Brammer Bio, LLC is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
Planning Associate with relevant experience in a cGMP regulated industry and working knowledge of SAP, ERP systems. Basic knowledge of best practices in a defined area of expertise. Working knowledge of manufacturing process operations, scheduling, and inventory control practices. Basic understanding of relevant industry issues. Excellent communication, collaboration, and written/oral communication skills. Team oriented, able to manage complexity and multiple priorities. Possess analytical skills to troubleshoot conflicts; general understanding of inventory control and associated applications. General knowledge of other operational areas, such as QC/QA, Warehousing, Manufacturing Sciences, and Procurement.
This role is responsible for Production Planning, assuring all Contract Manufacturing Operation (CMO) plant production and associated site planning support activities are executed in compliance using standard operating procedures in a current Good Manufacturing Practices (cGMP) environment, where applicable.
Essential Job Functions:
- Daily planning operations supporting the manufacturing facility
- Planning for and ensuring availability of raw materials, components, and resources per the site s detailed manufacturing schedule.
- Facilitate and coordinate activities with all departments to ensure the availability of raw materials for plant operations supporting development through commercial production.
- Review cGMP production records and perform associated inventory transactions in the ERP system.
- Develop, maintain and evaluate required Bill of Materials, Recipes, and Production Versions in the site s SAP ERP environment in accordance with the site Master Production Schedule (MPS). Ensuring all additional required Production Planning master data is accurate.
- Provide training and perform testing for SAP Production Planning module as needed.
- Develop and maintain associated procedures and work instructions to ensure accurate use of the ERP system.
- Work with cross-functional teams to develop accurate list of materials required for innovative programs through the knowledge transfer process with the client.
Under the direction of the Materials Planning Manager, participate in all manufacturing planning of raw materials.
- Monitor the manufacturing schedule as it relates to raw material inventory and consumption.
- Collaborate daily with Manufacturing, Supply Chain, Quality Control, and Quality to resolve raw material issues, scheduling conflicts, inventory levels, and delivery requirements.
- Issue the monthly expired material report and hold monthly meetings (if needed) to ensure raw materials are released to support manufacturing planned demand.
- BOM/recipe creation and creation/reconciliation of production batches as needed in SAP.
- Monitor and track raw material usage and inventory levels, excel and obsolete analysis/forecasting, end-of-month report review; enter and complete raw material/API/finished product cycle counts and participate in tech transfers and bill of material development/maintenance.
- Review production schedules daily to coordinate manufacturing needs with Supply Chain and manufacturing to determine production activities that require entry/updating in SAP
- Responsible for raw materials planning and inventory control activities, including forecasted demand maintenance, and safety stock/ROP levels.
- Responsible for tactical day-to-day raw material planning and inventory control activities, including creation and allocation of raw material to batches for raw material movement and dispensing. Monitor special projects where out-of-FIFO materials are used to ensure correct allocation.
- Ensure timely and accurate reconciliation of batches in SAP. Interact with manufacturing to complete month-end closing activities.
- Revise and maintain SOPs, SLRs, BOMs, recipes, and production versions in SAP.
- Support tech transfers and the development/maintenance of manufacturing bills of materials, as needed, and ensure that the raw materials are procured and on hand to support the manufacturing schedule.
- Analyze data and create the Expired and Obsolete report at pre-determined frequency.
- Global Change Control and Exceptions Management. Initiations, review, closure of deviations within the ETQ System.
Thermo Fisher offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, and an incentive bonus plan.
Thermo Fisher is an Equal Opportunity Employer and participates in eVerify.
- Pharmaceutical/Biopharmaceutical or related industry background
- Basic understanding of Project Controls/Planning
- Microsoft Office Applications of Excel, Project, PowerPoint and Word
- SAP, or other ERP/MRP systems
- cGMP Manufacturing
- Strong analytical skills a must
- Detail oriented
- Ability to multitask in a fast-paced environment
Education and Qualifications:
- Bachelor s Degree preferred
- 2-5 years of Planning experience in a manufacturing setting
- Excellent verbal and written communication skills
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.