Summary

Manufacturing Upstream Specialist
Job Responsibilities

Participate in large-scale manufacturing operations through robust scale-up and implementation of new Upstream processes and equipment.

Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.

Participate in Upstream Process Characterization (PC) and Process Validation (PV) including study protocol drafting, experiment execution and report drafting.

Use scale-up experience and engineering principles to troubleshoot equipment and processes; anticipate potential problems and propose risk mitigations and solutions.

Develop / execute plans and /or experiments to investigate process related deviations in Upstream areas in a timely and conclusive manner and propose comprehensive process solutions and improvements

Author technical documentation to support deviations, experiments and other activities

Use knowledge of statistical data mining and techniques to perform data analysis and mining of complex data sets to support continued process verification (CPV) and ongoing GMP production.

Job Qualifications (Education, Certifications, Experience)

At least Bachelor’s Degree in Life Sciences or Chemical Engineering with five plus (5+) OR Master’s with three plus (3+) OR PhD with one plus (1+) years of industry experience.

Technical knowledge of Upstream process science, manufacturing principles and techniques.

Knowledge of process characterization and process validation.

Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).

Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet.

Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.

Communicate effectively and work professionally in a team environment.

Skilled in the use of computers and automation-drive equipment.