Job Details
Job Title: Analyst, Analytical Development
Education Required:
Minimum of 2+ years working experience with a bachelor s or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.
General Description:
Perform analytical tests to support process development and transfer analytical methods to QC department.
Essential Functions of the job:
Write SOP, experimental methods, and reports. Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development.
Support the development and transfer of analytical methods of biologics drugs (including monoclonal antibodies, bispecific antibodies, ADC).
Understand CMC process of biologics drugs, and operation specification for QC and QA.
Understand the quality requirement of biologics drugs application, cooperate with the application to the complete the experiments or reports.
Support sample preparation, reagent management, stable sample management.
Core Competencies, Knowledge, and Skill Requirements
Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
Proficient in analytical chemistry or biology background, skilled in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) analysis methods, including but not limited to HPLC, UPLC, CE, Elisa.
Credible and confident communicator (written and verbal) at all levels.
Strong analytical and problem-solving ability.
Ability to prioritize, demonstrating good time management skills.
Self-motivated, with the ability to work proactively using own initiative.
Committed to learning and development.
Significant Contacts
Interacts with all levels of employees.
Supervisory Responsibilities:
N/A
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time.Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:N/A
Travel:
Must be willing to travel approximately 10%
Ability to work on a computer for extended periods of time