At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

The Biologics Clinical Operations External Partnerships (BCO EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The MCO intern will contribute to the overall development, implementation, and execution of clinical manufacturing activities at the Malvern site. They will work closely with assigned personnel on Tech Transfers of New Product Introductions (NPI’s), support new and existing projects and process improvements, support cost reduction efforts, and assist in on the floor support of DS manufacturing.

Objectives Responsibilities:

Establish and demonstrate an understanding of current Good Manufacturing Practices (cGMP) requirementsEstablish and demonstrate an understanding of the clinical DS manufacturing process Establish and demonstrate an understanding of basic project management skills including development of a project scope, schedule, resourcing, and costsDemonstrate an understanding of justifications required to support project proposalsAssist in equipment/system/process monitoring and troubleshooting efforts Participate in process fit to plant assessments, project kickoff meetings, and core team meetings to understand technology transfer of New Product Introduction (NPI) Develop/modify departmental Standard Operating Procedures (SOPs) and best practices Lead/support implementation of process improvementsSupport review of design documentation, specifications, and related documents as they relate to equipment design and validation Assist in process and equipment startup and training within the MCO organizationEstablish and demonstrate solid communication and collaboration skills across functionsSupport a one team culture

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

The Biologics Clinical Operations External Partnerships (BCO EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The MCO intern will contribute to the overall development, implementation, and execution of clinical manufacturing activities at the Malvern site. They will work closely with assigned personnel on Tech Transfers of New Product Introductions (NPI’s), support new and existing projects and process improvements, support cost reduction efforts, and assist in on the floor support of DS manufacturing.

Objectives Responsibilities:

Establish and demonstrate an understanding of current Good Manufacturing Practices (cGMP) requirementsEstablish and demonstrate an understanding of the clinical DS manufacturing process Establish and demonstrate an understanding of basic project management skills including development of a project scope, schedule, resourcing, and costsDemonstrate an understanding of justifications required to support project proposalsAssist in equipment/system/process monitoring and troubleshooting efforts Participate in process fit to plant assessments, project kickoff meetings, and core team meetings to understand technology transfer of New Product Introduction (NPI) Develop/modify departmental Standard Operating Procedures (SOPs) and best practices Lead/support implementation of process improvementsSupport review of design documentation, specifications, and related documents as they relate to equipment design and validation Assist in process and equipment startup and training within the MCO organizationEstablish and demonstrate solid communication and collaboration skills across functionsSupport a one team culture

Education:

Pursuing a B.S. degree in Engineering or Biotechnology or Pharmaceutical SciencesTechnical Skill and Knowledge: Strong computer and technical writing skillsSkilled with Microsoft Office Suite of productsAbility to improve websites, SharePoint's, and Microsoft Teams communication platforms Ability to author routine reports and correspondenceAbility to speak effectively before groups of employees of the organizationAbility to define problems, collect data, establish facts, and draw valid conclusions

General:

Ability and willingness to work effectively and efficiently with appropriate supervision while maintaining control over current projects and responsibilitiesEagerness to learn and apply project management tools to lead projects and programsPermanent US work authorization without the need for sponsorship now, or in the future (F1 or H1B requires sponsorship in future)Have a cumulative GPA of 3.0 or higher, which is reflective of all college coursework

Schedule:

Standard Mon-Fri business scheduleMay be requested to work off shift in rare instances for special project/manufacturing supportThe position is located in Malvern, Pennsylvania

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 on the basis of disability.
 
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

Education:

Pursuing a B.S. degree in Engineering or Biotechnology or Pharmaceutical SciencesTechnical Skill and Knowledge: Strong computer and technical writing skillsSkilled with Microsoft Office Suite of productsAbility to improve websites, SharePoint's, and Microsoft Teams communication platforms Ability to author routine reports and correspondenceAbility to speak effectively before groups of employees of the organizationAbility to define problems, collect data, establish facts, and draw valid conclusions

General:

Ability and willingness to work effectively and efficiently with appropriate supervision while maintaining control over current projects and responsibilitiesEagerness to learn and apply project management tools to lead projects and programsPermanent US work authorization without the need for sponsorship now, or in the future (F1 or H1B requires sponsorship in future)Have a cumulative GPA of 3.0 or higher, which is reflective of all college coursework

Schedule:

Standard Mon-Fri business scheduleMay be requested to work off shift in rare instances for special project/manufacturing supportThe position is located in Malvern, Pennsylvania

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 on the basis of disability.
 
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.