Drug Product Technical Launch Integrator at Johnson & Johnson

Gurabo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, MedTechIndustries

Requirements

Expertise in Drug Product Process technical support and oversight for the supply chain
Ability to collaborate with R&D, commercial manufacturing sites (internal or external), Supply Chain, Value Chain Team (VCT), Site operational teams, CMC Sub teams, and R&D SI sub teams
Knowledge of Best Process at Launch (BPAL), Best-Product-At-Launch, and Quality-by-Design principles
Experience in pharmaceutical process development, transfer, and commercial readiness
Capability to work in a hybrid position, primarily in Gurabo, PR (alternative: Latina, IT)
Leadership skills as a People Leader in R&D Process Engineering

Responsibilities

Facilitate commercial site technical support during execution of transfer activities
Ensure incorporation of technical expertise, including 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, ensuring alignment and endorsement within the sites and TLI function for Supply Chain MSAT
Provide required manufacturing site-based technical support, technical documentation input, review, and approval
Serve as a member of Supply Chain, Value Chain Team (VCT), Site operational teams, and lead the new product introduction team at the sites
Act as a full member of several R&D teams, CMC Sub teams, and R&D SI sub teams to optimally develop and transfer to the commercial launch site, with focus on drug product within the Synthetic Platform

Skills

R&D Product Development

R&D Process Engineering

Technical Launch Integration

Drug Product Development

Pharmaceutical Manufacturing

Project Management

Process Engineering

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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