Alcami Corporation ยท 1 week ago
Director, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation
Durham, NC
Full-time
Onsite
Director/Executive
12+ years expAlcami Corporation is a company focused on delivering reliable solutions for transformative medicines. They are seeking a Director of Laboratory Operations - Biologics to provide strategic and operational leadership for the Biologics department, ensuring high-quality services and efficient execution while fostering a collaborative environment.
Pharmaceuticals
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
Qualification
Required
Bachelor, Master, or Doctorate degree in Biochemistry or other science-related field
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 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
Preferred
Advanced degree preferred
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase