Process Development Senior Associate

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)
• Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
• 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

Qualifications

• Masters degree
• OR
• Bachelors degree and 2 years of Scientific experience
• OR
• Associates degree and 4 years of Scientific experience
• OR
• High school diploma / GED and 6 years of Scientific experience

Preferred Qualifications

• 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
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
• 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)