Technical Center, Senior Process Chemist, API

MAJOR RESPONSIBILITIES

. Responsible for API manufacturing process technical support and improvement initiatives for ongoing operations.

. Develops API analytical techniques including HPLC, GC, FTIR, titration and other analytical methods for process

characterization and process mapping.

. Experience in establishing a robust GMP documentation system for data recording including ELN and Empower,

ensuring data integrity and compliance with regulatory standards.

. Acquire knowledge on setting up empower and electronic lab note book

. Designs and executes process improvements and lab studies/experiments

. Serves as a technical SME Provides technical expertise to production and S&T

. Addresses and solves technical problems independently.

. Performs independent, advanced and complex data analysis.

. Generates new ideas and demonstrates a high level of scientific initiative.

. Responsible for continuous process improvement activities.

. Identifies equipment or techniques that improve manufacturing processes and operations.

. Authors technical reports and monitors consistency and quality of technical reports.

JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):

Education

. Bachelor's, Master's in scientific or engineering discipline with 3 to 5+ years of related experience, depending on

degree held.

. Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required

. Demonstrated strong process development skills, including the ability to deliver innovative process chemistry at

scale.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

. Strong record of scientific accomplishment

. Proficiency with Empower software

. Demonstrated record of independent thought and creativity

. Bases technical decisions, within own discipline, on sound engineering or scientific judgment.

. Evaluates and integrates appropriate state-of-the-art technology to improve processes or solve problems.

. Gathers information from multiple sources to assist in problem solving.

. Understands and aligns project goals with business objectives.
Individual who has experience in Active Pharmaceutical Ingredient (API) Manufacturing
Knowledge on setting up GMP lab will be an advantage
This candidate would have a 3 -5 years of working experience.
This is a 6-month contract (a continuously rolling contract)