Director, Manufacturing Technical Services

Alcami Corporation•Morrisville, NC

2d•Onsite

About The Position

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.

Requirements

Bachelor’s degree required (Science or Engineering related preferred).
10+ years of CDMO or pharmaceutical experience required, 6+ years of management experience required.
Prior pharmaceutical experience in sterile aseptic filling and visual inspection is required; prior CDMO experience preferred.
Solid understanding of FDA and ANEX 1 aseptic guidelines and regulations.
Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.
Strong knowledge of pharmaceutical regulatory requirements and cGMP required.
Sterile drug product manufacturing experience in the CDMO/CMO industry.
Technology transfer process.
Product transfer and product management.
Fluent in single use system, and current processing technologies.
Familiar with mAbs and filling of these products in vials and PFS.
Managing batch records, preparing protocols and reports, process qualification and equipment configuration reporting.
Customer interaction and presentation of technical recommendations.
Defense of regulatory processes to appropriate regulatory agencies i.e. FDA, EU, etc.
Knowledge of quality systems and processes, change control, CAPA and data integrity required.
Knowledge of aseptic processing of commercial or clinical parenteral products.
Have participated in /or lead regulator audits.
Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
Strong business acumen.
Good presentation skills.
Strong understanding of industry requirements, and regulatory guidance documents.
Strong knowledge of safety procedures and quality compliance.
Strong knowledge of cGMP requirements.
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.
Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently.
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.
Develop and manage a high-performing team, focused on quality, accountability, meeting and exceeding expectations.
Communicate well orally both for internal customers and team members as well as external customers.
Write reports and business correspondence.
Listen and respond well to external customers, partners, and colleagues at all levels.
Highly goal and result oriented.
Prioritize tasks according to business objectives and can pursue several objectives simultaneously.
Works independently with a high degree of self-motivation.
Collaborates effectively with others cross functionally to accomplish goals.
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.

Nice To Haves

Prior CDMO experience preferred.
Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.

Responsibilities

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 of technical recommendations.
Demonstrates strong technical understanding of sterile operations including aseptic fill, terminal sterilization, and lyophilization.
Manages batch records, prepares technical reports, processes qualification and equipment configuration reporting.
Prepares and carries out presentations related to the Company or project information.
Ensures that deliverables are met, or expectations are proactively managed towards alternative solutions.
Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer
Manages the day-to-day operations for assigned area.
Ensures all staff members are fully trained.
Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and interests.
Recruits, trains, develops and retains staff for the effective process of departmental operations.
Other duties as assigned.