Senior Research Associate/ Scientist, Drug Product Process Development and Manufacturing

Altos Labs

$109K — $140K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Ph.D. in chemical engineering, biochemical engineering, biotechnology, pharmaceutical sciences, or related field with 2-3 years of industry experience, OR a Master's degree with 6 years of relevant experience.
  • Hands-on experience with mRNA-LNP formulation/process development strongly preferred.
  • Experience with protein therapeutics/AAV gene therapy formulation is a plus.
  • Knowledge of formulation development and process optimization.
  • Familiarity with drug product unit operations like filling, filtration, and mixing.
  • Understanding of stability of biologics and effects of process-related stresses on quality.
  • Excellent communication and problem-solving skills.

Responsibilities

  • Develop hands-on formulations and processes for mRNA-LNP therapeutics, AAV gene therapy, and protein drugs.
  • Design and execute experiments for drug product formulation stability and optimization.
  • Scale up drug product manufacturing processes considering CPPs and CQAs.
  • Conduct stability testing under various storage conditions to identify degradation.
  • Collaborate with CDMOs to optimize manufacturing processes and support scale-up operations.
  • Maintain accurate laboratory records and contribute to regulatory submissions.
  • Stay updated on industry trends and contribute to process improvement.

Benefits

  • Dynamic cross-functional working environment.
  • Support for professional growth and continuous improvement culture.
  • Involvement in innovative mRNA and gene therapy programs.
  • Opportunities for collaboration with external partners.
Full Job Description
What You Will Contribute To Altos

We are seeking a highly motivated and hands-on Scientist to join the Drug Product Process Development team within Technical Operations at the Institute of Medicine. This is a predominantly bench-based role; the successful candidate will independently design and execute experiments daily, advancing mRNA-LNP,AAV and Protein-based therapeutic programs. Working in a dynamic and cross-functional environment, this scientist will perform formulation and drug product process development, and provide technical support for outsourced GMP manufacturing activities.

Responsibilities
  • Perform hands-on formulation and drug product process development for mRNA-LNP therapeutics, with additional involvement in AAV gene therapy and protein drug product development.
  • Design and execute experiments to develop stable and effective drug product formulations, including excipient selection, concentration optimization, and compatibility studies; build internal drug product process development capabilities and produce materials to supply non-clinical studies.
  • Develop and scale up drug product manufacturing processes, considering critical process parameters (CPPs) and critical quality attributes (CQAs); apply statistical analysis and experimental design to optimize process parameters and maximize product yield and quality.
  • Conduct stability testing to assess the long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
  • Collaborate with CDMOs to optimize and improve drug product manufacturing processes, support scale-up, and contribute to in-process control strategies; provide technical support for GMP manufacturing activities including document review.
  • Maintain accurate laboratory records, document experimental protocols and results, and contribute to development reports and regulatory submissions.
  • Stay current with industry trends, emerging technologies, and regulatory guidelines to support continuous process improvement and compliance.
  • Actively contribute to a team culture of continuous improvement, ownership, professional growth, and inclusion.
Who You Are

Qualifications
  • Scientist Level Reqrurement: Ph.D. in chemical engineering, biochemical engineering, biotechnology, pharmaceutical sciences, or a related field with 2-3 years of relevant industry experience
  • Senior Research Associate Requirement: Master's degree in a related discipline with a minimum of 6 years of relevant industry experience in drug product process development
  • Hands-on experience with mRNA-LNP formulation and/or process development is strongly preferred.
  • Experience with protein therapeutics and/or AAV gene therapy formulation development is a plus.
  • Experience with formulation development, process optimization, and drug product development
  • Experience with drug product unit operations (e.g., filling, filtration, mixing), including scale-down model development, characterization, and scale-up.
  • Understanding of the physical and chemical stability of biologics and how process-related stresses impact product quality.
  • Strong problem-solving skills with the ability to independently design experiments, interpret complex data sets, and communicate findings clearly.
  • Ability to thrive in a dynamic, fast-paced environment, adapting readily to shifting priorities with a willingness to develop new technical skills and to work across multiple therapeutic modalities.
  • Excellent written and verbal communication skills; ability to collaborate effectively in a diverse, global, cross-functional organization and a commitment to diversity, equity, and belonging.
  • This is a full-time onsite role (five days per week) in Redwood City, CA, with ad-hoc flexibility.
  • Final job level will be determined based on the selected candidate's experience and qualifications.


The salary range for Redwood City, CA:
  • Scientist I, Drug Product: $113,100 - $145,000
  • Scientist II, Drug Product: $136,000 - $174,400

The salary range for Redwood City, CA:
  • Senior Research Associate: $109,200 - $140,000
  • Research Specialist: $129,500 - $166,000

Exact compensation may vary based on skills, experience, and location.

#LI-NN1

For UK applicants, before submitting your application:

- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (bit.ly/eu_uk_privacy_notice)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.

Similar Jobs

More Jobs at Altos Labs

More Pharmaceuticals & Biotech Jobs

Find similar Senior Research Associate/ Scientist, Drug Product Process Development and Manufacturing jobs: