General Position Summary
Contributes to the development and improvement of reagents for staining pathology tissues by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and chromogenic in situ hybridization (CISH) on an automated staining platform. Analyzes raw and in-process materials and final products utilizing IHC, FISH, CISH, and PCR, as well as molecular/biochemical and multiplex bead assays. Responsible for the analysis of test results and for following all SOPs and safety guidelines while producing quality test results. Applies basic laboratory techniques and skills to conduct pre-designed experiments, making detailed observations and analyzing data with a high level of accuracy. Prepares technical summaries and protocols for internal use.
Essential Job Functions
Research and Development Activities
- Under supervision, develops and improves FISH and CISH probes, CISH detection systems, and other ISH reagents.
- Under supervision, develops and improves primary antibodies, detection systems, and other IHC reagents.
- With training, performs bacterial culture, glycerol stock production, DNA/RNA extraction and purification, restriction enzyme digestion, PCR, probe labeling, and gel electrophoresis.
- With training, performs cell culture, antibody purification, and conjugations.
- With training, performs blast search, genome browser, PCR printer design, and DNA sequence alignments.
- With training, conducts DNA/RNA probe testing and antibody testing during different development stages.
- Drafts product technical reports.
- Assists with product transfers to production after product approval.
- Conducts experiments using laboratory equipment and appropriate calculations.
Technical Operations Activities
- Analyzes raw and in-process materials and finalized products using IHC, ISH, ELISA, and molecular/biochemical techniques.
- Analyzes and interprets test results according to established quality control guidelines.
- Maintains laboratory instruments and facilities in good working condition.
- Makes detailed observations and analyzes data; maintains thorough records and training files.
- Plans and performs short and long-term stability testing.
- Performs studies to validate changes in materials, formulations, and processes.
- Executes and completes validation reports for processes and test equipment.
- Notifies management of any and all issues that may affect product quality or accuracy and usefulness of data.
Information Management & Reporting Activities
- Performs data analysis.
- Provides feedback by preparing charts, graphs, reports, and other methods of communication as to the status of reagent development activities.
Quality/Business Systems Activities
- Ensures that the Quality/Business System is understood and deployed in area of responsibility.
- Actively seeks opportunities to continuously improve.
- Ensures applicable standards and systems implementation for ISO and FDA QSR’s are met.
- Ensures compliance with all applicable environmental, health, and safety regulations.
- Assists other departments and performs all other duties as assigned.
- Interacts with supervisor and team members in a professional and proactive manner.
- BS/BA or MS/MA degree in Chemistry, Biochemistry, or the Life Sciences, or equivalent combination of education and experience.
Experience & Minimum Qualifications
- 0 – 2 years of related experience or equivalent combination of education and experience.
- Previous GMP/GLP experience.
- Good verbal and written communication skills, with demonstrable competency in technical writing.
- Knowledge in the biological sciences and the scientific method.
- Eagerness to learn and acquire new skills.
- Basic computer and clerical skills.
- Ability to adapt to change and effectively under pressure and time constraints, while maintaining a high level of work quality.
- Excellent mathematical skills; ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.
- Knowledge of biochemical processes, including spectrophotometry, bacterial culture, chromatography, PCR, probe and in situ hybridization, antibodies and IHC, mammalian cell culture, DNA and RNA, cell blocks.
- Ability to effectively interact with diverse personalities; must be tactful and flexible.
- Possesses excellent communication skills with department personnel.
- Ability to use standard office, testing and inspection equipment.
Physical Requirements & Working Environment
- Ability to lift 50 lbs. with assistance.
- Ability to work with human plasma-based products.
- This position may work in a laboratory environment or clean room, and can require wearing a full gown and dust mask.
- Ability to read and analyze information in both hard copy and on-screen forms.
- Ability to successfully respond to multiple work pressures.
- Ability to listen, resolve problems, and manage tasks.
- Ability to effectively communicate verbally and in writing to individuals and groups.
- This position requires the employee to frequently sit; in addition, the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.
Equal Opportunity Employer
Affirmative Action Employer