Job Description:

The Technical Launch Integrator (TLI) has overall accountability for ensuring fit-for-plant and commercial readiness during technical development and execution of the transfers of pharmaceutical manufacturing processes and products into the supply chain and the global marketplace, including site-to-site transfers.

Areas of key responsibility include parenteral DP technical support and oversight for the supply chain, planning and execution of DP manufacturing site activities from transfer through new product launch, stable initial commercial production, and managing launch & grow phase of a product.

The TLI is a member of MSAT manufacturing site operational teams, Value Chain teams, R&D sub-teams (including CMC ad-hoc), and leads the new production introduction team at the internal or external manufacturing site.

Responsabilities:

• In collaboration with TDS and Value Chain, prepares and executes the product development roadmap as strategic framework to guide process development, manufacturing site selection, financial decisions, and supply chain decisions.

• Partners with the Scientific Integrator (SI) to provide all manufacturing site-related needs to the R&D sub-team as the single point of contact for the site.

• Serves as the leader of the product specific site and or global team, as the J&J IMSC technical representative on the CMC

• Sub-team, R&D SI Sub-team, and as site representative on the Value Chain Team (VCT).

• Develops the manufacturing site execution plan per product and ensures alignment with stakeholders.

• Coordinates and executes product introduction at the site from sourcing to technology transfer from R&D through launch, covering raw materials and process integration. Supports the VCL (Value Chain Lead) for site related launch activities.

• Delivers clinical and commercial supply from the manufacturing site ensuring manufacturing performance, cost, and robustness requirements are met.

• Partners with TDS to provide early process design inputs to improve ‘fit for plant’ and commercialization of new products into the supply chain. Represents J&J IMSC in all Tech Transfer activities (i.e. BPAL, DfM, PF2P, COGS, INR) during the development process and ensures alignment in MSAT.

• Responsible for delivering a manufacturing process capable of meeting the GP profitability targets together with R&D.

• Carry out COGS Sensitivity Assessments and provide early process design inputs.

• Oversees Tech Transfer from R&D facilities (internal and external) to plants in the J&J IMSC internal and PES external network. The scope includes early development, full development, launch phase, and initial life cycle management.

• Contributes to, reviews, and approves technical and regulatory documents; provides routine technical support during execution; integrates J&J IMSC technical expertise into project execution.

Qualifications:

Degree

• BS (required), MS or PhD. (preferred) in Scientific or engineering discipline or equivalent in a technical field (Chemistry, Pharmaceutics, Chemical Engineering), with at least 5-8 years’ experience in the pharmaceutical development or manufacturing area.

Skills

• Chemical and drug product/substance manufacturing (as appropriate), process & product development; quality, GMP and regulatory knowledge; broad technical background in small or large molecule pharma as appropriate

• Knowledge of plant functionality, plant capacity, and Cost-Of-Goods calculation

• Business acumen: sourcing strategies & understanding their financial impact

• Ability to assess the correct balance between business targets and scientific, quality, EHS and compliance decisions

• Risk management

• Knowledge of contract manufacturing activities

• Ability to create and maintain culturally sensitive working relationships with internal and external partners

• Leadership and negotiation

• Demonstrates effective communication skills across all levels of organization

• Decision making and problem solving; able to solve complex and uncommon problems independently and/ or in liaison with others

• Influences others with shared or different interests often beyond scope and level; influencing the process of priority setting both internally and externally

• High level of maturity to lead moderate to large, complex projects and teams, programs, or initiatives, both internally and externally

Other:

• Works in an international environment across different time zones

• Travel: up to 20% - project dependent

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