Process Development Sr Scientist
$126.07k - $170.56kAmgen Foundation, Inc.
- # Process Development Sr ScientistApply: On Site: US - California - Thousand Oaks: Full time: Posted Today: R-255420## **Career Category**Scientific## ## **Job Description**## Join Amgen’s Mission of Serving PatientsAt 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Sr Scientist**## **What you will do**Let’s do this. Let’s change the world. In this vital role you will join the pivotal synthetic Attribute Sciences team, part of the integrated Pharmaceutical Attribute Sciences (iPAS) department, located in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.The analytical scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs across small molecules, synthetic peptides, siRNA, and synthetic components of conjugates. The analytical scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.**Key Responsibilities:*** Define analytical control strategies and implement methodologies to support the development of late-phase clinical programs, with a strong ability to articulate the challenges and complexities associated with analytical control strategy development.* Develop, optimize, authorize and validate analytical methods for attribute understanding and characterization across synthetic modalities, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates.* Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.* Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.* May lead activities and method transfer to contract manufacturing organization (CMO) or contract testing lab (CTL). Review and approve protocols, reports from CMO and CTL.* Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.* May lead and mentor a small group of scientists.## ## **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 these qualifications.**Basic Qualifications:*** Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR* Master’s degree and 3 years of Scientist experience OR* Bachelor’s degree and 5 years of Scientist experience**Preferred Qualifications:*** PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.* 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.* Experience in conjugates method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.* Strong understanding of synthetic molecule analysis and structure elucidation informed by knowledge of organic chemistry.* Hands on experience in method development, validation, and transfer for in-process, release, and stability testing* Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.* Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.* Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner* Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.* Excellent communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile* Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.* Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, 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 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.## Apply now and make a lasting impact with the Amgen team.## **careers.amgen.com**In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.## Application deadlineAmgen 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.## ## SponsorshipSponsorship 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.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..**Salary Range**126,066.05USD -170,559.95 USD
- J-18808-Ljbffr
Vacancy posted 10 hours ago
Similar jobs that could be interesting for youBased on the Process Development Sr Scientist in Thousand Oaks, CA vacancy
$157.74k - $213.41k
Process Development Senior Principal Scientist### Process Development Senior Principal ScientistApply: Flex Commuter / Hybrid: US - California - Thousand Oaks... ...supply of commercial drug products. We are seeking an Sr. Principal Scientist to lead commercial drug product programs...SeniorFull timeTemporary workFlexible hours- ...you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Sr Scientist What You Will Do Let’s do this. Let’s change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies...SeniorFlexible hours
- ...youll 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 Lets do this. Lets change the world. In this vital role you will join Amgens Pivotal Drug Product Technologies...SeniorFlexible hours
$157.74k - $213.41k
...ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Process Development Senior Principal Scientist What you will doLet’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug...SeniorFull timeFlexible hoursAmgen
Thousand Oaks, CA4 days ago- US Tech Solutions is seeking a biologics formulation and process development specialist to support drug product development in collaboration with a team of engineers and scientists. The role focuses on planning, execution, and documentation of studies to enable commercialization...SuggestedContract work
- ...you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will perform sample preparation,...Flexible hours
$90.44k - $122.36k
...transform the lives of patients while transforming your career.Process Development Associate Scientist - Drug Product Visual Inspection SciencesWhat you will... ...Product Technologies organization. Reporting to the Sr Principal Scientist Visual Inspections Manager of Amgen...Full timeFlexible hoursAmgen
Thousand Oaks, CA2 days ago- Amgen in Thousand Oaks, CA, seeks a Principal Scientist Bioconjugation to lead development of manufacturing processes for bioconjugates, including antibody drug conjugates (ADCs), and to drive technology innovation within the DSTS group of Process Development. You will...
$38 - $43 per hour
Akraya, Inc. in Thousand Oaks, CA is seeking a role to support senior scientists in developing and validating drug product manufacturing processes. You will execute experiments, analyze data and contribute to documentation for technology transfers, with strong organizational...Hourly payContract work$38 - $43 per hour
...#LP Job Summary: This role supports senior scientists in developing and validating drug product manufacturing processes. You will be responsible for executing... ...industry is preferred, with a focus on drug product development or manufacturing processes. ABOUT AKRAYA...Hourly payContract workAkraya, Inc.
Thousand Oaks, CA16 days ago- Amgen in Thousand Oaks (CA) or Cambridge (MA) seeks a Principal Scientist in Oligonucleotides to lead development of sustainable manufacturing processes, drive capacity expansion, and oversee technology transfers to GMP facilities. The role requires extensive experience...
