- Title: Technical Launch Integrator
- Code: RCi-0709
- Location: Rockville Maryland (MD) 20847
- Posted Date: 07/09/2020
- Duration: 9-12 Months
- Name:Anish Patel
- Email: Anish.Patel@rangam.com
- Phone: 908-704-8843 ✖ 208
Bring Your Own Device (BYOD)/Laptop
Contract Scientist needed in the Technical Operations Large Molecule Global Team for a position of Drug Product Technical Owner/Technical Launch Integrator (New Product Introduction). This individual will be part of New Product Introductions.
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place.
The TLI is a member of the manufacturing site operational teams, CMC DPD Sub team, and New Product Team and leads the new production introduction team at the DP or DS site.
- Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large and small molecule).
- Leading the DP manufacturing site team and manufacturing site representative on the DPD Sub team and the New Product Team.
- Single point of contact for Supply Chain plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.
- technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants.
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of technical expertise (e.g., platforms, engineering, SME’s) into project execution and QbD technical implementation at the manufacturing site level.
- Strong project management skills with experience in supporting the execution of large-scale projects. You should have a sound sense of urgency, process-oriented skills, attention to detail, outstanding teaming and collaboration skills
- Good communication skills including technical writing proficiency
- Experience with Small Molecule and/or Large Molecule pharmaceuticals; research and development; Technical Operations; API/ Drug Product Manufacturing; Quality; Regulatory; Drug Development.
- Ability to lead, encourage and coach project teams and individuals
- The job requirements are specific and fast paced – candidates should have a technical & manufacturing background with a detailed aseptic processing understanding, good project management and interpersonal skills
- She or he should also be able work with Health Authorities and technical representatives from Partners and Contract Manufacturers, and to provide answers to HA questions on regulatory documents, ensure technical PAI inspection readiness, etc.
- Knowledge in process validation, equipment qualification and aseptic process equipment requirements
- Lead multi-functional and third-party teams for complex investigations, Tech Transfer and process improvement projects.
- General knowledge of the pharmaceutical industry
- Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP.
- Knowledge of manufacturing site systems and procedures