Requirements
Third level Bachelor's degree in science, engineering or equivalent discipline with 5 years experience in a commercial manufacturing or NPI role OR Master's degree & 3 years of directly related experience OR Associate's degree & 7 years of directly related experience.
Knowledge of c GMPs and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications
Doctorate or Masters in Science or Engineering.
Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze‑thawing, filtration, mixing, filling (Pp K / batch homogeneity).
Knowledge of protein biochemistry with regard to chemical and physical stability.
Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
Demonstrated ability in providing leadership to cross‑functional teams to advance complex projects to completion.
Excellent Communication skills are essential for this role.
Shift Pattern
Required: 24/7 support once or twice a quarter for approx.
1-2 weeks at a time.
35% shift rate applies.
Confirmed shift pattern: 2 days on 7am-7pm, 2 nights 7pm-7am, 4 days (unspecified)
Seniority level
Not Applicable
Employment type
Contract
Job function
Pharmaceutical Manufacturing
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