Scientist I (Manufacturing Sciences)
How will you make an impact?
The Scientist I, Manufacturing Sciences is responsible for prioritizing assigned projects related to the development and improvement of DNA-based diagnostic reagents with supervision.
What will you do?
Duties and responsibilities include, but are not limited to the following:
- Simultaneously manage and prioritize multiple projects and products across multiple functional groups while meeting target due dates with guidance of Supervisor/Lead
- Design, create experimental task, run tests and complete analysis using uType, SureTyper, Fusion, or equivalent software
- Provide experimental task(s) to designated Scientist with Supervisor approval
- Identify improvements, then initiate and implement the solutions with the guidance of the Supervisor
- Train current and new Scientist I in lab functions/procedures/analysis and provide guidance and support throughout projects and product builds. Processes include reconstitution, quantification, QC test, organization and maintenance of all raw materials such as oligonucleotides, ancillary reagents, genomic DNAs, etc.
- Operate and train Scientists in the use of SAP, UV spectrophotometer, thermal cycler, agarose gel electrophoresis, UV image analyzer, genetic analyzer, qPCR instruments, Luminex instruments, high speed centrifuge and other hardware
- Coordinate and plan the day-to-day tasks to maintain the project(s)/product(s) workflow with guidance from Scientist II/III/Supervisor
- Plan and design experimental methods under supervision to achieve technical objectives as well as identify and solve problems with minimum complexity
- Prepare accurate and timely reports to Scientist II-III/Management.
- Conduct maintenance and organization of reagents and equipment.
- Maintain and perform all aspects of receiving and quality control testing of raw materials.
- Update and maintain raw and semi material inventories, including cycle count activities
- Prepare and QC buffer solutions
- Maintain and update all required SOPs and quality records of equipment maintenance, tests, analyses and other relevant data with the guidance of Scientist II/III/Supervisor
- Implement and execute Practical knowledge of PPI Business System/LEAN concepts including continuous improvement with supervision
- Be able to identify goals, review and update Supervisor throughout the year and complete the PMD
How will you get here?
- Bachelor’s degree in Biological Sciences, Chemistry, Molecular Biology or related field required.
Knowledge, Skills, Abilities
- Knows basic principles, methods and practices of HLA and scientific/technical field or software, typically via formal study and/or work in the field
- Understands industry practices and standards and can relate day-to-day work to business problems
- Recognizes and understands the technologies within the organization and understands the value to the organization
- Knowledge and hands-on experience of molecular biology and recombinant DNA techniques
- Able to complete assigned tasks in a timely manner
- Strong organizational and time management skills, as well as ability to work in a detail-oriented manner
- Ability to exercise decision making with the guidance of Management/Scientist II-III
- Collects and organizes data in an appropriate manner, including documenting all experiments in a laboratory notebook or appropriate documentation
- Ability to use PCs for data input and/or analysis
- Excellent computer MSOffice skills
- Plan and organize oneself in a consistent manner and maintain work schedules
- Be a self-starter with the ability to positively motivate others in a cooperative fashion
- Follow oral and written directions
- Read, understand and implement written laboratory procedures
- Communicate clearly and concisely, orally and in writing
- Builds productive cross-functional relationships with colleagues in other functions, including but not limited to the following: Marketing, Sales, R&D, Operations, Regulatory/Quality, Supply Chain, and Product Management
- Ability to collaborate effectively with all functions of the business
- Encourages/challenges others and self for continuous improvement
- During situations that have high impact to the business, quickly escalate them by bringing solutions and consulting with Supervisor
- Be able to efficiently handle multiple tasks and projects simultaneously
- Develop skills to perform other duties as assigned
- All laboratory personnel are expected to notify their immediate supervisor of any unsafe conditions and/or practices and to take appropriate corrective action. This position will have daily contact with other laboratory personnel.
- Maintain confidentiality of sensitive laboratory and business data
- Ensure that safe laboratory procedures and protocols are followed at all times, especially in the application of universal precautions in handling of all blood and blood products
- Ensure all processes and teams are in adherence of cGMP and GDP
- Ensure compliance with corporate, site, and regulatory policies, practices, and guidelines
- Communicate effectively with members of the group as well as those in other departments
- Work as a cooperative member of a Production team
- Working Conditions/Physical Requirements:
- Frequently work at lab bench, in low temperature freezers and at PC workstations
- Handle blood samples and blood byproducts occasionally
- Some lifting of objects including laboratory instrumentation of 35 pounds