Alcami Corporation · 1 month ago
Director, Lab Operations Development Services and Biologics
US-NC-Wilmington
Full-time
Onsite
Director/Executive
12+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines. The Director, Laboratory Operations – Development Services and Biologics will provide strategic, technical, and operational leadership for the biologics department, ensuring high-quality services and efficient execution while driving growth and client satisfaction.
Pharmaceuticals
Responsibilities
Provide overall direction and leadership for biologics and small molecule development programs within laboratory operations, ensuring alignment with company strategy and client expectations
Develop and implement a 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 clients, ensuring exceptional customer service and responsiveness
Oversee analytical services including HPLC, Dissolution, bioassays, bioseparations, characterization, 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 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 small molecule and large molecule 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; Advanced degree preferred with 12+ years of relevant experience within the Pharmaceutical Industry
Must have at least 6+ years of experience in management roles
Strong technical skills for area managing
Strong business acumen
Strong understanding of company SOPs, and regulatory guidance documents
Strong knowledge of safety procedures and quality compliance for assigned area
Thorough knowledge of GMP requirements and regulatory compliance
Proven experience in CDMO/CMO environment required
Strong experience with client audits
Excellent analytical and problem-solving skill, with the ability to think strategically
Strong attention to detail as well as time and resource management
Good presentation skills
Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction
Promote a safe environment for work
Comply with the general policy of the company
High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction
Ability to develop and manage a high-performance team focused on quality, accountability, and meeting and exceeding expectations
Communicate well orally both for internal customers and team members as well as external customers
Ability to write reports and business correspondences
Ability to listen and respond well to external customers, partners, and colleagues at all levels
Highly goal and result oriented
Prioritizes tasks according to business objectives and can pursue several objectives simultaneously
Can work independently with a high degree of self-motivation
Knows how to obtain support from different collaborations
Tackles problems with enthusiasm and curiosity
Treats colleagues at all levels with respect
Very effective listening skills with the ability to hear attentively and process information correctly
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