Amgen · 1 month ago
Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology
US - California - Thousand Oaks
Full-time
Hybrid
Mid, Senior Level
$128K/yr - $153K/yr
3+ years expAmgen is a biotechnology company dedicated to serving patients living with serious illnesses. In this role, the Process Development Senior Scientist will be responsible for the development and commercialization of biologics drug substance manufacturing processes, collaborating with cross-functional teams to ensure efficient and compliant operations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
Drive innovation and apply out-of-the-box thinking to contribute to technology development
Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group
Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner
Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment
Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing
Qualification
Required
Doctorate degree (Complete degree by 12/2025) OR
Master's degree and 3 years of life sciences experience OR
Bachelor's degree and 5 years of life sciences experience OR
Preferred
Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment
Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
Experience in filtration operations, including ultrafiltration/diafiltration
Understanding of protein characteristics and critical attributes to direct product/process control strategies
Proven ability to independently identify, develop and implement scientific solutions to practical problems
Motivated self-starter with excellent interpersonal and organizational skills
Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists
Eminence in the scientific community through a sustained record of peer reviewed publications
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
Familiarity with design of experiments and statistical analysis of data
Knowledge of license applications and the drug development process
Exposure to cGMP manufacturing and CMC components of regulatory submissions
Benefits
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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-08
FierceBiotech
2026-01-08
pharmaphorum
2026-01-08
Company data provided by crunchbase