System Specialist/Sr. System Specialist, Solid Dose Operator

Company: Genentech
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

The successful candidate will have expertise with Oral Solid Dosage unit operations such as blending, milling, drying, roller compaction, wet granulation, tablet compression and tablet film coating. The individual will assist Formulation Development Scientists Researchers in the laboratory to set up small-scale equipment for manufacturing solid dose formulations and also for cleaning-up the equipment post processing in both Development and GMP suites. The individual will regularly utilize isolator technology to handle potent compounds and must adhere strictly to existing procedures and safety guidelines. The individual will also perform routine testing on solid dosage forms such as tablet hardness, friability, particle size analysis, flow and density, as well as novel testing methods as necessary.

The candidate will possess computer skills sufficient to write operating procedures, maintain laboratory supplies, and review/print batch records and labels. Familiarity with spreadsheet software (e.g., Microsoft Excel or Google Sheets) is a required competency. Experience with other data analysis software (e.g., JMP, Minitab, etc) is preferred.

Candidate must have excellent skills in communication, organization, flexibility and an eagerness to learn. The candidate will engage with vendors for handling ad execution of small projects and coordinate activities related to our operation. The Position will also require to maintain inventory of our raw material in the GMP and non-GMP areas. Familiarity with SAP and the material transfer related transactions is desired for this position. In addition, the candidate will be responsible for coordinating and executing surrogate testing activities among other Development and GMP labs readiness activities. Must work well with others and be a team player. Must be capable of standing, kneeling, bending, etc., for extended periods of time, must be able to lift and carry up to twenty-five (25) pounds, and must be willing to work with potentially hazardous materials, adhering to health and safety guidelines. Must demonstrate working knowledge (post-training) of GMP requirements and adhere to existing procedures.

Education: Relevant engineering and science degree with not less than 3 years of experience or more than 5 years of experience in regulated pharmaceutical manufacturing operations.

Preferred Qualifications:

In addition to basic qualifications, a successful candidate must have experience working in GMP environment and is proficient in preparation of GMP related documentations, including SOPs, batch records, and change records. The individual should have experience in operating small molecule unit operation equipment, including roller compaction, high shear wet granulation, milling, blending, tableting, and film coating. Experience working with isolator technology or high-potency compounds is highly desired.

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Keywords: Genentech, South San Francisco , System Specialist/Sr. System Specialist, Solid Dose Operator, Other , South San Francisco, California