Amgen Inc. (IR)
Process Development Principal Scientist
Amgen Inc. (IR), Oregon, Illinois, United States, 61061
Process Development Principal Scientist
Location:
US - California - Thousand OaksType:
Full timePosted:
5 Days AgoJob Requisition ID:
R-195570Career Category
OperationsJob Description
HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.What you will do
In this vital role you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid Drug Products.Lead the attribute and analytical aspects of a program in pivotal clinical process development with a focus on drug product development while working cross-functionally within a Product development team.Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization.Lead method transfer and support of cGMP drug product manufacturing activities at internal manufacturing, and contract manufacturing and testing sites.Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities.Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development.Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department.Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies.Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff.What we expect of you
The dynamic professional we seek is an individual with these qualifications:Basic Qualifications:
Bachelor’s degree and 7 years of Scientific experience
ORMaster’s degree and 5 years of Scientific experience
ORDoctorate degree (PhD, PharmD, or MD) and 2 years of Scientific experience.Preferred Qualifications:
Knowledge of analytical method development and testing requirements toward solid oral dosage support.Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques.Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements.Hands-on experience in development, validation, transfer, and remediation of methods for in-process, release, and stability testing.Knowledge of the major Pharmacopeia and ICH/FDA guidance documents.Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations.Ability to multitask managing deliverables on complex projects against timelines.Strong leadership, problem-solving, decision-making, and communication skills.Excellent technical writing skills and attention to detail in authoring methods, specifications, and regulatory filing documents.What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. is posted. Actual salary will vary based on several factors including relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans, work/life balance, and career development opportunities including:Comprehensive employee benefits package.A discretionary annual bonus program.Stock-based long-term incentives.Award-winning time-off plans.Flexible work models.Apply now
for a career that defies imagination.Amgen does not have an application deadline for this position.Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.Salary Range:
136,662.00 USD - 164,812.00 USD
#J-18808-Ljbffr
Location:
US - California - Thousand OaksType:
Full timePosted:
5 Days AgoJob Requisition ID:
R-195570Career Category
OperationsJob Description
HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.What you will do
In this vital role you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid Drug Products.Lead the attribute and analytical aspects of a program in pivotal clinical process development with a focus on drug product development while working cross-functionally within a Product development team.Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization.Lead method transfer and support of cGMP drug product manufacturing activities at internal manufacturing, and contract manufacturing and testing sites.Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities.Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development.Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department.Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies.Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff.What we expect of you
The dynamic professional we seek is an individual with these qualifications:Basic Qualifications:
Bachelor’s degree and 7 years of Scientific experience
ORMaster’s degree and 5 years of Scientific experience
ORDoctorate degree (PhD, PharmD, or MD) and 2 years of Scientific experience.Preferred Qualifications:
Knowledge of analytical method development and testing requirements toward solid oral dosage support.Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques.Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements.Hands-on experience in development, validation, transfer, and remediation of methods for in-process, release, and stability testing.Knowledge of the major Pharmacopeia and ICH/FDA guidance documents.Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations.Ability to multitask managing deliverables on complex projects against timelines.Strong leadership, problem-solving, decision-making, and communication skills.Excellent technical writing skills and attention to detail in authoring methods, specifications, and regulatory filing documents.What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. is posted. Actual salary will vary based on several factors including relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans, work/life balance, and career development opportunities including:Comprehensive employee benefits package.A discretionary annual bonus program.Stock-based long-term incentives.Award-winning time-off plans.Flexible work models.Apply now
for a career that defies imagination.Amgen does not have an application deadline for this position.Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.Salary Range:
136,662.00 USD - 164,812.00 USD
#J-18808-Ljbffr