Director, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation

Director, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation Location US-NC-Durham ID 2025-1728 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? Job Summary The Director, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the Biologics department within Laboratory Operations.

The Director, Laboratory Operations - Biologics is responsible for the success of site operations and achieving company goals. 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.

On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Provide overall direction and leadership for biologics programs in the Bioseparations, Mass Spectrometry, and Bioassay teams within laboratory operations, ensuring alignment with company strategy and client expectations. Develop and implement a biologics growth strategy to expand capabilities, revenue, and market share.

Partner with Business Development to support client presentations, proposals, and scientific discussions. Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness. Oversee analytical services supporting biologics, including bioassays, bioseparations, characterization by mass spectrometry and other pertinent methodologies, release, stability testing, and other specialty studies.

Provide technical and regulatory expertise for biologics method establishment and testing strategies across all phases of development. 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.

Formulate and implement policies that meet compliance and operational expectations. 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. Develop and report metrics and key performance indicators to monitor laboratory compliance and performance. Other duties as assigned.

Qualifications Bachelor, Master, or Doctorate degree in Biochemistry or other science-related field; Advanced degree preferred. 12 years of pharmaceutical laboratory experience with 6 years experience in people leadership roles. Knowledge, Skills, and Abilities Proven experience in CDMO/CMO environment required. Thorough knowledge of GMP requirements and regulatory compliance.

Strong understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and demonstrated experience with relevant analytical methodologies (HPLC/UPLC, Electrophoresis, Mass Spectrometry, ELISA, Potency Assays, etc.). Demonstrated success in building and leading teams, driving operational performance and achieving business growth. Excellent communication, negotiation, and interpersonal skills with ability to effectively represent the organization holistically to external clients.

Strong 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. Travel Expectations Up to 10% travel expected. Physical Demands and Work Environment 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. 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.