Formulation Technician II

POSITION SUMMARY

This position is responsible for reconstituting calibrator materials, vialing of detection/capture antibodies, calibrators, and/or assembling of antibody set products.

DUTIES AND QUALIFICATIONS

• Responsible for properly handling temperature and light sensitive reagents, preparing manufacturing records, reconstituting calibrators, diluting and blending of anitbody/calibrator materials, aliquoting materials, assembling vial sets, and printing of labels as instructed by Standard Operating Procedures (SOP) in order to produce final goods products for MSD customers.
• Performs peer review of product labels prior to vialing as the first quality check in the production process.
• May lead up operation of automated vialing, bottling, labeling, or lyophilizing equipment.




• Perform basic troubleshooting of equipment




• Manufactures customer contract materials with specialized procedure and handling requirements.
• Follows established protocol to executes reworking of non-conforming products.
• May participate in inventory control by issuing or completing materials to work orders
• Assists the Lead Formulation Technician with training of other manufacturing personnel.
• May handle BSL-2 reagents to produce calibrator products.
• Provides input and execute tasks to improve routine manufacturing processes that provide for better quality and quantity of products.

• Completes appropriate documentation to support process and production procedures including data entry and batch records and daily maintenance and documentation of production equipment.

• Performs general laboratory upkeep to include but not limited to maintaining laboratory cleanliness, supplies and equipment, preparing, maintaining and reporting reagent inventories, maintaining pipette calibration schedules, participating in year-end physical inventory, and defrosting freezers.
• Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering or related field or an equivalent of associates degree and two years of applicable work experience.

KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrates an aptitude for learning and adhering to standard laboratory techniques and safety precautions.
• Thorough knowledge of scientific fundamentals with an analytical background.
• Thorough knowledge of pipetting required.
• Excellent oral, written communication and interpersonal skills.




• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data




• Proficiency in MS Office Suite.
• Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities.
• Knowledge of cGMP and/or ISO certification highly preferred.
• Ability to learn additional software applications/tools, as required.
• Ability to utilize equipment necessary to perform the essential duties of the job.
• Ability to move/lift up to 25 pounds.

• Utilize equipment necessary to perform the job, and moving/lifting up to 25 lbs.

PHYSICAL DEMANDS

• Up to 80% of the day may be spent at a laboratory bench.

WORK ENVIRONMENT

Standard industrial laboratory environment