Director, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation

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 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.

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

• 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.

• 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.

• 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…