Amgen SA
Process Development Senior Scientist
Amgen SA, Thousand Oaks, California, United States, 91362
Join Amgen’s Mission of Serving Patients
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 Senior Scientist What you will do Let’s do this! Let’s change the world!
Amgen is seeking a Process Development Scientist within our Pre‑pivotal Bioprocess Development (BD) organization based at our Thousand Oaks, California campus. Pre‑pivotal BD is responsible for the development, scale‑up, and transfer of both upstream and downstream processes for early clinical manufacturing of therapeutic molecules. The programs develop a wide range of biological molecules including mAbs, BiTEs, bispecifics, conjugations, and other novel modalities ranging from early molecule assessments with Research to IND enabling GMP manufacturing supplies for clinical studies.
The primary focus of this position will be downstream purification development. The drug substance development deliverables for this role include molecule assessments, clone selections, First‑In‑Human (FIH) purification process development, and tech transfers to clinical manufacturing. In addition, the role will entail the development and implementation of new purification technologies, authoring regulatory CMC documents, and evaluating process capabilities for viral clearance.
Key Responsibilities
Leading a team of purification scientists to develop processes for clinical manufacturing
Applying technical and platform knowledge to design studies for the development of purification processes
Serving in cross‑functional or cross‑site roles
Contributing to the scientific literature and conferences, gaining recognition as a subject‑matter expert in both internal and external purification communities
Investigating and implementing relevant new technologies
Interfacing with regulatory agencies in support of CMC filings
Analyzing and presenting data internally for governance and technical meetings
Contributing to viral clearance process evaluations and company strategies
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a Scientist with these qualifications.
Basic Qualifications
Bachelor’s degree and 5 years of scientific experience
Master’s degree and 3 years of scientific experience
Doctorate degree (PhD, PharmD, MD) or relevant post‑doc where applicable
Preferred Qualifications
Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline
Experience contributing to and/or participating in purification science
Expertise and experience in purification process development
Extensive experience in development and/or support of biomanufacturing processes, including process scale‑up and GMP production
Track record of innovation and implementation of new technologies
Experience in authoring IND sections and interaction with regulatory agencies
Experience in viral clearance evaluation per ICH Q5A guidelines
Understands purification techniques for biological molecules (e.g. chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation, etc.)
Independently authors technical reports, regulatory filings, patents, and peer‑reviewed publications
Capable of conveying information and recommendations on scientific issues to senior management
Serves as a technical authority and keeps current in relevant literature and related technology
Works cross‑functionally to author CMC documents in support of Amgen’s regulatory filings
Develops processes to deliver multi‑kilogram quantities of drug substance to cGMP operation
Leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity
Ensures that safe laboratory practices are followed
Provides mentoring and expertise to less‑experienced staff
What you can expect from 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.
Compensation and Benefits 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
Apply Now Make a lasting impact with the Amgen team.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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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 Senior Scientist What you will do Let’s do this! Let’s change the world!
Amgen is seeking a Process Development Scientist within our Pre‑pivotal Bioprocess Development (BD) organization based at our Thousand Oaks, California campus. Pre‑pivotal BD is responsible for the development, scale‑up, and transfer of both upstream and downstream processes for early clinical manufacturing of therapeutic molecules. The programs develop a wide range of biological molecules including mAbs, BiTEs, bispecifics, conjugations, and other novel modalities ranging from early molecule assessments with Research to IND enabling GMP manufacturing supplies for clinical studies.
The primary focus of this position will be downstream purification development. The drug substance development deliverables for this role include molecule assessments, clone selections, First‑In‑Human (FIH) purification process development, and tech transfers to clinical manufacturing. In addition, the role will entail the development and implementation of new purification technologies, authoring regulatory CMC documents, and evaluating process capabilities for viral clearance.
Key Responsibilities
Leading a team of purification scientists to develop processes for clinical manufacturing
Applying technical and platform knowledge to design studies for the development of purification processes
Serving in cross‑functional or cross‑site roles
Contributing to the scientific literature and conferences, gaining recognition as a subject‑matter expert in both internal and external purification communities
Investigating and implementing relevant new technologies
Interfacing with regulatory agencies in support of CMC filings
Analyzing and presenting data internally for governance and technical meetings
Contributing to viral clearance process evaluations and company strategies
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a Scientist with these qualifications.
Basic Qualifications
Bachelor’s degree and 5 years of scientific experience
Master’s degree and 3 years of scientific experience
Doctorate degree (PhD, PharmD, MD) or relevant post‑doc where applicable
Preferred Qualifications
Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline
Experience contributing to and/or participating in purification science
Expertise and experience in purification process development
Extensive experience in development and/or support of biomanufacturing processes, including process scale‑up and GMP production
Track record of innovation and implementation of new technologies
Experience in authoring IND sections and interaction with regulatory agencies
Experience in viral clearance evaluation per ICH Q5A guidelines
Understands purification techniques for biological molecules (e.g. chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation, etc.)
Independently authors technical reports, regulatory filings, patents, and peer‑reviewed publications
Capable of conveying information and recommendations on scientific issues to senior management
Serves as a technical authority and keeps current in relevant literature and related technology
Works cross‑functionally to author CMC documents in support of Amgen’s regulatory filings
Develops processes to deliver multi‑kilogram quantities of drug substance to cGMP operation
Leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity
Ensures that safe laboratory practices are followed
Provides mentoring and expertise to less‑experienced staff
What you can expect from 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.
Compensation and Benefits 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
Apply Now Make a lasting impact with the Amgen team.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#J-18808-Ljbffr