Process Development Sr Scientist - Thousand Oaks, CA
Process Development Sr Scientist - Thousand Oaks, CA
Posted on :
27-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
27-06-2025
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
What you will do
Lets do this! Lets change the world!
In this vital role Amgen is seeking a Process Development Senior Scientist for the Pre-Pivotal Drug Product Technologies group in Thousand Oaks CA. This role supports early-stage drug product development across diverse modalities including monoclonal antibodies bispecifics fusion proteins antibody-drug conjugates and oligonucleotides. The role involves designing and developing liquid frozen and lyophilized formulations; evaluating critical quality attributes (CQAs) relating to shelf-life stability and in-use stability; and establishing robust scalable fill/finish and drug product processes.
The ideal candidate will integrate formulation analytical and process data to guide product design apply cutting-edge technologies (including AI/ML) and collaborate cross-functionally to deliver high-quality stable and manufacturable drug products for clinical development.
Responsibilities will include:
Plan and execute formulation and fill/finish process studies for early-stage programs.
Develop and characterize formulations (liquid lyophilized frozen) and lab-scale sterile filling.
Build process understanding across unit operations to support scalable drug product strategies.
Evaluate in-use compatibility and drug product stability under clinical conditions.
Investigate CQAs (e.g. aggregation chemical modification surface interactions etc.) to inform formulation and process decisions.
Leverage high-throughput tools for formulation screening and processability assessments.
Identify and address gaps in technologies impacting protein stability and interactions.
Apply machine learning AI and data science to predictive modeling workflow acceleration and decision-making.
Ensure development approaches are phase-appropriate from discovery through clinical manufacturing.
Author technical documents risk assessments IND/CTA/BLA regulatory sections and tech transfer packages.
Support successful technology transfer to manufacturing (internal or external CMOs).
Present findings to internal/external stakeholders and participate in cross-functional teams.
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 Self-starter with these qualifications.
What you will do
Lets do this! Lets change the world!
In this vital role Amgen is seeking a Process Development Senior Scientist for the Pre-Pivotal Drug Product Technologies group in Thousand Oaks CA. This role supports early-stage drug product development across diverse modalities including monoclonal antibodies bispecifics fusion proteins antibody-drug conjugates and oligonucleotides. The role involves designing and developing liquid frozen and lyophilized formulations; evaluating critical quality attributes (CQAs) relating to shelf-life stability and in-use stability; and establishing robust scalable fill/finish and drug product processes.
The ideal candidate will integrate formulation analytical and process data to guide product design apply cutting-edge technologies (including AI/ML) and collaborate cross-functionally to deliver high-quality stable and manufacturable drug products for clinical development.
Responsibilities will include:
Plan and execute formulation and fill/finish process studies for early-stage programs.
Develop and characterize formulations (liquid lyophilized frozen) and lab-scale sterile filling.
Build process understanding across unit operations to support scalable drug product strategies.
Evaluate in-use compatibility and drug product stability under clinical conditions.
Investigate CQAs (e.g. aggregation chemical modification surface interactions etc.) to inform formulation and process decisions.
Leverage high-throughput tools for formulation screening and processability assessments.
Identify and address gaps in technologies impacting protein stability and interactions.
Apply machine learning AI and data science to predictive modeling workflow acceleration and decision-making.
Ensure development approaches are phase-appropriate from discovery through clinical manufacturing.
Author technical documents risk assessments IND/CTA/BLA regulatory sections and tech transfer packages.
Support successful technology transfer to manufacturing (internal or external CMOs).
Present findings to internal/external stakeholders and participate in cross-functional teams.
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 Self-starter with these qualifications.
Additional Qualifications/Responsibilities
Basic Qualifications:
Bachelors degree and 5 years of scientific experience OR
Masters degree and 3 years of scientific experience OR
Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable
Preferred Qualifications:
PhD in Pharmaceutics Biotechnology Biochemistry Physical Biochemistry or related field with 24 years of postdoctoral or industry experience.
Proven experience in formulation development stability testing and fill/finish operations for biologics.
Strong foundation in analytical and biophysical techniques (e.g. UPLC/HPLC SEC IEX RP-HPLC CE-SDS) applied to drug product development.
Familiarity with phase appropriate development manufacturability and risk-based decision-making.
Experience applying AI/ML (e.g. LLMs in silico tools) to streamline innovation processes and optimize performance.
Skilled communicator with experience presenting technical and strategic content across functional teams.
Demonstrated experience with contributing to regulatory submissions including authoring CTAs amendments and/or BLAs.
Required Experience:
Senior IC
Employment Type
Full Time
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