Associate Manufacturing Scientist
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Job Description
The Position
This position will involve assisting in the synthesis and subsequent purification steps of large scale oligonucleotides. The operator must comply with GLP/GMP protocols and be able to follow all association SOPs and work instructions when performing and documenting operations.
Responsibilities
Prepare batch records, SOPs, and work instructions to detail
Document alloperations in batch records and notebooks
Experience in investigating and closing deviations
Ability to identify, design, and implement process improvements
Comply with GMP protocols
Operate large scale oligonucleotide manufacturing equipment (i.e. oligonucleotide synthesizer, purification skid, tangential flow filtration system, lyophilizer, ChemGlass reactors, pH/conductivity meters, peristaltic pumps, )
Lead and provide support to other chemists within the CMC group during synthesis and purification of oligonucleotides including:
Reagent solution preparation
Mobile phase preparation
Column Packing
Fraction collection
Develop and optimize test methods for oligonucleotide/intermediate analysis via LCMS
Assist in scale up/process development from small/mid-scale chemistry
Contact vendors for purchasing manufacturing equipment/performing routine maintenance and repair, and assist with FATs for equipment as needed
Maintain a clean work space
Maintain safety by wearing required personal protective equipment
Maintain safety by wearing required personal protective equipment
Track and update raw material usage in D365 ERP software
Act as production campaign lead
Assist with new personnel training
Address and resolve production challenges proactively, utilizing analytical and critical thinking skills
Requirements:
- Bachelors degree in a scientific field
- 5-10 years experience in a similar position
- Experience working in a GMP setting and controlled documentation
- Ability to move and lift up to 50 pounds
- Good verbal and written communication skills
- Ability to work in a team environment
- Ability to pay attention to detail
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.