Job Summary:

The NJ Bio QC Team Lead is a hands-on laboratory position with additional supervisory and management responsibilities. The QC Team Lead will manage a group of QC scientists. The QC Team Lead will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), nucleic acids, and other pharmaceutical products in a GMP setting.

Job Responsibilities:

Manage and lead a group of junior scientists.

Schedule team work assignments based on project deadlines.

Perform detailed peer review of analytical data to ensure accuracy.

Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.

Work with management and vendors to acquire, install, and qualify new equipment.

Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.

Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.

Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.

Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.

Conduct OOS, risk assessment, and root cause investigations and/or assist senior management with these investigations.

Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.

Document work in laboratory notebooks and logbooks according to organizational GDP policies.

Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.

Manage work outsourced to third-party analytical and metrology service providers.

Required Knowledge, Skills and Abilities:

Experience in leading people and projects.

Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.

Education and Experience Requirements:

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• Experience in a GMP manufacturing or CRO setting.
• BS with at least 5 years of relevant experience, MS or higher degree with at least 4 years of relevant experience, or equivalent combination of work experience, education, and training

Physical Demands:

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds
• Frequently requires the use of a step stool
• Requires manual dexterity and visual abilities

Working Conditions:

Laboratory and office environment

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Experience level:

• 1 year
• 4 years

Schedule:

• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Princeton, NJ 08540: Relocate before starting work (Required)

Work Location: In person