Senior Associate Scientist

United Pharma; California; On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma in California seeks a process development scientist who will plan and execute formulation and process development studies, applying core engineering and science skills. The role emphasizes UF/DF, lyophilization, and robust analytical testing.

You will document results, perform data analysis with JMP/SAS, and contribute to technology transfers while maintaining rigorous records and compliance with GMP practices.

Qualifications

• Masters degree and 2 years of experience OR
• Bachelor's degree and 4 years of experience
• Experience in U/HPLC of various method types, UF/DF setup and operations, Lyophilization
• Familiarity with pharmaceutical/biotechnology process development
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing) and analytical techniques (SEC, CEX, HIAC, MFI)
• Understanding of protein stability and ADC familiarity preferred
• Proficiency in at least one statistical software package (SAS, JMP or Minitab)
• Excellent communication and organizational skills

Responsibilities

• Participate in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge
• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)
• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)
• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
• Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
• Author/review technical protocols and reports
• Participate in team meetings by sharing study designs, results and technical challenges

Skills

UHPLC

UF/DF

Lyophilization

Analytical methods

Data analysis

SAS/JMP/Minitab

Education

Masters degree

Bachelors degree

Tools

HPLC systems

Job description

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field
• 1+ years of experience in pharmaceuticals/biotechnology that includes process characterization, formulation development, equipment design and implementation, technology transfers
• Familiarity with pharmaceutical/biotechnology process development
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
• Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality. Familiarity with ADCs is preferred.
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
• Self-motivation, adaptability and a positive attitude
• Critical thinking, problem solving and independent research skills
• Good organizational skills with strong attention to detail
• Excellent communication (oral and written)

Basic Qualifications:

• Masters degree and 2 years of experience OR
• Bachelors degree and 4 years of experience

Must Have Skill Sets:

• Experience in U/HPLC of various method types, UF/DF setup and operations, Lyophilization

Day to Day Responsibilities:

• Participate in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge
• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)
• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)
• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
• Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
• Author/review technical protocols and reports
• Participate in team meetings by sharing study designs, results and technical challenges