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.