Scientist, Process Development

General Responsibilities: (A brief description of the overall job.)

 

Conduct process development studies, scale-up and manufacture GMP clinical/pivotal batches; generate reports, write batch records and SOPs; must be able to work ?hands-on? with pharmaceutical unit operations; set up, operate and clean equipment.

 

Key Responsibilities: (Give a brief summary of the important duties and responsibilities in order of importance.)

 

? Conduct process scale-up /optimization experiments   

? Generate reports/compile data   

? Write batch record/SOP

? Interface with Clinical/Toxicology Department for trials and study designs

? Clean equipment

? Respond to QA Audits/write deviations/incident reports   

? Obtain/maintain training on GMP/safety procedures

? Work with tech transfer and manufacturing personnel to transfer products 

 

Position Specifications: (Describe the minimum, reasonable, essential knowledge and training you believe to be necessary to allow a person to either perform or learn to perform independently and with average proficiency in the job.)

 College degree in Chemistry, Pharmacy, Engineering or similar discipline and experience in Pharmaceutical industry, cGMP environment:

? Good understanding of cGMP and regulatory guidelines

? Good Communication skills.

? Good technical writing skills.

? Excellent organizational skills.

 

-  Knowledge and Technical Skills:

Basic computer skills ? word processing and spreadsheets. Experimental Design and hands-on experience with equipment/machines (demonstrating) mechanical ability is a plus.

 

-  Language Skills:

Good written and verbal communication skills are necessary because the position calls for SOP/Batch records/report writing.

 

-  Mathematical Skills:

Math skills are a definite requirement: the position calls for doing formulation calculations, capacity calculations and mass balance estimates, carrying out in-process analytical measurements. Familiarity with scientific and/or engineering units is mandatory.

 

-  Reasoning Ability:

This position calls for analyzing data and making informed decisions based on product/process performance; hence, reasoning ability is key in providing diagnoses and /or analyses.

 

-  Other Skills and Abilities:

A mechanical aptitude/ an ability to work with moderately complex machinery is a must; time-management skills are also necessary.  Team player ? enthusiastic, hard working and dependable.  Flexible in work hours.