Reagent Chemistry Associate – Mid Level

Company overview: ALPCO provides immunoassay and flow cytometry-based products to the life science research and medical diagnostic industries. Customer segments include routine clinical labs, biotech/pharmaceutical R&D labs, CRO’s and academic research institutions.  The company employs a hybrid distribution/manufacturing business model.  ALPCO’s products are derived from organic R&D and cGMP production operations, as well as externally sourced products in the form of either OEM “ALPCO branded” products, or products sold via pure distribution under the original manufacturer’s label.

Position:  Reagent Chemistry Associate – Mid Level

Reports to:  Reagent Chemistry Manager

Overview of position: The Reagent Chemistry Associate works under general supervision and is expected to follow established procedures in the manufacture of ELISA kits and components; can perform standard manufacturing procedures and has knowledge of commonly used laboratory concepts and practices; relies on instructions and established guidelines or protocols to perform job functions; self starter who can work under minimal supervision.  

Responsibilities: 

• Follows and assists in configuring a manufacturing schedule.
• Interdepartmental functionality as it relates to manufacturing by having interactions with Quality Control, Quality Assurance, and R&D to provide information and support for intermediate and finished products.  
• Uses cGMP/GDP while performing manufacturing processes such as buffer formulations (includes filling, capping, and labeling), preparation of standards and controls, titrations, plate coating, lyophilization, and conjugations.
• Ability to calculate adjustments based on analyzed data. (i.e., serials dilutions and titrations)
• Advanced Experience with, but is not limited to Deviations, CAPA(s), and NCMR(s), and change orders.
• Performs bulk inventory control by ordering, tracking, sequestration, and waste.
• Participates directly in and documents the operation, maintenance, and calibration of manufacturing methods and equipment.
• Coordinates and assists with Laboratory up-keep, as necessary.
• Coordinates and assists in inventory reconciliation by maintaining accurate records on inventory labels and assisting in cycle counts.
• Follows safety procedures while working in and around the lab space.
• Proficient ability to interpret and actively troubleshoot data.
• Train other team members on various manufacturing tasks as needed including but not limited to the following manufacturing responsibilities:
  • Filling, Capping and simple Formulations.
  • Advanced Formulations, Conjugations, Biotinylating and Lyophilization.
  • Plate Coating and Operating OBPW Instrument.
  • Titrations, Value Assignments and Qualification/ In-process testing.

Skills & Qualifications:

• Bachelor’s degree in the Sciences (preferably in Chemistry or Biology) or equivalent combination of education and experience required.
• Experience in a GMP environment.
• Must possess advanced written and verbal communication skills, including but not limited to revision of Manufacturing related Quality documents.
• Proficient with MS Office Programs, particularly Excel and Word.
• Detail orientation and multitasking skills are a must.
• Requires physical ability to lift or carry objects weighing 40 lbs. or less, occasionally pushing, pulling objects weighing 100 lbs. or less.