Biochemist

6 days ago

east walpole, United States Comrise Full time

Overview

Biochemist 1, for weekend coverage.

The working days are Wed – Sunday with training on Mon – Friday.


The primary role of this individual is for chromatography manufacturing. The scope of this role includes manufacture of production batches for the Concentrates work center. The scope of this role may include manufacture of production batches for the Purification work center. This role will provide weekend coverage, Wednesday – Sunday with training occurring on Monday – Friday. Candidate must demonstrate the ability to understand formulation processes, work with processes and equipment, detailed written documentation of work, ability to work well with others


Responsibilities

You will be responsible for:

• Manufacturing of Concentrates, Purified Antibodies, and Purified Conjugates via liquid chromatography

• Auditing and GMP/GDP verification of batch records and product release responsibilities.

• This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.


Your role:

• Following established manufacturing protocols to conjugate and/or isolate proteins for use in immunological assays.

• Buffer and chromatography column preparation

• Maintaining a legible and accurate batch record according to proper GMP

• Making decisions and executing critical steps in the manufacturing process

• Maintaining an FDA/DEA compliant laboratory

• Providing Quality Notification Support

• Executing temporary manufacturing deviations and pilot products

• Completion of all necessary training activities


Qualifications

Your expertise:

Preferred Knowledge/Skills, Education, and Experience

• Experience with AKTAs

• A background in manufacturing processes

• Familiarity with GMP/GDP guidelines


The requirements:

Required Knowledge/Skills, Education, and Experience

• Bachelor’s Degree required. (Biology, Chemistry, Engineering, or other applicable Science Degree)

• 3-5 years chromatography work experience.

• Proficiency with basic lab equipment (pipettes, balances, centrifuges)

• Proficiency in Microsoft Office Programs

• Strong communication and organizational skills

• Strong mathematical and critical thinking skills

• Must have legible handwriting.

• Must be able to safely lift 50lbs*Must pass a Drug Enforcement Agency (DEA) background check.

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