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Senior Manager, Quality Control
Novo Nordisk
Boulder, CO
Category
Quality Assurance
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Job Description
Senior Manager, Quality Control position responsible for overseeing the establishment and operation of a Quality Control laboratory supporting phase 1 and 2 oligonucleotide drug substance manufacturing. The role requires a robust background in analytical chemistry, experience in GMP laboratory settings, and leadership skills.
Requirements
Bachelor's Degree in chemistry, biological sciences, or related field of study
7+ years of QC lab experience
Minimum two or more (2+) years of leadership/management experience in a bio-tech/pharmaceutical chemistry laboratory
Knowledge of Chemical analysis, GMPs, laboratory techniques: HPLC/ UPLC/ UV-VIS/ Karl Fischer/ TOC/ pH/ Conductivity/ Endotoxin/ GC-HS / FTIR
Demonstrated knowledge of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP's within Quality Control laboratory
Excellent written & oral communication skills & the ability to author scientific & technical reports
Benefits
Medical, dental and vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy
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