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

$113.1k - $145k

Altos Labs

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. 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. Location: Redwood City, CA. This is a full‑time onsite role (five days per week) with ad‑hoc flexibility. Salary ranges for Redwood City, CA: Scientist I, Drug Product : $113,100 - $145,000 Scientist II, Drug Product : $136,000 - $174,400 Senior Research Associate : $109,200 - $140,000 Research Specialist : $129,500 - $166,000 Exact compensation may vary based on skills, experience, and location. Equal Opportunity Employment Altos Labs provides equal employment opportunities to all employees and applicants for employment, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Altos prohibits unlawful discrimination and harassment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. #J-18808-Ljbffr Altos Labs

Vacancy posted 1 day ago
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