Technical Transfer Lead

Company: RCM Technologies
Location: Cranbury
Posted on: March 20, 2023

Job Description:

Job Title: Technical Transfer LeadJob Function: Responsible for all aspects of transferring products / methods for a pharmaceutical contract manufacturerJob Type: 1 Year + contract / possible Right To HireLocation: Cranbury, NJ

Scope of Job: RCM is seeking a Technical Transfer Lead to support our client a leading drug Contract Development & Manufacturing Organization (CDMO). A successful candidate will be a highly motivated, energetic, and self-starter.

Working with the Business Management team and Technical Operations, ensure effective management of Technology Transfer (TT) projects from clients. This covers all aspects from feasibility analysis, through all defined TT activities, to effective commercialization start up, always following cGMP.
Key Responsibilities:
Technology Transfer

• Process definition supporting the Business Development Manager and using the relevant internal resources, define the scope of work required, including any adaptation required to fit our systems, for a new client project either in the bidding stage or upon award of project.
• Receive, collate, and disseminate technical information received from client to internal team and transfer such information into internal templates required for project delivery.
• Deliver coordination and management to the Technology Transfer, leading the internal communication of the project, convening the Technology Transfer Project Team, and leading the team to deliver activities and milestones within the TT plan.
• Matrix management manage the internal and client project team to best achieve project milestones. Define where resources or delays may occur and escalate to site management for resolution.
• With the allocated Business Development Manager act as the client key point of contact for all technical matters through the Technology Transfer process.
• Client Technical management maintains "point of contact with the client on technical issues and coordinates any internal responses with the relevant resources.
• Manage product and technology transfer process, as per regulatory requirements and internal Corporate and Product Development Services (PDS) policies/guidelines
• Facilitate Tech Transfer Core Team to ensure timely site readiness for technology transfer activities, including availability of materials, equipment, facilities, quality systems and environmental health and safety requirements.
• Act as main technical contact during communications between client and receiving site representatives and/or Corporate and PDS representatives on topics related to product and technology transfer activities.
• Oversee product and technology transfer activities progress and provide periodic update on project progress to Transfer Core Team members and TF management. Cost Management and control
  • Fiscal management scopes any fiscal requirements relevant to the project (primarily capital equipment and changes to scope) with internal resources and liaises with the Business Manager to ensure client agreement and payment.
  • Manage the TT project within the agreed budgetary framework
  • Minimize production costs by identifying and delivery of new purchasing solutions. Compliance
    • Comply with GMP requirements and company rules, policies, and procedures. EH&S:
      • Understand emergency procedures and comply with safe systems of work.
      • Always ensure compliance with environment, health and safety rules, signage, and instructions.
      • Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
      • Comply with new product introduction procedures to ensure correct evaluation of all compounds is completed before delivery to site Qualifications/Experience:
        • Relevant BSc in Engineering or Science
        • Over five (5) years of demonstrable experience in the pharmaceutical industry, preferably in the oral solid dosage operational environment.
        • Strong project management background within, for example, production engineering, validation or quality; with a solid understanding of manufactured dosage forms.
        • Client facing experience preferred.
        • Strong organizational and analytical abilities.
        • MS Office and Microsoft Project knowledge and skills.
        • Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
        • Strong project ownership ethic with a "can do attitude.
        • Ability to work within and deliver critical timelines.
        • Ability to motivate, communicate and lead cross functional teams to deliver project timelines.
        • Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
          About RCM: RCM Life Sciences & IT is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
          
          Equal Opportunity Statement RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
          DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Keywords: RCM Technologies, Trenton , Technical Transfer Lead, IT / Software / Systems , Cranbury, New Jersey