1+ months

Senior Manager Process Development

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116405733
Amgen

Job ID: R-89926
Location: Thousand Oaks, CA, US 91360

The Amgen External Process Development (XPD) organization is seeking a highly qualified Sr Mgr Process Development to lead early stage synthetic drug substance outsourcing. The Senior Manager will be responsible for overseeing a portfolio of externally placed projects delivering developmental data, toxicology and early clinical material. Across a range of synthetic programs, the role will develop an outsourcing strategy with clients, establish key partnership with vendors, execute projects both developmental and routine in nature to advance Amgen's synthetic pipeline. Lead a team of talented individuals in sourcing development and production of raw materials, starting materials, intermediates and drug substance. Partner with internal development groups to advance Amgen's synthetic pipeline from R&D to the clinic.

Process Development is responsible for enabling commercialization of the product pipeline, product lifecycle management, and technical manufacturing support of Amgen commercial products. The External Process Development group was created to develop PD's sourcing strategy and drive the implementation across the development portfolio.

We are seeking a dynamic and highly motivated individual to join the External Process Development group. The successful candidate will have experience working with CRO/CMO's, and a strong understanding of drug development, commercialization, and business management. He/ She will apply this knowledge to lead the implementation of sourcing initiatives and manage a variety of external projects engaging domestic, international, and emerging market suppliers. This person will establish a strong partnership across all PD functions and with our key business partners to deliver success. Along with key business partners and functional groups this person will focus on making effective recommendations to Process Development senior leadership team. The successful candidate will also lead and manage teams to advance Process Development objectives.

Domestic and International travel expected.

Responsibilities:
  • Identify and establish needed capabilities regarding synthetic execution and development
  • Develop and execute XPD synthetic outsourcing strategy with internal clients
  • Oversee execution of XPD synthetic projects at multiple vendors
  • Supplier evaluation and selection
  • Establish and maintain external collaborations, develop SOWs, manage purchase orders and associated budget for externalization activities
  • Monitor performance to continuously improve efficiency and effectiveness of suppliers
  • Manage spend and adhere to financial targets and systems
  • Supervise staff
  • Engage with various R&D and operations functions to advance specific projects in the portfolio
  • Ensure programs meet compliance, speed, quality, and cost
  • Presentation of analyses and recommendations to Senior Management


Basic Qualifications:

Doctorate degree and 2 years engineering, science or business management experience

OR

Master's degree and 4 years engineering, science or business management experience

OR

Bachelor's degree and 6 years engineering, science or business management experience

OR

Associate degree and 10 years engineering, science or business management experience

OR

High school diploma / GED and 12 years engineering, science or business management experience

Preferred Qualifications:
  • Demonstrated understanding of development and commercialization for synthetic therapeutics
  • Demonstrated experience with crystallization, catalysis, rout scouting, impurity synthesis, API production, process development and process characterization
  • Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
  • Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
  • Strong quantitative and qualitative skills including financial analysis, cost accounting, and product lifecycle management
  • Demonstrated understanding of pharmaceutical development and manufacturing
  • Strong writing and presentation skills
  • Strong interpersonal and influencing skills with a demonstrated ability to drive decisions
  • Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
  • Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need 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.

PI116405733

<b>Amgen</b><br/><br/><b>Job ID: </b>R-89926<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Amgen External Process Development (XPD) organization is seeking a highly qualified Sr Mgr Process Development to lead early stage synthetic drug substance outsourcing. The Senior Manager will be responsible for overseeing a portfolio of externally placed projects delivering developmental data, toxicology and early clinical material. Across a range of synthetic programs, the role will develop an outsourcing strategy with clients, establish key partnership with vendors, execute projects both developmental and routine in nature to advance Amgen's synthetic pipeline. Lead a team of talented individuals in sourcing development and production of raw materials, starting materials, intermediates and drug substance. Partner with internal development groups to advance Amgen's synthetic pipeline from R&D to the clinic.<br><br>Process Development is responsible for enabling commercialization of the product pipeline, product lifecycle management, and technical manufacturing support of Amgen commercial products. The External Process Development group was created to develop PD's sourcing strategy and drive the implementation across the development portfolio.<br><br>We are seeking a dynamic and highly motivated individual to join the External Process Development group. The successful candidate will have experience working with CRO/CMO's, and a strong understanding of drug development, commercialization, and business management. He/ She will apply this knowledge to lead the implementation of sourcing initiatives and manage a variety of external projects engaging domestic, international, and emerging market suppliers. This person will establish a strong partnership across all PD functions and with our key business partners to deliver success. Along with key business partners and functional groups this person will focus on making effective recommendations to Process Development senior leadership team. The successful candidate will also lead and manage teams to advance Process Development objectives.<br><br>Domestic and International travel expected.<br><br>Responsibilities:<br><ul><li>Identify and establish needed capabilities regarding synthetic execution and development</li><li>Develop and execute XPD synthetic outsourcing strategy with internal clients</li><li>Oversee execution of XPD synthetic projects at multiple vendors</li><li>Supplier evaluation and selection</li><li>Establish and maintain external collaborations, develop SOWs, manage purchase orders and associated budget for externalization activities</li><li>Monitor performance to continuously improve efficiency and effectiveness of suppliers</li><li>Manage spend and adhere to financial targets and systems</li><li>Supervise staff</li><li>Engage with various R&D and operations functions to advance specific projects in the portfolio</li><li>Ensure programs meet compliance, speed, quality, and cost</li><li>Presentation of analyses and recommendations to Senior Management</li></ul><br><br>Basic Qualifications: <br><br>Doctorate degree and 2 years engineering, science or business management experience<br><br>OR<br><br>Master's degree and 4 years engineering, science or business management experience<br><br>OR<br><br>Bachelor's degree and 6 years engineering, science or business management experience<br><br>OR<br><br>Associate degree and 10 years engineering, science or business management experience<br><br>OR<br><br>High school diploma / GED and 12 years engineering, science or business management experience<br><br>Preferred Qualifications: <br><ul><li>Demonstrated understanding of development and commercialization for synthetic therapeutics</li><li>Demonstrated experience with crystallization, catalysis, rout scouting, impurity synthesis, API production, process development and process characterization</li><li>Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies</li><li>Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences</li><li>Strong quantitative and qualitative skills including financial analysis, cost accounting, and product lifecycle management</li><li>Demonstrated understanding of pharmaceutical development and manufacturing</li><li>Strong writing and presentation skills</li><li>Strong interpersonal and influencing skills with a demonstrated ability to drive decisions</li><li>Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems</li><li>Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need 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/z14y6eIOenVlU7oqibe5x"> <p>PI116405733</p>

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Posted: 2019-12-17 Expires: 2020-01-17

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Senior Manager Process Development

Amgen
Thousand Oaks, CA 91360

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