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Job Description:

At Johnson & Johnson we believe good health is the foundation of vibrant lives thriving communities and forward progress. Thats why for more than 130 years we have sought to keep people well at every age and every stage of life. Today as the worlds largest and most broadly based healthcare company we are committed to using our reach and size for good. We strive to improve access and affordability build healthier communities and put a healthy mind body and environment within reach of everyone everywhere. Every day our more than 130000 employees across the world are blending heart science and resourcefulness to profoundly change the trajectory of health for humanity.

Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain (Supply Chain) a member of Johnson & Johnsons Family of Companies we are excited to recruit a Technical Launch Integrator (TLI) in the Emerging Synthetics group with the primary location in Belgium.

Would you like to be a part of our 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 strong collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed and successfully transferred considering Best Process at Launch (BPAL) principles.

Areas of key responsibility include API technical support and oversight for the supply chain.

As a TLI you will be a member of the Supply Chain Value Chain Team (VCT) Site operational teams and lead the new product introduction team at internal and external 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 successfully develop and transfer to the commercial launch site (internal or external).

The focus of this TLI position is on API and on Emerging Synthetics like ADCs peptides and oligonucleotides within the Synthetics Platform.

Key Responsibilities:

• Act as lead (and/or support the lead TLI ) MSAT point of contact for Supply Chain ensuring fit for lant and plant readiness for technical transfer to commercial operations.

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

• Ensure incorporation of Supply Chain 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 Supply Chain and R&D.

• Evaluate thoroughly the BPAL (Best Product & Process at Launch) information

• Support the MSAT Technical Review Process.

• Contribute to review and approve regulatory documents for global markets.

• Represent the manufacturing sites on the CMC R&D Sub-team and the VCT.

• Partner with R&D and Supply Chain to identify and implement opportunities for active decrease in COGs and ensure fit for plant and commercial robustness of new products.

• 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 manufacturing site 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 manufacturing sites and TLI function of Supply Chain MSAT.

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

• 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 API/SDP 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 effectively 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 with an Advanced degree preferred in a Scientific or Engineering field such as Chemistry Pharmaceutics or Chemical Engineering with at least 10 years of relevant work experience in the development or manufacturing area focusing on API with experience in DP as an advantage.

Experience and Skills:

Required:

• Broad proven technical background in API Chemical manufacturing process & product development quality cGMP and regulatory knowledge related to Small Molecules
• Strong communication skills and effective communication 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
• Eye for business: negotiation and sourcing strategies and financial impact (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 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.
• Partial experience in Drug Products.
• Knowledge of contract manufacturing activities and crafting working relationships with global external partners.
• Capability to influences others with shared or different interests often beyond scope and level networking convincing priority setting both internally and externally.
• Besides excellent chemical synthesis know-how knowledge and willingness for peptide oligonucleotide and drug conjugate know-how are advantages.
  

Other:

• Proficient in written and spoken English

• Works in an international environment across different time zones

• Project management certifications preferred

• International and domestic travel up to 25% - project dependent

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against based on disability.

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