Tech Transfer Lead

Job Title: Tech Transfer LeadJob Description

The Tech Transfer Lead serves as a subject matter expert in manufacturing operations, working closely with quality, regulatory, manufacturing, engineering, and R&D teams. This role coordinates the transfer and implementation of projects and technologies from development groups and customers to the manufacturing site. The Tech Transfer Lead designs and optimizes manufacturing processes for new or modified products to ensure robust, reliable, and compliant production at commercial scale. The position covers the full product lifecycle, including development, stability studies, validation batches, and cleaning validation and verification activities.

Responsibilities

• Lead the execution of new product technology transfer and cleaning projects, ensuring timely, compliant, and successful delivery.
• Prepare the manufacturing site for new product introduction, including readiness of equipment, processes, and documentation.
• Communicate plant-related issues and tasks to project teams, particularly regarding scale-up, new equipment, validation activities, and batch manufacturing.
• Conduct risk assessments, such as FMEA, to design robust and reliable manufacturing processes.
• Act as the primary plant liaison for manufacturing processes across internal departments and external units.
• Draft master batch records and protocols for development, stability, and validation batches.
• Translate development findings into scalable, reproducible manufacturing processes suitable for commercial production.
• Provide technical documentation and input for regulatory submissions and responses.
• Serve as the primary contact for manufacturing-related inquiries and resolution of technical issues.
• Support scale-up evaluations and technical assessments related to manufacturing changes and process improvements.
• Assist with investigations, corrective action plans, and material change requests to maintain product and process integrity.
• Develop and execute validation protocols and investigative studies for processes, equipment, and cleaning activities.
• Review technology transfer documentation in collaboration with regulatory and other stakeholders to ensure accuracy and compliance.
• Coordinate with external customers and vendors to support technology transfer and manufacturing initiatives.
• Track and report on departmental assignments, including project time tracking, APQRs, and product-related activities.
• Support the onboarding of new department employees and provide first-level technical guidance to team members.
• Identify process gaps and develop action plans to address and resolve them, driving continuous process improvement.

Essential Skills

• Bachelor's degree in science, engineering, or equivalent experience.
• 3-5 years of experience in product development, process scale-up, or technology transfer.
• Minimum 2-3 years of experience working within a cGMP manufacturing setting, preferably in the pharmaceutical industry.
• Experience working in aseptic, cleanroom environments.
• Experience with technology transfer for processes and equipment, including quality, process optimization, and process improvement.
• Experience writing and owning change controls within a regulated environment.
• Strong interpersonal skills with the ability to work effectively across all organizational levels and cross-functional teams.
• Excellent oral and written communication skills, including technical writing and presentations.
• Expertise in cGMP manufacturing principles and practices.
• Knowledge of equipment and process engineering related to manufacturing operations.
• Understanding of quality systems and requirements in a regulated manufacturing environment.
• Experience with product formulation and sterile manufacturing processes.
• Familiarity with packaging, warehousing, and distribution operations.
• Knowledge of purchasing, contracting, and enterprise systems used in manufacturing organizations.

Additional Skills & Qualifications

• Experience with pharmaceutical industry systems and tools, including TrackWise or similar change control and quality management platforms.
• Demonstrated ability to lead cross-functional projects and manage multiple priorities in a fast-paced environment.
• Proven capability in conducting risk assessments such as FMEA to strengthen process robustness.
• Experience preparing documentation for regulatory submissions and responding to regulatory inquiries.
• Background in cleaning validation and verification studies for manufacturing equipment and facilities.
• Experience drafting and reviewing master batch records and validation protocols.
• Ability to mentor and provide first-level support to new team members within the department.
• Strong analytical and problem-solving skills with a focus on continuous improvement.

Work Environment

The Tech Transfer Lead works in a highly regulated cGMP manufacturing environment that includes aseptic, cleanroom areas and sterile production operations. The role involves close collaboration with quality, regulatory, engineering, manufacturing, R&D, and supply chain functions, as well as interaction with external customers and vendors. Work is performed using enterprise systems and quality management tools, such as change control platforms, to manage documentation, validation activities, and project tracking. The environment emphasizes adherence to standard operating procedures, robust documentation practices, and strict compliance with regulatory and quality standards. Appropriate cleanroom and aseptic gowning procedures apply when working in controlled areas, and the role may require flexibility in working hours to support production schedules, validation activities, and project timelines.

Job Type & Location

This is a Contract to Hire position based out of Wilson, NC.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Wilson,NC.

Application Deadline

This position is anticipated to close on Aug 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.