Associate Formulator

Role Description

Position Summary:

Formulate biological products, maintain/assess and extend antigen inventory, resolve technical issues, lead potency failure investigations, assist with completing aseptic procedures, and provide leadership for team members.

Position Responsibilities:

• Utilize the Autoform system to develop formulations for assembly.
• Ensure all assemblies are formulated within the respective Outline of Production and Dossiers
• Work to resolve issues that arise during the formulation of products to ensure compliance with Outlines of Production, Dossiers, and internal specifications.
• Assist with BOM maintenance.
• Ability to schedule and coordinate daily operations within BPM utilizing RFT methods.
• Interact with Supply Chain (SC) to ensure the production plan is set and followed.
• Interact with ABI and QA to ensure antigen inventory is maintained to meet production schedules, practicing first in, first out methods when possible.
• Act as a liaison between BPM, ABI, SC and QO to facilitate information flow.
• Assist with maintaining adequate inventory throughout all levels of BPM.
• Manage distressed inventory with SC.
• Manage Material Use Variance (MUV) with Production Controller.
• Assist in potency failure investigations.
• Track test results (i.e. control charts), to proactively identify issues or CIP opportunities.
• Assist VMRD, GMT and Manufacturing with conducting experiments, prototypes and/or production scale-up runs.
• Transfer of new products, PLS formulations and MD creation
• Identify improvements of existing products/processes
• Assist in the preparation of draft Standard Operating Procedures, (SOPs), and Process Worksheets to conform to APHIS, GMP, EH&S and ZQS's as required.
• Demonstrate SAP and LIMS knowledge.
• Ability to train others in Formulation.
• Maintain a high level of motivation and take initiative to form teams, compile information and complete projects within an established timeline and with minimal supervision.
• Assist with routine and emergency decisions using data, good judgment and experience.
• Demonstrate ability to conduct presentations, both written and verbal, to various groups using correct scientific terminology
• Annual Outline of Production review with Regulatory Affairs for vaccine formulation and assembly
• Responsible for temporary and permanent change controls associated with formulations/Autoforms and antigen extension.
• Review and approve Batch Record updates related with formulations.
• Assemble prototypes when applicable to determine vaccine formulations.
• Manage and lead antigen extension program. This includes associated formulations.
• Prototype formulation and assembly, change control, MRB management, and destruction management when applicable.
• Verify formulations.

EDUCATION AND EXPERIENCE

• BA/BS with 0-2 years of experience OR minimum of 6 years relevant work experience.

Technical Skills:

• Demonstrated computer skills, including MS Office, LIMS, Autoform, ETS, Excel.
• Demonstrated understanding of SOPs and cGMPs
• Knowledge of USDA, European, OSHA regulations and other regulations pertinent to area
• Strong communications skills both oral and written.
• Demonstrated ability to interact with and positively influence internal and external work groups.
• Expertise in metric system and math
• Ability to understand and execute mathematical functions.
• Working knowledge of scientific methods and demonstrated aseptic technique competence.
• Thorough understanding of antigens, their interactions with each other and the various stabilizers and adjuvants, and how variables affect the animal immune response.
• Plans and arranges own work, referring unusual matters to Team Leader
• Skilled in analyzing complex issues. Requires incumbent to possess innovation ability to define problems, develop alternative courses of action (skillful fact finding) and pick best possible solutions.
• Typing with Accuracy

PHYSICAL REQUIREMENTS

• Must be able to sit, walk, or stand for long periods of time.
• Must be able to wear a respirator.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Must be able to don proper PPE to include Tyvek gown.
• Must be comfortable in working in varying temperatures.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

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