Summary: Formulates buffers, media and other aqueous solutions for use in manufacturing processes. Weighs, measures and checks raw materials to assure batches manufactured contain proper ingredients and quantities. Conducts in-process testing, including pH, conductivity, and temperature measurements, as needed in solution preparation. Performs titration of buffers and media as needed. Operates production equipment. Works in clean room environment. Writes, revises and uses records to comply with regulatory requirements, Good Manufacturing Practices and Standard Operating Procedures.
Works on problems of basic scope where analysis of situation or data requires a review of identifiable factors. Follows defined procedures and practices to determine appropriate action. Normally receives general instructions on routine work, detailed instructions on new assignments.
- Adheres to cGMP for all cGMP activities, and documents activities as they occur on the appropriate forms and/or records
- Following batch record, weighs chemical raw materials, dissolves them in water for injection using appropriate mixing techniques, adjusts pH and volume as appropriate, and filters solutions through 0.2 um sterilizing filters into sterile vessels using appropriate aseptic technique.
- Moving heavy volume of liquid daily, of up to 1200 lbs on wheels.
- Performs mathematical calculations relating to solution preparation, including molarity and percent calculations, to determine the quantities (weight or volume) of chemicals needed for a given preparation.
- Writes buffer-batch records and SOP’s related to formulation of solutions.
- May prepare bench-scale quantities of buffers repeatedly to develop data for setting specifications on parameters such as density, pH and conductivity.
- Formulates solutions of active and placebo ingredients as needed for aseptic filling.
- Ensures that routine facility and equipment maintenance is performed in a timely fashion according to the appropriate SOP’s
- Maintenance and calibration of common equipment such as weights and tubing welders
- Cleaning of common equipment such as hoods, mixers, and impellers.
- Updates existing SOP’s and specifications as required.
- Assists in the cleaning of the Manufacturing Facility as required.
- Reviews completed batch records to ensure completeness.
- Identifies and addresses any deviations or excursions in batch documentation and notifies the supervisor as soon as they occur.
- Performs other duties as assigned.
- Exhibits effective written communication in email and GMP documentation.
- Exhibits effective interpersonal skills in dealing with co-workers within the department and in supporting departments.
- Substitutes for or shares responsibility for completing routine assigned tasks of other individuals in the department in their absence.
- Requires a High School diploma with 1-3 years relevant experience or BS in a related discipline or equivalent
- Extensive experience with mammalian cells such as CHO. PERC6, Hybridoma, and NS0. Supervisory experience preferred.
- A solid understanding of scientific principles and techniques used in cell culture for the production of protein therapeutics.
- Ability to read, interpret and author documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Ability to apply complex mathematical concepts to physical problems in areas such as heat and mass transport.
Equivalent combinations of education, training, and relevant work experience may be considered.
- Working knowledge of Microsoft programs Word, Outlook and Excel
- Requires good organizational skills and ability to multitask.
·Able to complete solution formulation tasks, such as component preparation and sterile filtration.
Example - Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to heavy weights of 10-100 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.