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Senior Director Manufacturing
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Hengrui Pharma
Princeton, NJ (In Person)
Full-Time
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Job Description
Senior Director Manufacturing at Hengrui Pharma Senior Director Manufacturing at Hengrui Pharma in Princeton, New Jersey Posted in 5 days ago.
Develop production plans to ensure on-time, quality-compliant, and quantity-accurate delivery of peptide, oligonucleotide, and small molecule APIs; control costs and material losses. 2.Quality Compliance?
Strictly implement cGMP requirements; lead deviation, change control, and CAPA management; support regulatory and customer audits. 3.EHS & Equipment?
Primarily focus on new workshop construction and handover; implement safety and environmental responsibilities; manage key equipment such as synthesis, purification, and lyophilization systems to ensure compliant operation. 4.Team Building?
Build a technical production team; establish KPIs; enhance staff skills and efficiency. 5.Continuous Improvement?
Drive process optimization and lean manufacturing; improve yield and OEE. Qualifications 1.Master's degree or above in Pharmacy, Chemistry, Pharmaceutical Engineering, or a related discipline. 2.5+ years of API production experience, including at least 3 years in a Production Manager / Production Director role. Experience in new workshop construction and handover is required. 3.Familiar with cGMP; experience leading and passing official regulatory inspections. 4.Mastery of at least two types of processes among peptides, oligonucleotides, and small molecules. 5.Strong leadership, compliance awareness, and cross-functional coordination skills. 6.
Type:
full-timeJob Description:
Key Responsibilities 1.Production Management?Develop production plans to ensure on-time, quality-compliant, and quantity-accurate delivery of peptide, oligonucleotide, and small molecule APIs; control costs and material losses. 2.Quality Compliance?
Strictly implement cGMP requirements; lead deviation, change control, and CAPA management; support regulatory and customer audits. 3.EHS & Equipment?
Primarily focus on new workshop construction and handover; implement safety and environmental responsibilities; manage key equipment such as synthesis, purification, and lyophilization systems to ensure compliant operation. 4.Team Building?
Build a technical production team; establish KPIs; enhance staff skills and efficiency. 5.Continuous Improvement?
Drive process optimization and lean manufacturing; improve yield and OEE. Qualifications 1.Master's degree or above in Pharmacy, Chemistry, Pharmaceutical Engineering, or a related discipline. 2.5+ years of API production experience, including at least 3 years in a Production Manager / Production Director role. Experience in new workshop construction and handover is required. 3.Familiar with cGMP; experience leading and passing official regulatory inspections. 4.Mastery of at least two types of processes among peptides, oligonucleotides, and small molecules. 5.Strong leadership, compliance awareness, and cross-functional coordination skills. 6.