Technology Transfer Leader

Join to apply for the Technology Transfer Leader role at Planet Pharma

6 days ago Be among the first 25 applicants

Join to apply for the Technology Transfer Leader role at Planet Pharma

POSITION SUMMARY :

The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and I&D teams. The position is responsible for assisting with and / or coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumbent is also responsible for designing manufacturing processes of varying degrees of difficulty for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. This position plans, coordinates, and oversees the product life cycle which includes development, stability, product validation batches, and cleaning validation / verification studies. The incumbent will provide necessary leadership to organize project teams, define milestones, support gap analysis and assist in qualification and validation activities.

Principal Activities

Oversee execution of new product technology transfer and cleaning projects ensuring they are completed on time, on budget and in a manner consistent with regulatory and quality requirements.

Job Description

POSITION SUMMARY :

The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and I&D teams. The position is responsible for assisting with and / or coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumbent is also responsible for designing manufacturing processes of varying degrees of difficulty for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. This position plans, coordinates, and oversees the product life cycle which includes development, stability, product validation batches, and cleaning validation / verification studies. The incumbent will provide necessary leadership to organize project teams, define milestones, support gap analysis and assist in qualification and validation activities.

Principal Activities

Oversee execution of new product technology transfer and cleaning projects ensuring they are completed on time, on budget and in a manner consistent with regulatory and quality requirements.

Communicates plant issues and tasks with the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches.

Coordinates the preparation of the manufacturing site for the manufacture of new products.

Assesses manufacturing processes using FMEA or other risk analysis method(s) and uses the results to design robust manufacturing processes.

Plant liaison for manufacturing processes to other departments / business unit / marketing unit outside of the plant.

Prepares master batch records and protocols for the manufacture of development, stability, and validation batches. Translates development findings into manufacturing processes.

Identifies and implements practices and procedures designed to provide robust manufacturing processes.

Provides information and documentation needed for regulatory submissions or responses as required.

Serves as the plant focal point for channeling all manufacturing related questions and issues for resolution.

Conducts scale-up evaluation and support

Provides technical assessment of changes in manufacturing through appropriate review of documentation and supporting data

Develops and executes necessary investigative studies and validation protocols as required

Reviews as required various technology transfer documentation with regulatory and other appropriate groups

Coordinates project requirements with outside customers and vendors as required

Coordinates, tracks and reports on routine departmental assignments such as project time tracking, APQRs schedules, Product Modernization and Continue Process Validation monitoring as required

Assist in the training of new employees to the Technology Transfer department

Provides first level of support and direction to departmental staff members as required

Where gaps exist – develops action plans to improve

Requirements

Minimum of a Bachelor's degree in science, engineering, or equivalent experience

Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment

Strong interpersonal skills; must be able to interact effectively at all levels of the company

Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities

3–5 years experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise

Technical Area of Expertise cGMP manufacturing, equipment and process engineering, quality, product formulation, filling and packaging, sterile manufacturing technique, warehousing, distribution, purchasing, contracting, financial, administrative and enterprise systems.

Pay ranges between $55-61 / hr based on experience

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

Seniority level

Not Applicable

Employment type

Employment type

Full-time

Job function

Industries

Staffing and Recruiting

Referrals increase your chances of interviewing at Planet Pharma by 2x

Sign in to set job alerts for "Technology Transfer Specialist" roles.

Quality Assurance, Pharmacovigilance (PV) Director

Raleigh-Durham-Chapel Hill Area $170,000.00-$220,000.00 2 weeks ago

Senior Research Scholar - Mass Spectrometry Metabolomics

Polysomnography Technician Registered- Sleep Lab

Polysomnography Technician Registered- Sleep Lab

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr