Description:

The Associate Scientist II is part of a team responsible for development of stable formulations, drug delivery systems, and manufacturing processes for recombinant adeno-associated virus (AAV) gene delivery products. In this role you will contribute to formulation development, characterization, and stability studies; design of drug product presentations; process development; clinical compatibility studies; and aseptic fills for GLP studies for multiple projects. You will work both independently and as a part of cross-functional teams on assigned projects, prioritize projects to meet departmental and organizational goals, and communicate results in technical reports and presentations.

Essential Position Requirements

Contribute to individual formulation development, characterization, compatibility, and stability studiesContribute towards individual drug product process design, characterization studies, and aseptic fills for GLP studiesContribute to pertinent regulatory submission sections including INDs, BLAs, and equivalentPerform relevant methods and techniques in support of pharmaceutical development goals

Skills:

Formulation, Chemistry, Formulation Development, Characterization, Compatibility, Stability, GLP, Product Process Design, Bioanalytical, Dynamic light scattering, spectrophotometry, HPLC

Top Skills Details:

Formulation, Chemistry, Formulation Development, Characterization, Compatibility, Stability, GLP, Product Process Design, Bioanalytical, Dynamic light scattering, spectrophotometry, HPLC

Additional Skills & Qualifications:

Bachelor’s degree in relevant scientific discipline with at least 2+ years relevant industry experience or Master’s degree in relevant scientific discipline with 1+ year of relevant industry experienceFamiliarity with theoretical and practical knowledge of formulation development and characterization principlesIdeally has an understanding of aseptic fill-finish of biologics, including unit operations, GMP requirements, media simulations, container/closure integrity, and regulatory requirementsIdeally has an understanding of bioanalytical techniques for product characterization and product stability evaluation, including dynamic light scattering, spectrophotometry, subvisible particle analysis, and HPLCAble to locate relevant scientific literature and standard industry guidance documentsAbility to perform routine data analysisAbility to perform experiments that support scientific activities and project goalsAbility to interpret data and draw conclusions.Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)Must be able to work collaboratively and effectively as part of a teamPrior industry experience preferred

Experience Level:

Intermediate 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 for other accommodation options.