Job Openings

Technical Transfer Leader

TECHNOLOGY TRANSFER LEADER
Raleigh, NC

SUMMARY
Provides direct customer service and project management support for technology transfer in the development and manufacture of clinical and commercial drug products. Acts as the on-site customer advocate for Tech Transfer; provides continuous support both to the customer and internal departments to drive tech transfer projects to successful completion on time and within budget.

RESPONSIBILITIES

• Supports site management in obtaining information for customers to further expand the base of information following acceptance of a project into APP Pharmaceuticals.
• Creates and executes technology transfer protocols and Studies for pre-validation activities.
• Creates and executes Process Validation protocols for product validation activities.
• Creates technology transfer reports to assist the Validation Department with validation protocol generation, determining critical test  parameters and finalizing processes in preparation for commissioning and validation activities.
• Review validation protocols for technology accuracy.
• Assists with the development of support documentation utilizing tools such as, MS Project, Production Information Package (PIP) level II and other relevant new product introduction documents and databases.
• Act as a project manager for new product introductions and involved with the distribution of technical information to function departments.
• Creates and tracks tasks to assure compliance to goals and objectives are met.
• Develop, organize and conduct studies or experiments to identify, resolve an or correct manufacturing problems, process improvements, efficiency improvements, and produce reports to substantiate findings, and establish validation acceptance criteria or other special projects as directed by management
• Facilitates communication with clients and internal management, acting as the technology transfer advocate and liaison, as well as all other duties assigned.

REQUIREMENTS

• Minimum Bachelor Degree or equivalent with 1-4 years experience, or AAS with 4 years relevant experience.
• Must be able to focus on computer terminal for long periods of time.
• Ability to clearly read and write English.
• Ability to work effectively under pressure to meet established deadlines.
• Ability to stand, sit for long periods of time, walk, drive and lift 0-15 lbs.
• Specific vision requirements include reading on computer and written documentation.
• Frequent use of the computer is required, along with the ability to clearly see and focus on objects and colors at a close and far distance with good depth perception.
• Must have the ability to wear a respirator for a period of time and met personnel gowning requirements for the Aseptic Area.

EOE/AA M/F/D/V