Process Development Sr Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Sr Scientist to lead analytical science efforts in Attribute Sciences, guiding development of robust analytical methods and ensuring GMP/GLP compliance.

You will supervise analytical teams, drive ATP definitions, oversee method transfer, and collaborate with Drug Substance and Drug Product teams to support regulatory filings and product characterization.

Qualifications

• Doctorate or equivalent life science education and experience.
• Extensive experience with analytical method development and regulatory filings.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Supervise analytical support for late-stage product development.
• Lead an Attribute Sciences program and oversee analytical work for the program.
• Define ATP for methods, oversee method development, qualification, remediation, and transfer to QC.
• Coordinate activities at contract manufacturing/testing sites.
• Prepare technical reports and CMC sections for regulatory filings.

Skills

Analytical Chemistry

Regulatory filings

Cross-functional leadership

Biochemistry

Education

Doctorate degree

Masters degree with 2 years related life science experience

Bachelors degree with 4 years related life science experience

Associates degree with 8 years related life science experience

High school diploma / GED with 10 years related life science experience

Tools

HPLC

CE-SDS

cIEF

Size-exclusion HPLC

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets change the world. In this vital role you will join Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers, and live oncolytic viruses. Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

• Supervise and provide technical support for a team that provides analytical support for late stage product development
• Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
• Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
• Manage activities at 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 Amgens 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

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is an individual with these qualifications.

Basic Qualifications

• Doctorate degree
• OR
• Masters degree and 2 years of directly related life science experience
• OR
• Bachelors degree and 4 years of directly related life science experience
• OR
• Associates degree and 8 years of directly related life science experience
• OR
• High school diploma / GED and 10 years of directly related life science experience

Preferred Qualifications

• Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent.
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
• Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.
• Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
• Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
• Strong problem solving and effective multi-functional interpersonal skills.
• Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (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, managing deliverables against timelines
• Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
• Experience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
• A self-starter and team player with strong leadership and decision-making skill

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, well 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.

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 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.

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.