10 days old

Process Development Scientist - New Product Introduction

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    115348076
Amgen

Job ID: R-78642
Location: Juncos, PR, US 00777

The Process Development Scientist will conceive, design, implement and execute, which contribute to the successful completion of goals and/or projects under general mentorship of supervisor. Under minimal supervision will executes and interprets strategies, lead new processes to transfer successfully to the plant and ensures that projects are implemented in compliance with the respective guidelines and regulations

This role will be reporting to an administrative work schedule with the flexibility to support the non-standard shift organization, as per business needs. The role is essential for Amgen's success and will be a key contributor in the Process Development-Drug Product organization.

The role

After the completion of the on-boarding and applicable training/qualifications; you will join a team focused on development and leading projects to support new product launches, tech transfers and business cases which allow us products portfolio expansion impacting more patient's lives every day. The primary focus will be in drug product, inspected drug product and finished drug product manufactured at AML. This is an outstanding opportunity to support advancing our pipeline and transforming Amgen for the future.

The department

The AML Process Development Drug Product team provides cross-functional support to AML's drug product operations. In addition to supporting local manufacturing to the AML facility, the team also serves as liaison with multi-disciplinary teams from the network. We are a highly committed team that utilizes our strength by achieving of our role of driving innovation centered on advancing the Amgen mission to serve patients.

Specific responsibilities included but are not limited to:
  • Develops and follows timelines for completing project team work.
  • Designs, monitors or conducts strategies or projects which significantly contribute to attaining high priority goals.
  • Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
  • Conceive plans and conduct investigation in areas of considerable scope and complexity.
  • Provides data analysis and interpretation, and assesses impact of the data on the project
  • Establish leads and/or participate in technical forums for sharing of best practices and application of filling process expertise
  • Support and lead technology transfer projects for the filling operations. Prompt and regular attendance to workplace
  • May introduce advanced technology or processes.
  • Develops and implements new and novel process to address specific issues
  • May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications.
  • May represent the department on project teams
  • May initiate productive collaborations within and outside of the department or company.
  • Independently authors summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • May develop supervisory and mentoring skills.
  • Interacts effectively with variety of communication and working styles
  • Be flexible to support extended hour, non-standard shifts and handle changes.


Basic qualifications:

Doctorate degree

Or

Master's degree and 3 years of Process Development and/or Technical Services experience in GMP regulated industry

Or

Bachelor's degree and 5 years of Process Development and/or Technical Services experience in GMP regulated industry

Preferred qualifications are:
  • Education discipline in Life Sciences and/or Engineering
  • Experience with parenteral, process validation, process monitoring and/or process qualifications.
  • Working knowledge of pharmaceutical/biotech processes.
  • Familiarity with documentation in a highly regulated environment.
  • Ability to interpret and apply GLP's and GMPs.
  • Ability to apply science to production.
  • Able to develop solutions to routine technical problems of limited scope.
  • Knowledge of validation processes and requirements as applied to new equipment installations
  • Be organized, have multi-task project experience and be able to communicate & work well with other functional areas
  • Skills in the following areas:
  • Verbal communication (English / Spanish)
  • Problem solving
  • Written communication including technical writing skills (English / Spanish)
  • Project management
  • Negotiation, persuasion and facilitation
  • Collaboration
  • Conflict Resolution
  • Leadership and team building
  • Computer literacy (Windows environment: Project, Word, Excel, Power Point).
  • Fully bilingual (English/Spanish)


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI115348076

<b>Amgen</b><br/><br/><b>Job ID: </b>R-78642<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>The Process Development Scientist will conceive, design, implement and execute, which contribute to the successful completion of goals and/or projects under general mentorship of supervisor. Under minimal supervision will executes and interprets strategies, lead new processes to transfer successfully to the plant and ensures that projects are implemented in compliance with the respective guidelines and regulations<br><br>This role will be reporting to an administrative work schedule with the flexibility to support the non-standard shift organization, as per business needs. The role is essential for Amgen's success and will be a key contributor in the Process Development-Drug Product organization.<br><br><b>The role</b><br><br>After the completion of the on-boarding and applicable training/qualifications; you will join a team focused on development and leading projects to support new product launches, tech transfers and business cases which allow us products portfolio expansion impacting more patient's lives every day. The primary focus will be in drug product, inspected drug product and finished drug product manufactured at AML. This is an outstanding opportunity to support advancing our pipeline and transforming Amgen for the future.<br><br><b>The department</b><br><br>The AML Process Development Drug Product team provides cross-functional support to AML's drug product operations. In addition to supporting local manufacturing to the AML facility, the team also serves as liaison with multi-disciplinary teams from the network. We are a highly committed team that utilizes our strength by achieving of our role of driving innovation centered on advancing the Amgen mission to serve patients.<br><br><b>Specific responsibilities included but are not limited to:</b><br><ul><li>Develops and follows timelines for completing project team work.</li><li>Designs, monitors or conducts strategies or projects which significantly contribute to attaining high priority goals.</li><li>Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.</li><li>Conceive plans and conduct investigation in areas of considerable scope and complexity.</li><li>Provides data analysis and interpretation, and assesses impact of the data on the project</li><li>Establish leads and/or participate in technical forums for sharing of best practices and application of filling process expertise</li><li>Support and lead technology transfer projects for the filling operations. Prompt and regular attendance to workplace</li><li>May introduce advanced technology or processes.</li><li>Develops and implements new and novel process to address specific issues</li><li>May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications.</li><li>May represent the department on project teams</li><li>May initiate productive collaborations within and outside of the department or company.</li><li>Independently authors summary documents, complex regulatory documents, invention disclosure submissions and/or patents.</li><li>May develop supervisory and mentoring skills.</li><li>Interacts effectively with variety of communication and working styles</li><li>Be flexible to support extended hour, non-standard shifts and handle changes.</li></ul><br><br><b>Basic qualifications:</b><br><br>Doctorate degree<br><br>Or<br><br>Master's degree and 3 years of Process Development and/or Technical Services experience in GMP regulated industry<br><br>Or<br><br>Bachelor's degree and 5 years of Process Development and/or Technical Services experience in GMP regulated industry<br><br><b>Preferred qualifications are:</b><br><ul><li>Education discipline in Life Sciences and/or Engineering</li><li>Experience with parenteral, process validation, process monitoring and/or process qualifications.</li><li>Working knowledge of pharmaceutical/biotech processes.</li><li>Familiarity with documentation in a highly regulated environment.</li><li>Ability to interpret and apply GLP's and GMPs.</li><li>Ability to apply science to production.</li><li>Able to develop solutions to routine technical problems of limited scope.</li><li>Knowledge of validation processes and requirements as applied to new equipment installations</li><li>Be organized, have multi-task project experience and be able to communicate & work well with other functional areas</li><li>Skills in the following areas:</li><li>Verbal communication (English / Spanish)</li><li>Problem solving</li><li>Written communication including technical writing skills (English / Spanish)</li><li>Project management</li><li>Negotiation, persuasion and facilitation</li><li>Collaboration</li><li>Conflict Resolution</li><li>Leadership and team building</li><li>Computer literacy (Windows environment: Project, Word, Excel, Power Point).</li><li>Fully bilingual (English/Spanish)</li></ul><br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/g2oRA7U7D2J1hxaAIlr4k"> <p>PI115348076</p>

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Posted: 2019-11-09 Expires: 2019-12-10

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Process Development Scientist - New Product Introduction

Amgen
Juncos, Puerto Rico 00777

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