Product Transfer Scientist / Engineer

Description:

• Lead product/technology transfers, process development, product maintenance activities establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft chewable tablets, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms working closely with Manufacturing, Engineering, and Quality Teams.

• Generate technical protocols, reports, manufacturing documents and author Quality risk assessments to detect quality and technological risks.

• Lead development/engineering studies and batches.

• Manages and controls the development of each project’s work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct.

• Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters. Understands the product and process complexity and supports Validation and Quality in establishing the testing/characterization requirements for various process steps and overall manufacturing process validation.

• Serve as single point of contact for internal teams and external customers as transfer lead for all technology and product transfers.

• Provide proper levels of customer service and act as key interface with customers as needed.

• Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities. ·

• Support MFG efficiency and operations projects by interfacing with all internal departments (Quality, Engineering, Validation, Manufacturing, Planning, Supply Chain).

Skills & Qualifications:

• Bachelor’s degree in Industrial Pharmacy, Pharmaceutics, Chemical Engineering or related scientific field

• 4+ years of industry experience in technology/product transfers and process optimization in a GMP environment

• Familiarity with processing equipment and technologies utilized in GMP manufacturing facilities for solid dose, soft chewable tablets, non-sterile liquids and injectable platforms (at least in 2 areas)

• Experience authoring technical documents in support of all activities.

• Experience in leading technical cross-functional teams or relevant technical project management experience is highly desirable.

• Strong communication skills and computer literacy are mandatory.

• Experience with operational excellence, statistical analysis and ongoing process verification is desirable.

• Must be able to effectively interact with senior executives, senior technical managers, and external customers.

Keywords:

product transfer, pharma, GMP, technical writing, pharmaceutical, process technology, tech transfer, formulation, batch transfer, process development, formulation, batch transfer, upscaling, MS&T,

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.