Scientist I/ Chemist - Beach Park, United States - Randstad Life Sciences US

Description

A global leader in the manufacture of cGMP-produced, high purity, injectable grade excipients and bioprocessing solutions. The majority of leading biopharma firms trust us to supply them with critical formulation components for their commercial manufacturing needs

"PERMANENT ROLE" "EXCELLENT TEAM"

KEY SKILLS:

SCALE UP PRODCUTION

PROCESS DEVELOPMENT

API

HPLC

GC

SYNTHETIC CHEMISTRY

SUMMARY

The Scientist I- Process Development / Production Chemist works as part of a scientific team in a synthetic organic chemistry laboratory, with an emphasis on internal development of our clients High Purity Ingredient portfolio and execution of active pharmaceutical ingredient development and manufacturing projects. The primary objective regardless of focus is the development of robust technology transfer dossiers supporting the transfer from the laboratory to pilot and production operations. Provide production and) lab support for research, development, and c-GMP manufacturing. Must be able to work in a complex, fast paced environment with an ability to prioritize. Organization and attention to detail a must to maintain accuracy and quality of work. Must have good written and verbal communications skills

ESSENTIAL DUTIES AND RESPONSIBILITIES

Produce cGMP high quality products that satisfy the Quality, Delivery, and Safety expectation of our biopharmaceutical and pharmaceutical customers

Participate in transfer in our cGMP high potency kilo lab and Pilot Plant manufacturing area

Perform production scale-up activities in support of research and development within our GMP API manufacturing areas

Execution of cGMP production as a production chemist of preclinical -commercial APIs scheduled within our cGMP kilo lab and pilot plant manufacturing suites

Conduct, as needed, laboratory chemistry experimentation in support of process development under the direction of a Senior Scientist from Process Development.

Support technology transfer to scale-up facility by providing shift technical coverage where applicable

Participate on project teams directed toward the development of active pharmaceutical ingredients and high purity ingredients

Ensure scientific integrity and quality of laboratory work they perform and review

Prepare and / or review technical reports and standard operating procedures

Communicate project status and problems encountered to management

Ensure accurate documentation and work in compliance with standard operating and safety procedures

Perform peer review of data for other staff members

Ensure adherence to site EH&S, GMP and general and laboratory and plant safety guidelines

Other duties as assigned
QUALIFICATIONS

BA or BS in Chemistry, Chemical Engineering or applicable life science degree and 0-5+ years industrial laboratory experience related to process chemical development and/or small scale GMP manufacturing. Degreed scientist in an alternative life science field will be considered. Recent graduates with limited experience will be considered.

Willing to work flexible shift schedule to support manufacturing requirements

Familiarity with modern analytical methodologies utilized routinely in support of work, including HPLC and GC technique is a plus.

Compliance with cGMP regulations as applied to process development, optimization, production and engineering

Ability to exercise independent intellectual judgment based on specialized skills in the field of science

Organized and detail oriented for accuracy and quality of work in accordance with established procedures

Good written and verbal communications skills

Effective communication with manager and team members

Experience with the production of carbohydrates, amino acids and highly potent API's is desirable
Physical Requirements

Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant

Must be able to sit and/or stand for extended periods

Ability to work effectively under pressure to meet deadlines

Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening

Must be able to lift 25 lbs. or occasionally lift up to 35 lbs.

Ability to wear proper safety equipment when working in the laboratory or plant

US Citizens or Green card holders only