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Job Title: Manager, Laboratory Operations - Biologics

Job Description

The Manager, Laboratory Operations - Biologics is responsible for providing strategic, technical, and operational leadership within the Bioseparations & Mass Spectrometry department. This role demands a balance of scientific expertise, business acumen, and customer focus to deliver high-quality services, ensure efficient execution, and promote sustained growth in a fast-paced environment. The ideal candidate will excel in biologics development and testing, thriving in a client-driven CDMO setting.

Responsibilities

+ Act as the primary contact for key biologics clients, ensuring exceptional customer service and responsiveness.

+ Oversee analytical services supporting biologics, including bioseparations, characterization, release, stability testing, and specialty studies.

+ Apply extensive experience with mass spectrometry to biologics, including method development, characterization, and data interpretation.

+ Translate client needs into actionable project plans, balancing scientific rigor with business requirements.

+ Serve as a subject matter expert in Biologics for internal and external stakeholders.

+ Ensure projects are executed on time, within budget, and to the highest quality standards.

+ Lead capacity planning, resource allocation, and prioritization of biologics projects across the analytical team.

+ Drive operational efficiency, technical advancements, and laboratory innovation.

+ Foster a culture of quality, compliance, scientific excellence, and continuous improvement.

+ Drive professional development, technical training, and succession planning for staff.

+ Attract, develop, and retain a high-performing team through effective selection, training, coaching, mentoring, and performance management.

+ Promote a collaborative and innovative environment that encourages problem-solving and accountability.

+ Ensure adherence to SOPs, training, and other regulatory requirements.

+ Stay current on industry and regulatory laboratory trends and adapt quality systems, practices, and procedures accordingly.

Essential Skills

+ Deep hands-on experience with mass spectrometry for biologics characterization.

+ Familiarity with biologic modalities such as monoclonal antibodies, peptides, oligonucleotides, and cell/gene therapies.

+ Strong command of HPLC techniques for purity, potency, and stability testing.

+ Experience with capillary electrophoresis for charge variant analysis and glycan profiling.

Additional Skills & Qualifications

+ Doctorate degree with 8+ years, or Master’s degree with 10+ years, or Bachelor’s degree with 12+ years in Chemistry, Biochemistry, or related field.

+ 2+ years of previous supervisory experience.

+ Experience in development, validation, and verification of analytical testing methods.

+ Experience with inspections/audits by regulatory agencies and clients.

+ Previous experience within CMO or CDMO preferred.

+ Experience in a pharmaceutical GMP environment required.

Work Environment

This role is part of a team where your expertise in mass spectrometry, bioseparations, and biologics is essential. As Manager, Laboratory Operations – Biologics, you will lead high-impact analytical programs supporting cutting-edge biologic modalities in a hands-on leadership role within a fast-paced CDMO environment. The new site expansion covers 20,000 square feet, providing a dynamic and innovative setting.

Job Type & Location

This is a Permanent position based out of Durham, North Carolina.

Pay and Benefits

The pay range for this position is $130000.00 - $165000.00/yr.

- Competitive salary.- Medical, dental, and vision insurance- 401(k)

Workplace Type

This is a fully onsite position in Durham,NC.

Application Deadline

This position is anticipated to close on Nov 6, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.