Snr Manager/Manager External Manufacturing, Clinical Supply Operations

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: January 14, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision --- transforming patients--- lives through science. In oncology, hematology, immunology and cardiovascular disease --- and one of the most diverse and promising pipelines in the industry --- each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.This position is responsible for cGMP Clinical Manufacturing Operations, scale-up, and technology transfer activities of small molecule drug products (DPs) for the development of new pharmaceutical products.Responsibilities:Manages the end-to-end production of clinical trial materials (business/technical interface through delivery of supplies) through an external network of suppliers with capabilities in oral solid dose and specialty products manufacturing.Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust clinical manufacturing processes for the drug products.Participates in technical due diligence to assess technical capabilities and compliance to quality agreements and systems.Performs a resource and cost analysis as required to define and justify outsourcing spend.Identifies and reports issues to appropriate levels of management and key stakeholders in a timely manner. Maintains all entries and updates to the External Manufacturing Book of Work in an accurate and timely manner.Develops detailed time and event schedules to define, manage and track all activities and milestones related to outsourced demand.Executes all required SAP transactions such as goods receipt and goods consumption. Utilizes SAP Engineering Change Management to create, review, modify and approve Bills of Material for long term and immediate demand. Converts planned orders (print and production) into purchases orders completing all required user fields and adding long text as required.Executes transaction on completed process orders. Compiles supporting documentation and delivers a body of evidence (i.e. batch records) that supports the release of finished supplies for clinical use. Liaises with Quality Assurance to secure release of finished supplies.Issues alert notices, conducts and documents investigations and develops and implements CAPAs.As required, tracks outsourcing spend and issues a quarterly analysis on YTD trends and compliance to budget.Requirements:B.S/M.S. Engineering or Science field with a minimum of 8 years of experience.Minimum 5 years of experience in OSD manufacturing in a pharmaceutical environment is required.Skills/Knowledge Required:Expertise across various solid oral dosage conventional and enabling manufacturing technologies.Expertise in leading scale-up and technology transfer, moving from laboratory to pilot plant and production scale.Demonstrated capability orchestrating development and execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.Knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.Knowledge of cGMP during pharmaceutical development and commercial manufacturing.Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.Strong project management and interpersonal skills. Ability to work in a fast paced, multidisciplinary environment and work independently. Strong verbal and written communication skills are essential.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Full time

Keywords: Bristol Myers Squibb, New Brunswick , Snr Manager/Manager External Manufacturing, Clinical Supply Operations, Executive , New Brunswick, New Jersey