General Position Summary
Responsible for production activities including bulk formulations, filling and packaging final goods, as well as preparing and reviewing batch production records. These products include immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), and immunochemical materials.
Essential Job Functions
- Manufactures FISH and CISH probes, CISH detection systems, and other ISH reagents.
- Manufactures primary antibodies, detection systems, and other IHC reagents.
- Performs cell culture, antibody purifications, and conjugations.
- Performs dilutions and calculations for bulk product formulations.
- Assists with transfer of new products into production after product approval.
- Maintains raw materials and intermediate inventories; creates Purchase Requisitions when material is low in inventory.
- Completes and reviews production batch records and validation documents.
- Drafts receiving records, MSDS, and specification sheets.
- Communicates with Order Management team to process orders.
Technical Operations Activities
- Cleans lab area and biosafety cabinets; maintains production equipment and facilities in clean working condition.
- Monitors various production equipment parameters and performs preventive maintenance to ensure proper operation.
- Makes detailed observations and analyzes data; maintains thorough records and training files.
- Creates SOPs and other records for new processes and equipment; updates procedures and records when necessary.
- 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 production 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.
- Assists other departments and performs all other duties as assigned.
- BS or BA degree in Biological Sciences, Biochemistry, or the Life Sciences, or equivalent combination of education and experience.
Experience & Minimum Qualifications
- 3 - 5 years of related experience or equivalent combination of education and experience.
- Previous GMP/GLP experience.
- Ability to work independently and effectively troubleshoot.
- Ability to adapt to change and effectively under pressure and time constraints, while maintaining a high level of work quality.
- Effective communication skills; ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- 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, corporate management team, company affiliates and vendors.
Physical Requirements & Working Environment
- Ability to lift 50 lbs. with assistance.
- Ability to work with products derived from animal plasma/serum.
- This position frequently works 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.
Affirmative Action Employer
Equal Opportunity Employer