Senior Manager Quality Control

Quality Control Manager/Sr. Manager

We are seeking an experienced Quality Control professional to support analytical testing activities for biologic drug development programs. This individual will serve as a key liaison between internal teams and external testing laboratories, ensuring high-quality analytical support for GMP testing, method validation, and product release activities.

This is an excellent opportunity for someone with strong biologics experience, particularly in monoclonal antibody programs, who enjoys working cross-functionally in a fast-paced, growing environment.

Key Responsibilities

+ Oversee day-to-day Quality Control testing activities conducted by contract manufacturing organizations (CMOs) and external testing laboratories.

+ Act as a primary technical contact for external laboratory partners and participate in operational and scientific discussions.

+ Support analytical method validation, qualification, and transfer activities.

+ Troubleshoot analytical methods, assay performance issues, testing delays, and laboratory-related challenges.

+ Manage sample logistics and tracking, including shipment coordination, testing status updates, and result timelines.

+ Monitor laboratory performance and ensure testing schedules and deliverables remain on track.

+ Coordinate testing priorities, sample requirements, and laboratory capacity planning.

+ Collaborate closely with Quality Assurance, Analytical Development, Manufacturing, and other cross-functional teams.

+ Support GMP testing activities and product release timelines.

+ Communicate technical findings, project risks, and testing updates to internal stakeholders.

+ Build strong relationships with external testing partners and effectively manage timelines, priorities, and expectations.

Qualifications

+ Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.

+ 8+ years of experience with significant Quality Control experience within the biotechnology, pharmaceutical, or biologics industry.

+ Hands-on experience supporting biologic drug development programs, including monoclonal antibodies.

+ Proven experience with analytical method validation and method transfer activities.

+ Strong understanding of GMP regulations and quality requirements related to analytical testing and product release.

+ Experience working directly with CMOs, contract testing organizations, or external laboratory partners.

+ Demonstrated ability to troubleshoot analytical methods and laboratory testing issues.

+ Experience managing sample tracking, testing timelines, laboratory communications, and data review activities.

+ Excellent communication, stakeholder management, and project coordination skills.

+ Ability to work independently and manage multiple priorities in a dynamic environment.

Preferred Experience

+ Previous experience supporting GMP Quality Control laboratories.

+ Experience working with biologics, protein therapeutics, or monoclonal antibody products.

+ Strong understanding of analytical testing strategies for clinical and commercial manufacturing programs.

Job Type & Location

This is a Contract position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $75.00 - $85.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Waltham, MA.

Final date to receive applications

This position is anticipated to close on Oct 26, 2026.

Workplace Type

This is a hybrid position in Waltham,MA.

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