6208 - Sr. Associate Material Coordinator / Program Manager

Verista, Inc.•Indianapolis, IN

5h•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Requirements

Excellent oral and written communication skills with the ability to interact well in a team environment
Ability to develop/manage relationships with contract partners
Ability to collaborate with partners around the world
Initiative and ability to handle multiple projects in an independent fashion
Excellent organization and self-management skills
High initiative, flexible and positive attitude
Ability to respond to changing priorities and short lead times
Experience with SAP
Experience in managing inventory/supplies or complex supply chains
Knowledge of clinical trial manufacturing operations
Ability to use and apply multiple computer applications
Ability to proactively identify problems and work toward a solution
Minimum 1 year in a GMP environment
Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations
Onsite job requirement in Indianapolis, IN.

Responsibilities

Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
Maintain SAP data related to orders in support of the organization, this includes:
Establish new materials and purchasing information aligned with sourcing decisions
Create new vendor and customer numbers as needed
Establish Source List for triangulated sales products as needed
Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
Build strong relationships with development organizations through routine touch points
Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
Coordinate activities and communicate timing on incoming and outgoing shipment schedules
Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
Conducts periodic inventory reconciliations
Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
Participates in departmental site self-assessments and relevant audits