Janssen - Technical Launch Integrator

For the Italian production plant of Janssen (Borgo San Michele - Latina) we are looking for a **Technical Launch Integrator **(Senior Scientist or Principal Scientist/Engineer) to be hired with a permanent contract.

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 marketplace. A main objective of the role is strong collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed, successful transferred, and launched commercially.

As a TLI, you will be a member of the Janssen Supply Chain (JSC) Value Chain Team (VCT) and manufacturing operations teams, working hand-in-hand with R&D to successfully develop products and transfer to the commercial launch site (internal or external). The focus of this position will be primarily on small molecule (SM) Drug Product (DP), including tablets and oral suspensions/solutions. In this role, you will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The TLI work in close collaboration with other roles to shape new product processes, and must have strong communication skills to influence other functions/levels outside of own group. In this role you will effectively lead global and cross organizational teams to generally attain desired results for all parties. Strong knowledge of SM DP manufacturing processes is a must. Hands-on experience in both formulation development and manufacturing operations is highly desirable.

Do you have strong leadership and project management skills, and do you have a passion for manufacturing process excellence and innovation? If so, then you may be the person we are looking for

**Key Responsibilities**:

- Technical and manufacturing integration of new products from R&D into the supply chain (focus on small molecule drug product)
- Leading the manufacturing site team and being the manufacturing site representative on the R&D team and the Value Chain Team. Ensuring fit for plant, site readiness, launch readiness, and post launch stabilization
- Serve as the JSC technical point of contact and expert providing required manufacturing technical support, documented technical input, review, and approval leading to best-process-at-launch initiatives
- Contribute to, review, and approve regulatory documents for global markets
- Build value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing EHS, QA, compliance, and financial requirements

**Qualifications**:
**Education**:
Advanced degree (MS) required, Doctoral degree a plus, in a Scientific or Engineering field such as Chemistry, Pharmacy, Pharmaceutics, or Chemical Engineering

**Experience and Skills**:
**Required**:

- At least 8 years of relevant work experience in the areas of formulation development and manufacturing of solid dose DP, with hands-on experience in formulation development and commercial manufacturing preferred
- Broad proven technical background in solid dose DP manufacturing, process & product development, quality, cGMP and regulatory knowledge related to Small Molecules
- Strong communication skills and effectively communicates across all levels (shop floor to leadership), with ability to lead and influence without direct line authority
- High level of maturity to lead complex projects and teams, programs, or initiatives, both internally and externally
- Strong risk assessment / risk management skills, able to balance considerations toward business, scientific, quality, EHS, and compliance needs
- Knowledge of plant functionality, plant capacity, and COG calculations
- Eye for business: negotiation and sourcing strategies and financial impact
- Decision making and problem-solving: able to seek solutions to complicated problems independently or through others and develops recommendations or design solutions
- Investigation handling and statistical assessments supporting Continued Process Verification, ensuring robust processes

**Preferred**:

- International experience and interest in collaborating with various cultures / nationalities / perspectives
- Knowledge of contract manufacturing activities and crafting working relationships with global external partners
- Influences others with shared or different interests often beyond scope and level, networking, convincing for priority setting, both internally and externally to the company
- Besides excellent solid dose DP manufacturing know-how, knowledge and willingness to learn advanced technologies like continuous manufacturing

**Other**:

- Proficient in written and spoken English
- Works in an international environment across different time zones
- Project management Certifications preferred
- International and domestic