Location US-NC-Durham

ID 2025-1699

Category

Bio Analytical

Position Type

Full-Time

Working Hours

1st Shift: Monday - Friday, 8:30am - 5:30pm

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Manager, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the biologics department of Bioseparations & Mass Spectrometry within Laboratory Operations. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The ideal candidate will be a collaborative leader with a proven track record in biologics development and testing, who thrives in a client-driven CDMO environment.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

• Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness.
• Oversee analytical services supporting biologics and other large molecules, including bioseparations using a variety of chromatographic and electrophoretic methodologies, characterization, release, stability testing, and other specialty studies.
• Extensive experience with mass spectrometry as applied to biologics, including method development, characterization, troubleshooting of instrumentation, data interpretation, and application of advanced analytical techniques to complex biologics.
• Translate client needs into actionable project plans while balancing scientific rigor with business requirements.
• Serve as subject matter expert in Biologics for internal and external stakeholders.
• Ensure projects are executed on time, on 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 to meet the current and evolving needs of the business through effective selection, training and development, coaching and 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.
• Stays current on industry and regulatory laboratory trends and adapts the quality systems, practices, and procedures, as necessary.

• Doctorate degree with 8+ years, or Master’s degree with 10+ years, or Bachelor’s degree with 12+ years of related experience 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.

• Proven experience in CDMO/CMO environment desired.
• Thorough knowledge of GMP requirements and regulatory compliance.
• Understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and analytical methodology (HPLC/UPLC, electrophoresis, mass spectrometry, AUC, UV/Vis, potency assays, etc.).
• Demonstrated success in building and leading teams, driving operational performance and achieving business growth.
• Excellent communication and interpersonal skills with ability to effectively represent the organization holistically to external clients.
• Demonstrated business acumen with ability to balance scientific excellence and commercial priorities.
• Demonstrated experience representing analytical or biologics operations during regulatory inspections.
• Strong organization and management skills required.
• Record of accomplishment in change management and proven ability to build teams.
• Self-motivated with high-energy and an entrepreneurial team spirit, willing to get “hands on” to build the business.
• Excellent written and verbal communications and presentation skills required.
• Strong skills with Microsoft Office (Word, Excel, and PowerPoint) required.

• Up to 5% travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

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