Associate Formulator

Zoetis•Charles City, IA

About The Position

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.

Requirements

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

Responsibilities

Formulate biological products
Maintain/assess and extend antigen inventory
Resolve technical issues
Lead potency failure investigations
Assist with completing aseptic procedures
Provide leadership for team members
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