Drug Product Tech Transfer Lead ; Biologics

Position: Drug Product Tech Transfer Lead Role (Biologics)
Job Description:

The Technical Launch Integrator (TLI), posted as Drug Product Tech Transfer Lead, has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations & technologies. The TLI is also responsible for the execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace, as well as site-to-site transfers keeping the Best Process/Product at Launch (BPAL) mindset.

Areas of key functions include DP technical support and oversight for supply chain, planning and execution of DP manufacturing site level support of new product launch.
Objectives of the Position  Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain while using new innovations & technologies keeping the Best Process/Product at Launch (BPAL) mindset. Contribution, review, and approval of drug product technical and regulatory documents, routine technical support, integration of supply chain technical expertise into project execution, and Quality by Design (QbD) technical implementation at the manufacturing site level.

Single point of contact for supply plant readiness and execution and launch support between the Development and Commercial supply chain organizations. Identify and implement opportunities for active decrease of Cost of Goods (COGs) and partner with Development and supply chain groups to implement strategies to improve process robustness, fit for plant, and commercialization of new products into the supply chain.

Develop the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the relevant cross-functional teams; ensure alignment and endorsement of this strategy within the manufacturing site and TLI function. Coordinate and implement product introduction at the site from transfer through launch covering raw materials, formula, process, packaging, and device integration into the finished product.

Optimize the New Product Introduction (NPI) process, make use of technology platforms, accelerate development timelines, and streamline the technical transfer process.
What you will need to succeed  Ability to foster team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the various matrix teams, and influence with or without direct authority. Motivated, self-starter able to work independently with proven problem-solving skills.

Qualifications:

Minimum of a Bachelor's or equivalent degree (required). M.S. or PhD
Minimum 6 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions, or equivalent (required).

Experience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (required).
Knowledge of manufacturing site systems and procedures, including an understanding of GMP requirements (required).
Knowledge of DP late-stage development (preferred).

Experience with document management systems such as RIMdocs, Tru Vault, SAP, MS Office applications, Comet, and/or Planisware (preferred).
FPX, PMP, or equivalent Project Management certification (preferred).
Proficient in English (required) language
Up to 20% domestic and international travel, depending on project needs (required)
Preferred

Skills:

Agile Decision Making
Business Savvy
Coaching
Corrective and Preventive Action (CAPA)
Crisis Management
Critical Thinking
Disruptive Innovations
Emerging Technologies
Industrial Hygiene
Lean Supply Chain Management
Organizing
Process Control
Process Engineering
Product Costing
Program Management
Project Schedule
Science
Technology
Engineering
Math (STEM) Application
Technical Research