$28.85 per hour
...Job Description Job Description Aptask Global Workforce (AGW) is seeking a Process Development Associate Scientist for a contract position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity. This role is within...Hourly payContract work- US Tech Solutions in Thousand Oaks, CA is seeking a Process Development Senior Associate to join the Pivotal Drug Product Technologies Group. This role supports late-stage drug product formulation and fill/finish process development for large molecule modalities and collaborates...Senior
- Planet Pharma in Thousand Oaks is seeking a Process Development Associate to join the Process Microbiology Group. You will execute studies in microbiology method development, optimization, and troubleshooting within a collaborative team environment. Responsibilities include...Senior
- Amgen is seeking a Process Development Senior Scientist to join our Biologics Drug Product Technologies group in Thousand Oaks. You will lead early-stage formulation development, focusing on monoclonal antibodies and other biologics, and drive scalable fill/finish processes...Senior
$72.8k - $97.1k
...water quality environmental monitoring electronics design and development oceanographic research deepwater oil and gas exploration and production... ...Teledyne Scientific & Imaging as a CSAC Manufacturing and Process Engineer! Are you ready to launch your career to the next...Minimum wageFull timeWork experience placementLocal areaTeledyne Technologies
Thousand Oaks, CA4 days ago- ...individual with a background in microbiology for the position of Process Development Associate within the Process Microbiology Group. The... ...The PD Associate will work collaboratively with a team of scientists to execute studies supporting microbiological method development...Senior
- ...the lives of patients while transforming your career.Sr Associate IS Analyst - Process Development LabsWhat you will doLet’s do this. Let’s change the world... ...a reliable, secure technology environment for the scientists advancing our medicines. Based at Amgen’s Thousand...SeniorFull timeFlexible hours
Amgen
Thousand Oaks, CA2 days ago $134.17k - $181.52k
...transform the lives of patients while transforming your career.Sr.Data Scientist - Process ModelingWhat you will doLet’s do this. Let’s change the... ...Process and Systems Analysis group within Process Development plays a key role in providing data infrastructure, platforms...SeniorFull timeWork experience placementFlexible hoursAmgen
Thousand Oaks, CA3 days ago$165.5k - $223.91k
...patients while transforming your career. Sr. Principal Scientist - Immunogenicity Bioanalytical... ...vital role you will support the design, development, validation, and implementation of assays... ...in the job application or interview process, to perform essential job functions,...SeniorFlexible hours$43 - $50.48 per hour
...part of something extraordinary. Apply now and help us build the future of defense and space. POSITION PROFILE: The Semiconductor Process Technician is experienced in semiconductor fabrication and expereince in a Focal Plane Array manufacturing environment is a plus....Hourly payPermanent employmentFull timeTemporary workNight shiftSafran Defense & Space Inc
Camarillo, CA3 days ago- Safran DSI in the Ventura/Oxnard area is seeking a Semiconductor Process Technician with hands-on fabrication experience to support our defense and space programs. You will perform photolithography, etching, thin films and metals deposition, handle delicate optoelectronic...
- Amgen Inc. is seeking a Process Development Senior Principal Scientist to lead commercial drug product programs, driving formulation design, aseptic processing, and lifecycle management of parenteral products. The role partners with Drug Product Technologies to advance...Senior
$85k - $105k
...employer to ask for an accommodation or an alternative application process. Easton R&D - Bats Salary Full Time Professional Thousand... ...policies and procedures, the role is responsible for development, design, and testing of Rawlings/Easton bat products. Duties...Full timeCasual workWork at officeRawlings Sporting Goods
Thousand Oaks, CA1 day ago$162k - $239.76k
...of RF Analog & Sipho Test Engineers. The Sr Principal Test engineer is responsible for independently leading test and development for Marvell analog & Sipho products.What You... ...highly robust and automated test processes to guarantee product qualityWork with Design...SeniorPermanent employmentFull timeInternshipWork from homeMarvell
Westlake Village, CA1 day ago- Firstsource is a specialized global business process management partner. We provide transformational solutions and services spanning the customer lifecycle across Healthcare, Banking and Financial Services, Communications, Media and Technology, and other diverse industries...Senior
- ...including ALL in-life components) Team support for multiple ongoing studies/study activities Study data acquisition, organization, analysis, quality control Graphing and PP deck preparation for presentation Study/data documentation Study sample processing/inventory/trackingSenior
Planet Pharma
Thousand Oaks, CA2 days ago - ...change controls to ensure facilities, systems, equipment, and processes comply with regulatory requirements, company standards, and current... ...documentation Provide validation expertise during the development or modification of manufacturing facilities, utilities, equipment...SeniorFull timeFor contractors
VTI Life Sciences
Thousand Oaks, CA21 days ago - Amgen in Thousand Oaks, CA, seeks a Principal Scientist to lead bioconjugation process development and industrialization of ADC manufacturing. The role drives technology innovation, mentors staff, and ensures cGMP transfer to CMOs while advancing Amgen's portfolio. You...
- ...Associate - Protein Chemistry (Analytics)Seeking a highly motivated Sr. Associate to join the Protein Therapeutics (PT) - Protein... ...selection of large molecule drug candidates that advance to Process Development.In this role, you will support the analysis and...Senior
Planet Pharma
Thousand Oaks, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Process Development Sr Scientist. Be the first to apply!
Related searches
- process development scientist Thousand Oaks, CA
- r&d engineering technician Thousand Oaks, CA
- product development scientist Thousand Oaks, CA
- research and development engineer Thousand Oaks, CA
- r&d engineer Thousand Oaks, CA
- product development engineer Thousand Oaks, CA
- development engineer Thousand Oaks, CA
- international tax senior Thousand Oaks, CA
- senior sales Thousand Oaks, CA
- senior network engineer remote Thousand Oaks, CA