Biochemist 1 – Chromatography Workcenter – Weekend Coverage

Siemens Healthineers

13d

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The primary role of this individual is for chromatography manufacturing. The scope of this role includes manufacture and audit of production batches for the Antibody Purification work center. The scope of this role may include manufacture of production batches for the Concentrates work center. The scope of this role includes auditing of chromatography batch records. This role will provide weekend coverage, Tuesday – Saturday or Sunday - Thursday 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, and compliance. This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Biochemist 1, Chromatography Workcenter, Weekend Coverage, will be responsible for: Manufacturing of Purified Antibodies, Purified Conjugates, and Concentrates, via liquid chromatography Auditing and GMP/GDP verification of batch records and product release responsibilities Details of job tasks include: 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 May be required to stay late and/or work off-shift hours on any given day.

Requirements

Bachelor’s Degree required. (Biology, Chemistry, Engineering, or other applicable Science Degree) or equivalent work experience
3-5 years manufacturing work experience
Chromatography 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.

Nice To Haves

Experience with AKTAs
A background in manufacturing processes
Familiarity with GMP/GDP guidelines

Responsibilities

Manufacturing of Purified Antibodies, Purified Conjugates, and Concentrates, via liquid chromatography
Auditing and GMP/GDP verification of batch records and product release responsibilities
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
May be required to stay late and/or work off-shift hours on any given day.