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Process Development Principal Scientist - Cambridge, MA
VetJobs, Cambridge, Massachusetts, us, 02140
Process Development Principal Scientist - Cambridge, MA
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Process Development Principal Scientist - Cambridge, MA
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VetJobs Process Development Principal Scientist - Cambridge, MA
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Process Development Principal Scientist - Cambridge, MA
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VetJobs Job Description
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Principal Scientist
What you will do
Skills
Let’s do this. Let’s change the world. In this vital role you will apply your knowledge and skills to perform analytical development of late-stage biological therapeutics. In your daily work you will:
Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.
Provide analytical testing support to functions including but not limited to Drug Substance Technologies, Quality, and Manufacturing
Leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods
Design and execute analytical studies to support process and product characterization for late-stage development products utilizing protein chemistry, separation sciences and mass spectrometry
Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents
Lead project teams and/or project sub-teams to meet program goals
Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Auto req ID
451992BR
Minimum Education Required
Bachelors
Job_Category
Scientific Research & Development
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications.
Basic Qualifications
Bachelor’s degree and 7 years of Scientific experience; Or
Master’s degree and 5 years of Scientific experience; Or
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience
Preferred Qualifications
Advanced degree in Analytical Chemistry or related area with extensive experience performing independent scientific research
Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Strong and in-depth expertise in multiple analytical techniques (i.e., SE-HPLC, icIEF, IEX-HPLC, RP-HPLC, CE-SDS, LC-MS); characterization of protein modifications with glycan mapping and peptide mapping.
Experience in method development, qualification, transfer, troubleshooting, method validation, and complex investigations.
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing for and responding to RTQ, including assessment of CQAs, product quality targets and attribute risk assessment.
Strong oral and verbal communication skills, ability to interact effectively with diverse internal and external stakeholders.
Demonstrated leadership abilities including people-centric leadership and the ability to lead in a matrix environment.
Proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, ability to multitask, effectively plan and follow through on complex projects.
A self-starter with strong decision-making skills, who thrives in collaborative matrix environment and can provide cross-functional leadership and mentorship to junior staff.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range
148,363.00 USD - 171,657.00 USD
City*
Cambridge
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000 Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at VetJobs by 2x Get notified about new Process Development Scientist jobs in
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join to apply for the
Process Development Principal Scientist - Cambridge, MA
role at
VetJobs Process Development Principal Scientist - Cambridge, MA
3 days ago Be among the first 25 applicants Join to apply for the
Process Development Principal Scientist - Cambridge, MA
role at
VetJobs Job Description
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Principal Scientist
What you will do
Skills
Let’s do this. Let’s change the world. In this vital role you will apply your knowledge and skills to perform analytical development of late-stage biological therapeutics. In your daily work you will:
Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.
Provide analytical testing support to functions including but not limited to Drug Substance Technologies, Quality, and Manufacturing
Leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods
Design and execute analytical studies to support process and product characterization for late-stage development products utilizing protein chemistry, separation sciences and mass spectrometry
Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents
Lead project teams and/or project sub-teams to meet program goals
Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Auto req ID
451992BR
Minimum Education Required
Bachelors
Job_Category
Scientific Research & Development
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications.
Basic Qualifications
Bachelor’s degree and 7 years of Scientific experience; Or
Master’s degree and 5 years of Scientific experience; Or
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience
Preferred Qualifications
Advanced degree in Analytical Chemistry or related area with extensive experience performing independent scientific research
Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Strong and in-depth expertise in multiple analytical techniques (i.e., SE-HPLC, icIEF, IEX-HPLC, RP-HPLC, CE-SDS, LC-MS); characterization of protein modifications with glycan mapping and peptide mapping.
Experience in method development, qualification, transfer, troubleshooting, method validation, and complex investigations.
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing for and responding to RTQ, including assessment of CQAs, product quality targets and attribute risk assessment.
Strong oral and verbal communication skills, ability to interact effectively with diverse internal and external stakeholders.
Demonstrated leadership abilities including people-centric leadership and the ability to lead in a matrix environment.
Proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, ability to multitask, effectively plan and follow through on complex projects.
A self-starter with strong decision-making skills, who thrives in collaborative matrix environment and can provide cross-functional leadership and mentorship to junior staff.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range
148,363.00 USD - 171,657.00 USD
City*
Cambridge
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000 Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at VetJobs by 2x Get notified about new Process Development Scientist jobs in
Cambridge, MA . Cambridge, MA $112,000.00-$130,000.00 6 hours ago Senior Research Scientist - Energy Systems and Business Analysis
Cambridge, MA $180,000.00-$270,000.00 4 days ago Framingham, MA $84,000.00-$121,333.33 2 weeks ago Clinical Scientist, Clinical Development
Waltham, MA $140,000.00-$155,000.00 1 month ago Boston, MA $150,400.00-$260,000.00 2 weeks ago Senior Scientist, Drug Substance Development and Manufacturing
Greater Boston $115,000.00-$140,000.00 2 weeks ago Process Development Senior Scientist – Synthetics Analytical Chemistry
Framingham, MA $100,500.00-$145,166.66 2 weeks ago Associate Scientist, Process Development - Pivotal Drug Product
Woburn, MA $130,000.00-$190,000.00 1 week ago Scientist/Senior Scientist, Chemical Development and Manufacturing
Principal Scientist , Analytical Science Lead
Waltham, MA $160,000.00-$190,000.00 1 week ago Senior Scientist, Analytical Development
Associate Scientist Analytical Development - Early Development
Cambridge, MA $99,500.00-$156,420.00 5 days ago Clinical-Scientific - Analytical Chemist
Clinical-Scientific - Analytical Chemist Analytical Chemist
Associate Scientist, Process Development - Pivotal Drug Product
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr