Project Manager, Healthcare Management

Overview

Job Title: Technology Transfer Project Manger

Location: Indianapolis, IN

Client: Brooksource Pharmaceutical Manufacturing Client

Description:

The Commercialization Project Manager (PM) role provides project management oversight to achieve the reliable and compliant manufacture of new device and packaged products to support CMC agendas and timelines. This role serves as the conduit between development and the site for projects spanning from clinical trials to initial commercial launches including the associated technology transfer activities.

The Commercialization PM is responsible for leading technical teams to commercialize devices and packaged products. This role is expected to demonstrate Leadership, Business Acumen, Project Management skills, and Commercialization / Technology Transfer Process Knowledge. Additionally, the role will interface outside the manufacturing site with Network Project Managers, CMC Project Managers, and DDCS Project Managers.

• Understand the scientific principles required for Device Assembly and Packaging operations
• Manage the DAP commercialization portfolio for assigned projects – including driving prioritization for the site with an understanding of resourcing and constraints
• Lead cross functional teams through the Tech Transfer Process for commercialization of new products in DAP
• Establish timelines and drive technical teams to meet customer requirements and supports CMC and Regulatory timelines
• Responsible for Tech Transfer Plans / Reports and delivery of Commercialization Reviews (Gates) to site leadership
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan, commercialization, and quality objectives
• Support identification and development of new manufacturing technologies and processes in DAP to support commercialization
• Optimize commercialization process in DAP by identifying opportunities for efficiency and consistency for new product commercialization efforts
• Bachelor’s degree or equivalent in a scientific discipline
• Technical / Scientific knowledge
• Good written and oral communications
• Clear understanding of cGMPs
• Good teamwork and interpersonal skills
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

• Decision making
• Multi-tasking
• Ability to influence groups and communication skills
• Problem solving
• Good teamwork and interpersonal skills
• Good written and oral communications
• Knowledge of the CMC aspects of drug development and manufacturing

Bachelor’s degree or equivalent in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Pharmacy, or Engineering are minimum requirements.