Director, Manufacturing Technical Services

Director, Manufacturing Technical Services

Location:

US-NC-Morrisville

:

Category:
Manufacturing

Position Type:
Full-Time

Working Hours:

1st

Shift: Monday
- Friday, 8:00am - 5:00pm

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, Manufacturing Technical Services provides strategic and operational leadership in a fast‑paced environment by steering comprehensive manufacturing support for Drug Product Development. This role serves as the principal subject matter expert in the Sterile manufacturing area, ensuring clients receive elite technical and engineering solutions for their manufacturing processes. The Director partners closely with Commercial and Business Leaders to drive budgeting, establish long‑term project timelines, and deliver high‑level technical recommendations.

The Director continuously evaluates cutting‑edge technology to maintain Alcami's position at the forefront of the industry. The Director, Manufacturing Technical Services oversees a department of technical professionals executing tech transfers of formulation and process development programs into GMP manufacturing. Key accountability includes ensuring absolute regulatory compliance, authoring foundational guidance documents, and instilling strict adherence to standard operating procedures. Additionally, the Director designs and executes robust resource plans that achieve client and organizational benchmarks in safety, quality, and productivity.

• 100% on‑site position.
• 1st
  
  Shift: Monday
  - Friday, 8:00am - 5:00pm.

• Leverages deep technical expertise to guide complex programs and drive high‑impact, positive outcomes for clients.
• Communicates transparently and effectively with internal executives and client leadership to align project plans, scope, and status updates.
• Authorizes and approves standard operating procedures (SOPs), test procedures, analytical specifications, and comprehensive technical summary reports.
• Provides technical support to Business Development and Technical Evaluation teams by meeting with prospective clients to define scope of work, provide technical evaluation and costing for projects. Develops strategy to grow accounts and expand business relationships.
• Assists in developing and implementing key strategic policies and procedures.
• Represents organization in client and regulatory audits and inspections.
• Provides training and guidance to Managers, Staff and Technical Transfer Engineers.
• Responsible for assisting the team with planning of all activities associated with the formulation, process development, technology transfer of projects originating from FD or external clients and moving into the GMP areas.
• Ensures adherence to organizational and regulatory requirements.
• Works with Senior Leadership to devise and implement strategy to develop the department; provides input to capital expenditure planning.
• Assists in engineering batches, scale‑up to commercial manufacturing, troubleshooting of existing commercial manufacturing processes.
• Evaluates current capabilities against client needs and industry trends to identify opportunities to expand our services.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Assures that processes are safe, reproducible, cost effective, environmentally sound and can be successfully validated and transferred to production operations.
• Attracts, develops, and retains 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.
• Provides engineering guidance and requirements to tech transfers and client installations.
• Provides client support in new and novel technologies and therapies.
• Ensures defense of regulatory processes to appropriate regulatory agencies i.e., FDA, etc. as required.
• Demonstrates strong customer interaction and presentation…