How will you make an impact?
A Formulation Chemist I in Bio-Formulation organizes and carries out multi-stage production processes to prepare and formulate serum products for use as controls and calibrators in analytical instruments; organizes and carries out production processes to prepare and formulate Clinical Chemistry Reagent products; and monitors the complete process of producing serum and CCR products to assure compliance with specifications and GMP/FDA requirements.
What will you do?
- Calculate raw material volumes required for each batch by referencing amounts necessary to meet manufacturing schedule and product specifications.
- Follow detailed processing documentation, processes base serums, Clinical Chemistry reagents, intermediates and final serum products.
- Plan all intermediates at proper times in the formulation cycle to ensure that all target production dates for final product formulation are met.
- Prepare and inspect equipment for use in chemical and bio-formulations. Set up pumps, filters, tubing connections and mixers.
- Follow prescribed directions to calculate the amount of chemical needed to formulate the volume of the product specified in the production schedule. Weigh and mix chemicals with diluents under controlled conditions.
- Responsible for the cleaning and routine maintenance of all equipment.
- Maintain complete and accurate production records in conformance with GMP and FDA requirements.
- Perform basic laboratory analytical testing.
- Ability to successfully perform a line opening and line closing.
- Input data into a computerized material control system.
- Continuously monitors work area for unsafe conditions and take immediate action to correct unsafe condition(s).
- Responsible for quality of product produced.
- Ability to operate lifting equipment if required.
- Continuously follows all safety requirements including PPE.
- Performs other duties as assigned.
Minimum Requirements/Qualifications:
- High School Diploma or equivalent; a B.S. in Science or Medical Technology is preferred. Minimum of one year production experience (may be waived in lieu of B.S. in Science) and knowledge of the metric system (weights & volumes). Relevant education may be considered in lieu of one year production experience.
Non-Negotiable Hiring Criteria:
- Must have excellent math and communication skills and working knowledge of the metric system (weights & volumes).
- Proven problem solving skills
- Demonstrated ability to organize and prioritize work
- Familiarity with various internal production processes
- Working knowledge of computer applications (MS Office)
- Knowledge of GMP and ISO requirements
- Ability to work effectively with team members at all levels
- Familiarity with SAP transactions is a plus
- Flexible around work hours, available for overtime, as necessary (may include extended shifts & weekends)
- Ability to follow written and oral instructions
- Demonstrated good safety and quality practices
- Good attendance history is required.
Physical Requirements:
- Normal manufacturing environment.
- Position may require frequent communication and walking to other areas in which designated PPE will be required.
- Must be able to successfully complete a Respirator Fit Test within 6 months of hire.
- Position will require sitting and standing.
- Ability to lift materials weighing up to 110 pounds. Employee to employ traditional lift ing techniques for materials up to 75 lbs. Items over 75 lbs will require the employee to use non traditional techniques including, push-pull method, automated lifts and other equipment or additional techniques. Employee will be trained in these techniques upon employment. Employees already in position will require one time training.
This position is not approved for relocation benefits.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Source: Indeed.com
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