27 days old

Senior Manager Pilot Plant, AMA

Amgen
Cambridge, MA 02138
  • Job Code
    115431872
Amgen

Job ID: R-87754
Location: Cambridge, MA, US 02139

The Senior Manager Pilot Plant will lead a team responsible for safe and compliant manufacturing within the Amgen Massachusetts (AMA) Scale-up Laboratory (SUL). The AMA SUL manufactures drug substance in support of product development, lifecycle management, and development/deployment of new manufacturing technologies. This role will have direct reports comprising of an execution team including process and automation engineering functions. This function resides within a larger Amgen Pilot Plant Network reporting up to the same organizational leadership. The Sr. Manager will be responsible for working closely with the other Amgen Pilot Plants to form alignment in business processes and strategies.

The Amgen Cambridge Pilot Plant is largely comprised of single use systems and technologies. The plant is also partially dedicated to evaluating new technologies from vendors to advance development of new product offerings. Science and engineering are the core of this team's function. The successful candidate will be the Pilot Plant's most senior leader on site and will direct plant resources and staff to ensure area and plant execution goals are met, working with Process Development customers to deliver upon highest priorities.

Additional job responsibilities include:

Lead and manage cross functional projects, advance maturity of new technology in preparation for commercialization which is accomplished through collaborating with clinical/commercial plants, drug substance process development, engineering, quality and manufacturing functions

Staff selection, training, oversight, performance evaluations, and development

Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities

Ensures standard operating procedures are accurate for executing unit operations

Utilizes appropriate systems for job duties (eg, SAP, LIMS, etc)

Interacts with business partners and internal/external customers and clients

Identifies and implements process and safety improvements

Assists in the introduction of new products into the facility

Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and investigations.

Communicate production floor and project work at different levels of management

Basic Qualifications:

Doctorate degree and 2 years of Manufacturing or Operations experience

OR

Master's degree and 6 years of Manufacturing or Operations experience

OR

Bachelor's degree and 8 years of Manufacturing or Operations experience

OR

Associate's degree and 10 years of Manufacturing or Operations experience

OR

High school diploma / GED and 12 years of Manufacturing or Operations experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Advanced degree in Life Science, Chemistry or Engineering

A deep understanding of cell culture and purification unit operations, process equipment, automation systems, scheduling and have strong demonstrated leadership capabilities

Demonstrated leadership accomplishments of driving transformational change

Leadership roles across multiple disciplines that either directly manufacture and/or support drug substance manufacturing with demonstrated results of driving improvements in performance, effectively leading cross functional teams and resolving complex technical challenges

Leadership experience within drug substance manufacturing

Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions

Demonstrated technical writing ability

Demonstrated project management and presentation skills

Demonstrated experience with continuous improvement methodologies

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.

PI115431872

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87754<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>The Senior Manager Pilot Plant will lead a team responsible for safe and compliant manufacturing within the Amgen Massachusetts (AMA) Scale-up Laboratory (SUL). The AMA SUL manufactures drug substance in support of product development, lifecycle management, and development/deployment of new manufacturing technologies. This role will have direct reports comprising of an execution team including process and automation engineering functions. This function resides within a larger Amgen Pilot Plant Network reporting up to the same organizational leadership. The Sr. Manager will be responsible for working closely with the other Amgen Pilot Plants to form alignment in business processes and strategies.<br><br>The Amgen Cambridge Pilot Plant is largely comprised of single use systems and technologies. The plant is also partially dedicated to evaluating new technologies from vendors to advance development of new product offerings. Science and engineering are the core of this team's function. The successful candidate will be the Pilot Plant's most senior leader on site and will direct plant resources and staff to ensure area and plant execution goals are met, working with Process Development customers to deliver upon highest priorities.<br><br><b><b>Additional job responsibilities include:</b></b><br><br>Lead and manage cross functional projects, advance maturity of new technology in preparation for commercialization which is accomplished through collaborating with clinical/commercial plants, drug substance process development, engineering, quality and manufacturing functions<br><br>Staff selection, training, oversight, performance evaluations, and development<br><br>Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities<br><br>Ensures standard operating procedures are accurate for executing unit operations<br><br>Utilizes appropriate systems for job duties (eg, SAP, LIMS, etc)<br><br>Interacts with business partners and internal/external customers and clients<br><br>Identifies and implements process and safety improvements<br><br>Assists in the introduction of new products into the facility<br><br>Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and investigations.<br><br>Communicate production floor and project work at different levels of management<br><br><b><b>Basic Qualifications:</b></b><br><br>Doctorate degree and 2 years of Manufacturing or Operations experience<br><br>OR<br><br>Master's degree and 6 years of Manufacturing or Operations experience<br><br>OR<br><br>Bachelor's degree and 8 years of Manufacturing or Operations experience<br><br>OR<br><br>Associate's degree and 10 years of Manufacturing or Operations experience<br><br>OR<br><br>High school diploma / GED and 12 years of Manufacturing or Operations experience<br><br>AND<br><br>2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b><b>Preferred Qualifications:</b></b><br><br>Advanced degree in Life Science, Chemistry or Engineering<br><br>A deep understanding of cell culture and purification unit operations, process equipment, automation systems, scheduling and have strong demonstrated leadership capabilities<br><br>Demonstrated leadership accomplishments of driving transformational change<br><br>Leadership roles across multiple disciplines that either directly manufacture and/or support drug substance manufacturing with demonstrated results of driving improvements in performance, effectively leading cross functional teams and resolving complex technical challenges<br><br>Leadership experience within drug substance manufacturing<br><br>Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions<br><br>Demonstrated technical writing ability<br><br>Demonstrated project management and presentation skills<br><br>Demonstrated experience with continuous improvement methodologies<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/b7QmkXS8b1GjhxEkINmMp"> <p>PI115431872</p>

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Posted: 2019-11-13 Expires: 2019-12-14

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Senior Manager Pilot Plant, AMA

Amgen
Cambridge, MA 02138

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