BioSpace
Process Development Senior Scientist
BioSpace, Thousand Oaks, California, United States, 91362
Join Amgen's mission of serving patients
At Amgen, if you feel like you are 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 have helped pioneer the world of biotech in our fight against the world's toughest diseases. With a focus on 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 lie 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 We are seeking a Senior Scientist to join our Commercial Attribute Sciences group in Thousand Oaks, California. The successful candidate will support Amgen's marketed biologic products, providing analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management activities. The role involves close partnership with local and global Quality and representation on global cross‑functional product teams, including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. You will translate product‑advancement business strategies into actionable scientific objectives and plans, engaging with executive leadership on key developments. Development opportunities to advance your career will be provided in partnership with your manager.
Key Responsibilities Include
Lead analytical method lifecycle management activities including method remediation, improvements, and support for method validation and transfers.
Contribute to global regulatory filings by authoring analytical CMC sections and RTQs, ensuring success of commercial approval and launch.
Independent authorship and review of technical reports, variations, and responses to analytical questions from health authorities.
Provide analytical method subject‑matter expert leadership for product quality and method‑related investigations, including OOS/OOT and unexpected result root‑cause determinations.
Interface and collaborate with other functional areas in a matrix environment, including teams across various geographic locations and time zones.
Establish timelines, achievements, methodological approaches, expected results, necessary resources, and communication to global cross‑functional team members.
Prepare clear written and verbal communications to key customers and senior leadership.
Implement innovative and fit‑for‑purpose analytical methods for release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities.
Keep current in the analytical development field, including literature and technology development for cutting‑edge and regulatory driven activities.
Provide analytical leadership for post‑approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop de‑risk strategies, and provide oversight to analytical results for regulatory submissions.
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 an individual with the following qualifications.
Basic Qualifications
Doctorate degree (PhD or PharmD) and relevant post‑doc where applicable, OR
Masters degree and 3 years of relevant experience, OR
Bachelors degree and 5 years of relevant experience.
Preferred Qualifications
Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering.
3+ years pharmaceutical/biotech experience in process development and analytical method development.
Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.
Commanding knowledge of analytical methods/technologies such as chromatography, CE, general assays (e.g. pH, osmolality, Karl Fisher titration), gels, bioassays, and immunoassays used to test diverse modalities.
Analytical project leadership experience.
Strong leadership skills and ability to independently lead.
Solid understanding of GMP requirements and familiarity with USP monographs and chapters, and ICH guidance documents related to analytical method transfer and validation.
Experience with developing, implementing and commercializing methods for in‑process testing, process characterization, release and stability testing.
Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
Experience with drug substance and drug product manufacturing processes.
Experience with regulatory filings and commercial quality systems.
Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control.
Experience with QbD and PAT, as applied to pharmaceutical development.
Experience managing and transferring commercial production and test methods.
Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams.
A diplomatic approach trusting and respectful interaction with global colleagues from a broad diversity of backgrounds, emphasis on listening.
Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents.
A self‑starter and teammate with strong decision‑making skills.
Ability to multitask, clearly plan and effectively follow through on complex deliverables.
What You Can Expect From Us As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we 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.
Total Rewards Plan
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.
Application Deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Equal Opportunity Employer 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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
#J-18808-Ljbffr
At Amgen, if you feel like you are 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 have helped pioneer the world of biotech in our fight against the world's toughest diseases. With a focus on 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 lie 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 We are seeking a Senior Scientist to join our Commercial Attribute Sciences group in Thousand Oaks, California. The successful candidate will support Amgen's marketed biologic products, providing analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management activities. The role involves close partnership with local and global Quality and representation on global cross‑functional product teams, including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. You will translate product‑advancement business strategies into actionable scientific objectives and plans, engaging with executive leadership on key developments. Development opportunities to advance your career will be provided in partnership with your manager.
Key Responsibilities Include
Lead analytical method lifecycle management activities including method remediation, improvements, and support for method validation and transfers.
Contribute to global regulatory filings by authoring analytical CMC sections and RTQs, ensuring success of commercial approval and launch.
Independent authorship and review of technical reports, variations, and responses to analytical questions from health authorities.
Provide analytical method subject‑matter expert leadership for product quality and method‑related investigations, including OOS/OOT and unexpected result root‑cause determinations.
Interface and collaborate with other functional areas in a matrix environment, including teams across various geographic locations and time zones.
Establish timelines, achievements, methodological approaches, expected results, necessary resources, and communication to global cross‑functional team members.
Prepare clear written and verbal communications to key customers and senior leadership.
Implement innovative and fit‑for‑purpose analytical methods for release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities.
Keep current in the analytical development field, including literature and technology development for cutting‑edge and regulatory driven activities.
Provide analytical leadership for post‑approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop de‑risk strategies, and provide oversight to analytical results for regulatory submissions.
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 an individual with the following qualifications.
Basic Qualifications
Doctorate degree (PhD or PharmD) and relevant post‑doc where applicable, OR
Masters degree and 3 years of relevant experience, OR
Bachelors degree and 5 years of relevant experience.
Preferred Qualifications
Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering.
3+ years pharmaceutical/biotech experience in process development and analytical method development.
Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.
Commanding knowledge of analytical methods/technologies such as chromatography, CE, general assays (e.g. pH, osmolality, Karl Fisher titration), gels, bioassays, and immunoassays used to test diverse modalities.
Analytical project leadership experience.
Strong leadership skills and ability to independently lead.
Solid understanding of GMP requirements and familiarity with USP monographs and chapters, and ICH guidance documents related to analytical method transfer and validation.
Experience with developing, implementing and commercializing methods for in‑process testing, process characterization, release and stability testing.
Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
Experience with drug substance and drug product manufacturing processes.
Experience with regulatory filings and commercial quality systems.
Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control.
Experience with QbD and PAT, as applied to pharmaceutical development.
Experience managing and transferring commercial production and test methods.
Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams.
A diplomatic approach trusting and respectful interaction with global colleagues from a broad diversity of backgrounds, emphasis on listening.
Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents.
A self‑starter and teammate with strong decision‑making skills.
Ability to multitask, clearly plan and effectively follow through on complex deliverables.
What You Can Expect From Us As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we 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.
Total Rewards Plan
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.
Application Deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Equal Opportunity Employer 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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
#J-18808-Ljbffr