Description:

Onsite at ATO - 3 days onsite Looking for someone who can work independently to co lead a product. Technical Skills: Drug product fill finish processing Holistic DP process knowledge. Technical transfer drug product manufacturing regulatory filings. Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance while also leading the charge in innovative process improvement strategies. - Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation filtration filling vials/syringes/devices and lyophilization of parenteral products. - Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites. - Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing Process Characterization Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing. - Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change efficiency and foster strong relationships. - Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause. - Authors and reviews guideline documents technical protocols reports product impact assessments and regulatory submissions - Identifies and implements operational opportunities for current and new sterile operations. Preferred Qualifications - Advanced degree in Chemical/Biomedical Engineering Pharmaceutical Sciences Chemistry/Biochemistry or Biotechnology or related field - 10 years of drug product process development experience in the pharmaceuticals/biotechnology industry - Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations - Experience with unit operation for parenteral manufacturing i.e. filling filtration mixing etc. specifically lyophilisation would be an advantage. - Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing filtration mixing filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability. - Project management skills including the ability to manage multiple projects and evaluate project resource requirements. - Strong knowledge of Quality systems Drug Product Manufacturing and Validation. - Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role as well as a demonstrated proficiency with the principles of Technical Writing.

Skills:

process development, Drug product Manufacturing, chemical engineering, biomedical engineering, biochemical engineering, biochemistry, lyophilization, quality system

Top Skills Details:

process development,Drug product Manufacturing,chemical engineering,biomedical engineering,biochemical engineering,biochemistry,lyophilization,quality system

Experience Level:

Expert Level

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.