Senior Manager, Quality Control
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Boulder • Colorado • 🇺🇸 United States
Visit company websiteSalary
💰 $116,810 - $216,100 per year
Job Level
Senior
About the role
- Oversee the establishment of a GMP QC Laboratory including equipment qualification and resource planning specific to the analytical QC laboratory
- Assist with implementation and integration LIMS and other Novo software systems as they relate to Quality Control
- Create and refine process and procedures for QC related testing such as, but not limited to: Appearance, HPLC, UPLC and GC analysis, Karl Fischer, UV, pH, Conductivity, TOC, endotoxin, and FTIR
- Work closely with Analytical Development on method validation protocols and execution relevant to product methods
- Routine analysis of raw materials, in-process, release, and stability samples to support phase 1 and 2 drug substance manufacturing
- Collaborate with Analytical Development to resolve method and instrument performance issues as needed
- Coordinate with the Associate Director of QC and other teams to address workload issues and prioritize tasks effectively
- Ensure effective communication and knowledge transfer with internal customers, aligning with all relevant stakeholders
- Support the training and development of personnel
Requirements
- Bachelor's Degree in chemistry, biological sciences, or related field of study with 7+ years of QC lab experience required
- Minimum two or more (2+) years of leadership/management experience in a bio-tech /pharmaceutical chemistry laboratory preferred
- Knowledgeable in the following: Chemical analysis, GMPs, laboratory techniques: HPLC/ UPLC/ UV-VIS/ Karl Fischer/ TOC/ pH/ Conductivity/ Endotoxin/ GC-HS / FTIR
- Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications
- Demonstrated knowledge of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP’s within Quality Control laboratory
- Demonstrated knowledge of pharmaceutical industry validation requirements as it relates to GMP Quality Control laboratory
- Excellent written & oral communication skills & the ability to author scientific & technical reports preferred
- Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs preferred
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
- Sick time policy
- Flexible vacation policy
- Parental leave policy
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
HPLCUPLCGCKarl FischerUVpHConductivityTOCendotoxinFTIR
Soft skills
attention to detailproofreadingstrong computer skillswillingness to learnexcellent written communicationexcellent oral communicationplanningorganizingproblem-solvingcollaboration