This position is responsible for manufacturing product by vialing detection/capture antibodies, calibrators, or assembling antibody set products.
Responsible for preparing manufacturing records, dilution and blending of anitbody/calibrator materials, assemble 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 operate automated vialing, bottling, labeling, or lyphilizing equipmentMay handle BSL-2 reagents to produce calibrator products.
Provides input to improve routine manufacturing processes that provide for better quality and quantity of products.
Participates in 5S initiatives by maintaining and improving laboratory tidiness and efficiency.
Completes appropriate documentation to support process and production procedures including data entry and batch records and daily maintenance and documentation of all production equipment
Participates in general laboratory maintenance including maintaining laboratory cleanliness, supplies and equipment to include but not limited to: preparing, maintaining and reporting reagent inventories, maintain pipette calibration schedules, participating in year-end physical inventory, and defrosting freezers.
Specific duties may vary depending upon departmental requirements.
Associate's degree in Biology, Chemistry, Biotechnology, Engineering or related field field or equivalent work experience.
Prior manufacturing experience a plus.
Demonstrates an aptitude for learning and adhering to standard laboratory techniques and safety precautions.
Basic knowledge of scientific fundamentals.
Basic knowledge of pipetting.
Ability to follow laboratory safety instructions; ability to use protective equipment.
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.
Basic knowledge of cGMP and/or ISO certification highly preferred.
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 lifting up to 25 lbs.
Up to 80% of the day may be spent at a laboratory bench.
