Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
- Perform and oversee production and production support duties for Operations and ensure quality of production and lab testing processed by the department.
- Performs a variety of duties relating to production and testing operations. Follows departmental work instructions, SOP’s, OSHA safety regulations and cGMPs to perform assigned tasks.
- Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
- Duties may include handling of hazardous materials in activities described above. Depending upon area of assignment or primary focus, may maintain departmental stock rooms, keep labs stocked, prepare buffers as needed/required which may also include performing direct production or testing activities.
- Monitor lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
- Duties may include handling of hazardous materials as described above. Depending upon area of assignment or primary focus, may perform various manufacturing and testing duties in addition to maintaining departmental stock rooms, log books, preparing buffers as needed/required which may also include, performing direct manufacturing activities such as bulk formulation, filling, sub-assembly and sample testing.
- Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.
- Attends required training classes and participates in on-the-job training.
- Manages schedules, workload and establishes priorities using inputs from business requirements, SAP, and/or internal customer needs.
- Participates in the design and organization of experiments in conjunction with supervisor. Providing input in writing experimental protocols, investigations and reports may be required. Serves as a resource to operations or scientific staff.
- Provides input for improving existing laboratory procedures. Assist supervisor in development and implementation of new procedures and evaluating new products and equipment. Assist with generation of written standard operating procedures.
- Other duties as assigned by management.
- Purifying proteins (specifically enzymes) and manufacturing the required reagents by following detailed instructions outlined in production batch records and standard operating procedures (SOPs).
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Required: Associate's Degree equivalent combination of education and work experience.
Preferred: Bachelor's Degree
Required: Years of Experience: 2 - 4 years of relevant experience.
Preferred: Experience working with cell material, HPLC, tangential flow filtration (TFF) is preferred.
Are equivalencies acceptable?
Knowledge, Skills and Abilities
- Basic proficiency with MS Word and Excel; Excellent Written and Verbal Communication Skills.
Based on business needs