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