Senior Manager, Quality Control

Novo Nordisk • Boulder, CO

1d • Onsite

About The Position

Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory supporting phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operation of the Quality Control Chemistry laboratory supporting analysis of raw materials, in-process, final product samples, as well as routine stability samples for Novo Nordisk's phase 1 and 2 oligonucleotide API pilot facility located in Boulder Colorado. This role is a people manager and may manage up to 5 QC analysts, locally. This position requires a candidate with a robust background in analytical chemistry or a related field, coupled with significant experience in GMP laboratory settings and leadership roles. The ideal candidate will demonstrate proficiency in various laboratory techniques, regulatory knowledge, and strong communication skills, ensuring efficient and compliant laboratory operations.

Requirements

• Bachelor's Degree in chemistry, biological sciences, or related field of study with 7+ years of QC lab experience required
• 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

Nice To Haves

• Minimum two or more (2+) years of leadership/management experience in a bio-tech /pharmaceutical chemistry laboratory preferred

Responsibilities

• Requires full-time, on-site presence in support of manufacturing operations
• 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
• Other responsibilities, as assigned

Benefits

• Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position's level or other company factors.
• Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees