Biochemist (Onsite)

Please note that this is a 9 months contract position. The position is onsite. College graduates are preferred.

Education and Experience:

B.S./B.A.

Life/Applied Sciences A minimum of 6 months of related work experience in a GMP environment.

Knowledge/Skills:

Basic algebraic, statistical, and mathematical skills General computer knowledge Good organizational skills Laboratory skills, such as protein purification, antibody conjugation, solution preparation ELISA experience, assay development skills , etc. Good verbal and written communication skills Good interpersonal skills Knowledge of QSRs and

ISO 9001

Knowledge of experimental design Basic Chemistry or Biochemistry

ESSENTIAL FUNCTIONS

Manufactures (i.e., Formulates bulks, and Quality Controls) products (i.e., Lateral flow devices, controls/calibrators, and microtiter systems) while adhering to regulatory requirements and business policies/procedures and schedules Supports departmental troubleshooting and process improvement teams Supports cross-functional projects and training Reviews completed Device History Records, performs financial review of work orders, and reports on variances to supervisor Maintains daily adherence to Production goals relating to MUV/LUV, labor utilization, work order closure, and schedule adherence

INTERACTIONS

Inventory Control obtains/returns materials, resolves material variances related to work order usage Reconciles work orders, enters/checks labor hours, checks material availability, BOMs, general manufacturing queries, and closes work orders; prepares work order variance reports Process Engineering technical troubleshooting, product transfers Production coordinates optimization/matrix assembly Planning reports on schedule adherence Quality/Documentation ECOs, NCMRs, deviations, validations, QTPs

WORK ENVIRONMENT

The work environment characteristics are representative of a laboratory environment and include: Handling of viral and bacterial hazards Handling potentially hazardous chemicals Handling infectious or potentially infectious bodily fluids, tissues, and samples Flexible work hours to meet project deadlines

PHYSICAL DEMANDS

Ability to lift up to 20 lbs. on a regular basis Up to 75% of time at lab bench or desk; walking, standing, and sitting for long periods of time are routine Specific vision abilities required include close and distance vision and the ability to adjust focus Must have the ability to operate lab equipment Use of Personal Protective Equipment (PPE) as posted

SUMMARY OF POSITION

In accordance with forecasted requirements, participates in the manufacture of products within QSR and ISO regulations .

This position:

Reviews and reconciles documents and work orders Supports assigned projects with supervision Participates in product transfers Supports departmental troubleshooting and process improvement teams Displays an improving working knowledge of business processes as they relate to manufacturing Candidates must provide their phone number. Job reference number is A5252.