19 days old

Project Manager - Biosimilars

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114881129
Amgen

Job ID: R-86016
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Project Manager - Biosimilars to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

The Project Manager will work in the Biosimilars Business Unit PD/Operation group,responsible for analytical similarity sample management of biosimilar programs to commercialization.

Responsibilities :
  • Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval
  • Assist with process development initiatives to meet internal needs
  • Maintain awareness of regulatory environment and keep abreast of regulatory requirements that affect work projects
  • Provide project management of biosimilar business unit (BBU) analytical similarity sample management.
  • Collaborate closely with cross-functional team including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory.
  • Coordinate distribution of samples for testing and communicate incoming data for biosimilar projects.
  • Lead cross-functional bi-weekly sample management meeting with BBU PD and CRG.
  • Provide forecast to assist in sample and resource planning regularly.
  • Create electronic laboratory notebooks (ELN) for sample submission.
  • Generate lot number, sample ID, retrieving data and occasionally data entry and data authorization in QC LIMS.
  • Assist BBU staff with navigating ELN software and placing work orders for ELN updates. Database queries of LIMS, ELN and other databases including the compiling and organizing data to review, verify independently or in coordination with Data Management.
  • Retrieving and organizing data for review with Similarity Team and Data Management
  • Contributing to internal presentations, INDs, Marketing Applications and authoring of analytical biosimilar quarterly updates.
  • Provide data verification as needed for internal documents and regulatory filings in controlled document system.


Basic Qualifications :

Doctorate Degree

OR

Master's Degree and at least 3 years relevant experience

OR

Bachelor's Degree and 5 years relevant experience

OR

Associate's degree and 10 years of relevant experience

OR

High school diploma / GED and 12 years of relevant experience

Preferred Qualifications :

Bachelor's or Master's degree in life science, statistics, biostatistics, and/or computer sciences.

Excellent project management skills

Excellent oral and written communication skills

Lab experience in a biotech company

Experience in the development of biosimilar candidates

Technical writing experience or experience working on regulatory documents (INDs or marketing applications, etc.)

Good knowledge and experience with time management and timeline development

Pays attention to detail

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages 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.

PI114881129

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86016<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Project Manager - Biosimilars</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>The <b>Project Manager</b> will work in the Biosimilars Business Unit PD/Operation group,responsible for analytical similarity sample management of biosimilar programs to commercialization.<br><br><b> Responsibilities </b>:<br><ul><li> Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval </li><li> Assist with process development initiatives to meet internal needs </li><li> Maintain awareness of regulatory environment and keep abreast of regulatory requirements that affect work projects </li><li>Provide project management of biosimilar business unit (BBU) analytical similarity sample management.</li><li>Collaborate closely with cross-functional team including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory.</li><li>Coordinate distribution of samples for testing and communicate incoming data for biosimilar projects. </li><li>Lead cross-functional bi-weekly sample management meeting with BBU PD and CRG. </li><li>Provide forecast to assist in sample and resource planning regularly.</li><li>Create electronic laboratory notebooks (ELN) for sample submission.</li><li>Generate lot number, sample ID, retrieving data and occasionally data entry and data authorization in QC LIMS.</li><li>Assist BBU staff with navigating ELN software and placing work orders for ELN updates. Database queries of LIMS, ELN and other databases including the compiling and organizing data to review, verify independently or in coordination with Data Management.</li><li>Retrieving and organizing data for review with Similarity Team and Data Management</li><li>Contributing to internal presentations, INDs, Marketing Applications and authoring of analytical biosimilar quarterly updates.</li><li>Provide data verification as needed for internal documents and regulatory filings in controlled document system.</li></ul><br><br><b> Basic Qualifications </b><b> : </b><br><br> Doctorate Degree <br><br> OR <br><br> Master's Degree and at least 3 years relevant experience <br><br> OR <br><br> Bachelor's Degree and 5 years relevant experience <br><br>OR<br><br>Associate's degree and 10 years of relevant experience<br><br>OR<br><br>High school diploma / GED and 12 years of relevant experience<br><br><b> Preferred Qualifications </b><b> : </b><br><br> Bachelor's or Master's degree in life science, statistics, biostatistics, and/or computer sciences. <br><br> Excellent project management skills <br><br> Excellent oral and written communication skills <br><br> Lab experience in a biotech company <br><br> Experience in the development of biosimilar candidates <br><br> Technical writing experience or experience working on regulatory documents (INDs or marketing applications, etc.) <br><br> Good knowledge and experience with time management and timeline development <br><br> Pays attention to detail <br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br><b> Amgen </b> focuses on areas of high unmet medical needs and leverages 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/QlJr28ieEXBaSV65ioraQ"> <p>PI114881129</p>

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

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Project Manager - Biosimilars

Amgen
Thousand Oaks, CA 91360

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