studies are conducted in agreement with approved plans.
- Flexible to take up new challenges & performs other related duties as required.
- Coordinate with external cross functional team for product transfer (both external transfer and internal transfer)
- Execute smooth Technology Transfer of products from Design and development to Manufacturing.
- Execute Process validations and test method validation should be trained on writing SOP and manufacturing procedures.
- Should perform experiments to control or to manufacture reagents according to procedures, technical protocols in respect of QA and RA regulation and GMP rules.
- Analyze results, solve simple technical issue/problem, and inform in an appropriate ways issues identified.
- Organize tasks by taking into an account priority defined by Team Leader.
- Responsible for follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Contribute to the redaction and the update of experimental reports, procedures, or manufacturing/ QC instructions. should be trained on Protocol writing for SOP and manufacturing procedures.
Education and/or Experience: Hands on experience on protein purification techniques, Hands on Experience with advanced laboratory measurement systems are desired (AKTA, HPLC, Spectrophotometer, Protein estimation techniques, FRET analysis) and various modes of Preparative or Analytical chromatography (Affinity, IEC, MMC, SEC). Experience with Technology transfer, validations, risk assessment. Basic knowledge on Flow cytometry, Immunology basics (Antigen, Antibody, CD Markers etc.) or other immunoassay development techniques preferrable.
Advanced degree in Biotechnology/Biochemistry, for example bachelor’s or master’s degree with 4-7 years’ experience in field.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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