27 days old

Senior Validation Scientist - AML6 Drug Substance

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    114880011
Amgen

Job ID: R-86001
Location: Juncos, PR, US 00777

Are you looking for a challenging new opportunity to test and growth your validation skills? We have an immediate need for a Sr Validation Scientist to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The role

If you're the right person for this opportunity you will have a passion for mechanical design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams.

As Sr Validation Scientist you will have a meaningful role for AML6 facility by leading the Validation activities. In addition, you will ensure that all activities are completed on time while meeting safety, quality, and financial objectives.

You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or engineering projects of significant scope and complexity. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.

Independently provides and/or directs the technical validation support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity

Specific responsibilities include but are not limited to:

  • Complete complex or novel assignments requiring development of new and/or improved process validation techniques and procedures.
  • Develop process validation policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced process validation techniques and/or modifications of advanced techniques within area of process validation expertise.
  • Apply knowledge of process validation principles and practices outside of area of expertise to broad variety of assignments in related fields.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
  • Work with project managers to complete the process validation responsibilities of technology transfer and commercial operation projects within schedule, budget and quality constraints.
  • Prompt and regular attendance to the workplace.
  • Be flexible to support extended hour, non-standard shifts and manage changes.
  • Applies extensive technical process validation expertise, and has full knowledge of other related disciplines.
  • Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
  • Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
  • Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
  • Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • May be expected to directly supervise staff or project resources.
  • Represents the organization as the prime process validation technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
  • Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
  • Represents the organization as the technical expert to endorse the organization's process validation program and practices.
  • Interacts effectively with variety of communication and working styles.


The department

The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world

Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support Amgen's mission. If you have growth mindset and you thrive under pressure, you are probably a great fit for our team!

Basic Qualifications

Doctorate degree
or
Master's degree and 3 years of validation and/or scientific experience in GMP regulated industry
or
Bachelor's degree and 5 years of validation and/or scientific experience in GMP regulated industry

Additional Preferred Qualifications are:

  • Education discipline/background in Life Sciences and/or Engineering.
  • Experience in commissioning and qualification following Risk and Science Based approaches per ISPE Baseline Guide, GAMP and ASTM E2500 within a GMP regulated industry
  • Able to explain CQV lifecycle of manufacturing systems to internal / external auditors
  • Understanding of the biologic drug substance manufacturing processes (cell culture/fermentation, chromatography, filtration and separation processes) and the application following ICH Q7 guidance
  • Fully bilingual (English/Spanish).
  • Advanced scientific analysis, troubleshooting and laboratory work skills.
  • Ability to handle multiple projects at one time.
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
  • Skills in the following areas:
    • Schedule development
    • Facilitation
    • Collaboration
    • Basic project management
    • Completion and follow-up
    • Negotiation, persuasion and facilitation
    • Collaboration
    • Project cost development
    • Conflict Resolution
    • Decision Making
    • Leadership and teambuilding
    • Management of contractors and vendors


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

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.

PI114880011

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86001<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>Are you looking for a challenging new opportunity to test and growth your validation skills? We have an immediate need for a Sr Validation Scientist to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.<br><br><b>The role</b><br><br>If you're the right person for this opportunity you will have a passion for mechanical design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams.<br><br>As Sr Validation Scientist you will have a meaningful role for AML6 facility by leading the Validation activities. In addition, you will ensure that all activities are completed on time while meeting safety, quality, and financial objectives.<br><br>You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or engineering projects of significant scope and complexity. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.<br><br>Independently provides and/or directs the technical validation support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity<br><br><b>Specific responsibilities include but are not limited to:</b><br><br><ul><li>Complete complex or novel assignments requiring development of new and/or improved process validation techniques and procedures.</li><li>Develop process validation policies and procedures that affect multiple organizational units.</li><li>Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.</li><li>Employ advanced process validation techniques and/or modifications of advanced techniques within area of process validation expertise.</li><li>Apply knowledge of process validation principles and practices outside of area of expertise to broad variety of assignments in related fields.</li><li>Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.</li><li>Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.</li><li>Work with project managers to complete the process validation responsibilities of technology transfer and commercial operation projects within schedule, budget and quality constraints.</li><li>Prompt and regular attendance to the workplace.</li><li>Be flexible to support extended hour, non-standard shifts and manage changes.</li></ul><ul><li>Applies extensive technical process validation expertise, and has full knowledge of other related disciplines.</li></ul><ul><li>Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.</li></ul><ul><li>Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.</li><li> Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters. </li></ul><ul><li>Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.</li></ul><ul><li>Guides the successful completion of major programs and may function in a project leadership role.</li></ul><ul><li> May be expected to directly supervise staff or project resources. </li></ul><ul><li>Represents the organization as the prime process validation technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.</li></ul><ul><li> Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body. </li><li> Represents the organization as the technical expert to endorse the organization's process validation program and practices. </li><li>Interacts effectively with variety of communication and working styles.</li></ul><br><br><b>The department</b><br><br>The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world <br><br>Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support Amgen's mission. If you have growth mindset and you thrive under pressure, you are probably a great fit for our team!<br><br><b>Basic Qualifications</b><br><br>Doctorate degree<br>or<br>Master's degree and 3 years of validation and/or scientific experience in GMP regulated industry<br>or<br>Bachelor's degree and 5 years of validation and/or scientific experience in GMP regulated industry<br><br><b>Additional Preferred Qualifications are:</b><br><br><ul><li>Education discipline/background in Life Sciences and/or Engineering.</li><li>Experience in commissioning and qualification following Risk and Science Based approaches per ISPE Baseline Guide, GAMP and ASTM E2500 within a GMP regulated industry</li><li>Able to explain CQV lifecycle of manufacturing systems to internal / external auditors</li><li>Understanding of the biologic drug substance manufacturing processes (cell culture/fermentation, chromatography, filtration and separation processes) and the application following ICH Q7 guidance</li><li>Fully bilingual (English/Spanish).</li><li>Advanced scientific analysis, troubleshooting and laboratory work skills.</li></ul><ul><li>Ability to handle multiple projects at one time.</li><li>Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.</li><li>Skills in the following areas:<ul><li>Schedule development</li><li>Facilitation</li><li>Collaboration</li><li>Basic project management</li><li>Completion and follow-up</li><li>Negotiation, persuasion and facilitation</li><li>Collaboration</li><li>Project cost development</li><li>Conflict Resolution</li><li>Decision Making</li><li>Leadership and teambuilding</li><li>Management of contractors and vendors</li></ul></li></ul><br><br><b><b>The benefits</b></b><br><br>Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.<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/7eRDaliYlAXeTZ1NF7Y5y"> <p>PI114880011</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Senior Validation Scientist - AML6 Drug Substance

Amgen
Juncos, Puerto Rico 00777

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