Associate Formulator
Zoetis
2 hours ago
On-site
Charles City, IA
Clinical Research and Development
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 assemblies are formulated within the applicable Outline of Production and Dossiers.
- Resolve formulation issues to ensure compliance with Outlines of Production, Dossiers, and internal specifications.
- Assist with BOM maintenance.
- Schedule and coordinate daily operations within BPM using RFT methods.
- Coordinate with Supply Chain (SC) to ensure the production plan is set and followed.
- Coordinate with ABI and QA to maintain antigen inventory for production schedules (use first-in, first-out when possible).
- Serve as a liaison between BPM, ABI, SC, and QO to facilitate information flow.
- Maintain adequate inventory across BPM levels; manage distressed inventory with SC.
- Manage Material Use Variance (MUV) with the Production Controller.
- Assist with potency failure investigations.
- Track test results (e.g., control charts) to proactively identify issues and/or CIP opportunities.
- Support VMRD, GMT, and Manufacturing with experiments, prototypes, and/or production scale-up runs.
- Transfer new products, PLS formulations, and support MD creation.
- Identify improvements to existing products/processes.
- Assist in drafting SOPs and Process Worksheets to conform to APHIS, GMP, EH&S, and ZQS requirements.
- Demonstrate knowledge of SAP and LIMS.
- Train others in formulation.
- Motivate and take initiative to form teams, compile information, and complete projects on timeline with minimal supervision.
- Make routine and emergency decisions using data, judgment, and experience.
- Deliver written and verbal presentations using correct scientific terminology.
- Participate in annual Outline of Production review with Regulatory Affairs for vaccine formulation and assembly.
- Manage temporary/permanent change controls for formulations/Autoforms and antigen extension.
- Review and approve Batch Record updates related to formulations.
- Assemble prototypes when applicable to determine vaccine formulations.
- Manage and lead antigen extension program (including associated formulations).
- Support prototype formulation/assembly, change control, MRB management, and destruction management as applicable.
- Verify formulations.
Education and Experience:
- BA/BS with 0–2 years of experience OR minimum 6 years relevant work experience.
Technical Skills / Qualifications:
- Computer skills: MS Office, LIMS, Autoform, ETS, Excel.
- Understanding of SOPs and cGMPs.
- Knowledge of USDA, European, and OSHA regulations (and other relevant regulations).
- Strong oral and written communication; ability to influence internal/external groups.
- Expertise in metric system and math; ability to execute mathematical functions.
- Working knowledge of scientific methods and demonstrated aseptic technique competence.
- Thorough understanding of antigens, their interactions, and effects of stabilizers/adjuvants on animal immune response.
- Ability to plan and arrange own work; refer unusual matters to Team Leader.
- Skilled in analyzing complex issues; innovative problem-solving and selecting best solutions.
- Typing with accuracy.
Physical Requirements:
- Sit, walk, or stand for long periods.
- Wear a respirator; don proper PPE (including Tyvek gown).
- Reach above shoulder level; bend/stoop, kneel, push/pull, and handle/grip frequently.
- Work scheduled 40 hours; overtime as needed.
- Comfortable in varying temperatures.
- Frequent lifting/carrying of 5–25 lbs; frequent reaching, bending, stooping, twisting; repetitive wrist/hand/finger motion.
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 assemblies are formulated within the applicable Outline of Production and Dossiers.
- Resolve formulation issues to ensure compliance with Outlines of Production, Dossiers, and internal specifications.
- Assist with BOM maintenance.
- Schedule and coordinate daily operations within BPM using RFT methods.
- Coordinate with Supply Chain (SC) to ensure the production plan is set and followed.
- Coordinate with ABI and QA to maintain antigen inventory for production schedules (use first-in, first-out when possible).
- Serve as a liaison between BPM, ABI, SC, and QO to facilitate information flow.
- Maintain adequate inventory across BPM levels; manage distressed inventory with SC.
- Manage Material Use Variance (MUV) with the Production Controller.
- Assist with potency failure investigations.
- Track test results (e.g., control charts) to proactively identify issues and/or CIP opportunities.
- Support VMRD, GMT, and Manufacturing with experiments, prototypes, and/or production scale-up runs.
- Transfer new products, PLS formulations, and support MD creation.
- Identify improvements to existing products/processes.
- Assist in drafting SOPs and Process Worksheets to conform to APHIS, GMP, EH&S, and ZQS requirements.
- Demonstrate knowledge of SAP and LIMS.
- Train others in formulation.
- Motivate and take initiative to form teams, compile information, and complete projects on timeline with minimal supervision.
- Make routine and emergency decisions using data, judgment, and experience.
- Deliver written and verbal presentations using correct scientific terminology.
- Participate in annual Outline of Production review with Regulatory Affairs for vaccine formulation and assembly.
- Manage temporary/permanent change controls for formulations/Autoforms and antigen extension.
- Review and approve Batch Record updates related to formulations.
- Assemble prototypes when applicable to determine vaccine formulations.
- Manage and lead antigen extension program (including associated formulations).
- Support prototype formulation/assembly, change control, MRB management, and destruction management as applicable.
- Verify formulations.
Education and Experience:
- BA/BS with 0–2 years of experience OR minimum 6 years relevant work experience.
Technical Skills / Qualifications:
- Computer skills: MS Office, LIMS, Autoform, ETS, Excel.
- Understanding of SOPs and cGMPs.
- Knowledge of USDA, European, and OSHA regulations (and other relevant regulations).
- Strong oral and written communication; ability to influence internal/external groups.
- Expertise in metric system and math; ability to execute mathematical functions.
- Working knowledge of scientific methods and demonstrated aseptic technique competence.
- Thorough understanding of antigens, their interactions, and effects of stabilizers/adjuvants on animal immune response.
- Ability to plan and arrange own work; refer unusual matters to Team Leader.
- Skilled in analyzing complex issues; innovative problem-solving and selecting best solutions.
- Typing with accuracy.
Physical Requirements:
- Sit, walk, or stand for long periods.
- Wear a respirator; don proper PPE (including Tyvek gown).
- Reach above shoulder level; bend/stoop, kneel, push/pull, and handle/grip frequently.
- Work scheduled 40 hours; overtime as needed.
- Comfortable in varying temperatures.
- Frequent lifting/carrying of 5–25 lbs; frequent reaching, bending, stooping, twisting; repetitive wrist/hand/finger motion.