Technical Operations Program Director

Radius Pharm Waltham, MA
Overview

The Tech Ops Program Director is technically proficient and adept at participating and contributing in a cross functional team environment. This role is responsible for managing the scope, cost and time of supply chain and new formulation development projects through the planning, implementation, and closeout phases of the project life cycle. They will contribute to the production of high quality pipeline products by ensuring that all work is done in a manner compliant with cGMPs, SOPs, government regulations and corporate policies and procedures.

This position is involved with, planning/project management, logistics/information management and technical operations stewardship. Works closely with Supply Chain, Quality and/or Regulatory personnel as well as external research/contract organizations and will participate with a variety of internal and external teams.

Responsibilities

* Ensures all projects have timelines and that project teams have clear goals, objectives, and milestones consistent with Radius's objectives and financial goals.

* Interacts with Technical Operations, Quality, Regulatory, third party suppliers, corporate partners to create timelines that include:

* Analytical method development/validation timelines,

* Process improvements initiatives,

* Development studies for support of manufacturing or product use,

* Coordination of CMC contributions to NDA and other regulatory submissions.

* Launch Planning and management of milestones

* Coordinates new supply chain and quality project management activities between Technical Operations, R&D, Commercial, Finance, IT, etc. to ensure the timely product launches of domestic and global products to meet Radius objectives.

* Manages Technical Operations meeting, internal and with vendors, including as necessary authorship of agendas and meeting notes.

* Maintains key documents and plans including coordinating with Tech Ops contribution to regulatory submissions.

* Coordinates and manages risk assessment and develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices and standards that govern the pharmaceutical supply chain.

* Facilitates team level decision making and escalates key decisions to oversight committees.

* Identifies any potential or actual delays and prepares appropriate prevention and mitigation plans.

* Ensures effective collaboration and communication takes place in category and cross-functional organization. Communicates critical issues and resolution plans to Technical Operations management. Publishes meeting agendas, minutes and metrics.

* Manages Tech Ops initiatives to assure meeting timelines and maintains an understanding of contemporary project management techniques and laws and regulations applicable to the pharmaceutical/biotechnology industry.

Qualifications

* BS, graduate degree, or equivalent in life science, Business, Engineering.

* Minimum 10-15 years of experience Supply Chain or CMC project management, including experience in two or more of the following Biotech/Biological/Pharmaceutical Process Development, Product Characterization, Manufacturing, Quality Control, Analytical Development/Validation, or CMC-Regulatory.

* Project management experience in CMC-related projects. Solid understanding of CMC development milestones from Phase I to Commercialization and Effectively drive and maximize resources through the application of project management.

* Broad knowledge across the spectrum of technical operations including quality and the entire supply chain and demonstrated effective cross-functional leadership as evidenced by line/project management or multi-disciplinary program management.

* Proven experience using Project Management software (MS Project) to manage complex project timelines and resources, and excellent skills at Excel, Visio, and PowerPoint.

* Familiar with FDA, EU and ICH guidelines, as well as USP and EP.

Work Environment:

The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus

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