Director, Lab Operations Development Services and Biologics

Alcami Corporation•Wilmington, NC

26d•Onsite

About The Position

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 – Development Services and 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 is responsible for the success of department 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 and or small molecule 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.

Requirements

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.

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.