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Process Development Chemist

4 months ago


San Diego, California, United States GTT, LLC Full time
Process Development Chemist
Contract Duration 6 Months
Pay rate up to $28.50/hr

Job Summary:


Process Development Chemist is responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.

Provides oligo process support to the Operations group through instrument/oligo process troubleshooting and completion of Client investigations.
Responsible for research, development, and production manufacturing activities associated with oligos.

Essential Duties and Responsibilities:


The Process Development Chemist may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

Independently produces notebook, dev, pilot, and production materials per written directions
Analyzes in-process and final oligos using state-of-the-art analytical techniques
Troubleshoots simple manufacturing process problems
Analyzes process data
Creates documents and assists with the assembly of change control packages
Maintains labs under cGMP conditions
Completes ERP and cycle count transactions
Keeps accurate records and documentation
Stocks and maintains lab supplies.

Summary of Duties and Responsibilities:
Independently produces notebook, dev, pilot, and production materials per written directions
Analyzes in-process and final oligos using state-of-the-art analytical techniques
Troubleshoots simple manufacturing process problems
Analyzes process data
Creates documents and assists with the assembly of change control packages
Maintains labs under cGMP conditions
Completes ERP and cycle count transactions
Keeps accurate records and documentation
Stocks and maintains lab supplies.

Physical Demands:


The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Sit; use hands to finger, handle, or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Exposure to moving mechanical parts, vibration, and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Safety Shoes with Impact and Compression Protection Must be worn.
Exposure to blood.

Job Qualifications:

Required Education:
Typically requires a Bachelor of Science degree or equivalent and a minimum of 0-2 years related experience.

Required Experience:
Working knowledge of QSR/GMP
Proficiency with MS Word and Excel
Strong math skills
Basic EDMS change control skills and ERP knowledge
Working knowledge of oligo synthesis, purification, desalting, and diafiltration processes
Working knowledge of analytical chemistry specific to oligos. (Maldi MS, HPLC, OD, etc.)

Required Skills:
Analytical
Communication
Teamwork
Learning
Initiative
Problem-Solving
Interpersonal skills

Technology Requirements:
(I.E Programs, systems, etc)
Basic Anion Exchange or Reverse Phase Chromatography knowledge/experience
DNA synthesis knowledge/experience

Daily Tasks:
6 Hrs in lab manufacturing.
Follow GMP/GDP practices.
Manage inventory and keep stock of materials.
Daily cleaning of assigned lab areas.

Preferred background/prior work experience:
Not required but prefer candidates with a basic understanding of various purification methods and basic chemistry understanding.

Priority soft skills:
Word and Excel.
Good communication.

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About The Company:
Our client is an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.

While they Clients and develop groundbreaking products and services that benefit everyone, they are especially passionate about those that advance women's health and well-being.

This allows us to be a company that prospers, grows, and empowers women to experience healthier lives.

What powers their growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates them: the exceptional and clinically proven ability of their products to detect, diagnose, and treat illnesses and other health conditions earlier and better.

None of this would be possible without the talent, skills, and aspirations of their employees.

Their proficiency and commitment to develop and share more robust, science-based certainty drives the company's increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families, and communities.