Drug Product Technical Launch Integrator

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission. #Li-Hybrid

We are searching for the best talent for a Drug Product Technical Launch Integrator (TLI)! This hybrid position will be located in Latina IT; alternative location may be considered in Beerse BE.

Would you like to join our world-class team

The 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 collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed and successful transferred considering Best Process at Launch (BPAL) principles. Areas of key responsibility include Drug Product Process technical support and oversight for the supply chain.

As a TLI you will be a member of Supply Chain Value Chain Team (VCT) Site operational teams and lead the new product introduction team at the sites. You will also be a full member of several R&D teams CMC Sub teams and R&D SI (Scientific Integrator) sub teams working hand in hand with R&D to optimally develop and transfer to the commercial launch site.

The focus of this TLI position is on drug product within the Synthetic Platform

Key Responsibilities:

• Facilitate commercial site technical support during execution of transfer activities.

• Ensure incorporation of technical expertise to include Best-Product-At-Launch and Quality-by-Design principles by providing input from early development through late development encouraging alignment between R&D and Supply Chain.

• Draft 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 innovation EHS QA compliance and financial requirements.

• Develop the execution plan per product in line with the overall strategy as outlined by the R&D CMC and Value Chain teams. The TLI will ensure alignment and endorsement of this strategy within the sites and TLI function for Supply Chain MSAT.

• Providing required manufacturing site based technical support technical documentation input review and approval and serving as Supply Chain technical product authority.

• Coordinate product introduction at the site from transfer through launch covering raw materials process EHS engineering packaging sterilization (if required) and other items needed for a successful technical transfer and launch.

• Delivering clinical through to commercial solids drug product supply from the manufacturing site ensuring manufacturing performance cost and process robustness requirements are met

• Influences at all organizational levels ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate optimally in a multidimensional work environment and collaborate with multi-functional teams

• Own the estimation Supply Chain resource requirements for assigned projects and ensure proactive technical status communications to leadership

Qualifications

Education:

• Minimum of a bachelors degree is required; advanced degree preferred in a Scientific or Engineering field such as Chemistry Pharmaceutics or Chemical Engineering

• Project Management Certifications is preferred

Experience and Skills:

Required:

• At least 6 years of relevant work experience in the development or manufacturing arena focusing on solids drug product.

• 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 moderate to large 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

• Business Approach: negotiation and sourcing strategies and financial impact (e.g. finance for non-financial professionals)

• Decision making and problem-solving: able to seek solutions to complicated problems independently or through others and develops recommendations or build solutions

• Investigation handling and statistical assessments supporting Continued Process Verification ensuring robust processes

Preferred:

• Knowledge of contract manufacturing activities and crafting working relationships with global external partners.

• International experience and interest in collaborating with various cultures / nationalities / perspectives.

• 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 chemical synthesis know-how knowledge and willingness for peptide Oligonucleotide and conjugate know-how is an advantage

Other:

• Proficient in English written and spoken

• Availability to work in an international environment across different time zones

• International and domestic travel up to 30% - project dependent - is required

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.