Sr/Principal Scientist, Formulation & Drug Product Development

Sr/Principal Scientist, Formulation & Drug Product Development – Perm – Rockville, MD. - $120,000 - $140,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Sr/Principal Scientist, Formulation & Drug Product Development in Rockville, MD.

Role Description

As the Senior/Principal Scientist, you will be a 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 lead and design 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.

• Lead program strategy and design individual formulation development, characterization, compatibility, and stability studies
• Accountable for individual drug product process design, characterization studies, and aseptic fills for GLP studies
• Review and author pertinent regulatory submission sections including INDs, BLAs, and equivalent
• Identify and develop new technology platforms, equipment, methods and techniques in support of pharmaceutical development goals
• Maintain familiarity with scientific literature and apply it appropriately to projects (such as evaluating new methodologies and techniques)
• It is imperative that company employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
• This role requires travel up to 10% of the time

Skills & Requirements

• Bachelor’s degree in relevant scientific discipline with at least 13+ years direct relevant experience or Master’s degree in relevant scientific discipline with 10+ years of relevant experience or PhD in relevant scientific discipline with 5+ years of industry or post-doctoral experience
• Proven track record of applying theoretical and practical knowledge of formulation development and characterization principles
• Experience with aseptic fill-finish of biologics, including unit operations, GMP requirements, media simulations, container/closure integrity, and regulatory requirements
• Experience with bioanalytical techniques for product characterization and product stability evaluation, including dynamic light scattering, spectrophotometry, subvisible particle analysis, and HPLC
• Experience authoring pertinent regulatory submission sections including INDs, BLAs, and equivalent
• Substantial knowledge of relevant scientific literature and standard industry guidance documents
• Ability to independently plan and perform experiments that support scientific activities and project goals
• Ability to interpret data, draw conclusions, and recommend next steps
• Ability to develop a wide range of methodologies/technologies and perform advanced data analysis
• Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)
• Ability to lead internal and external cross-functional projects
• Must be able to work collaboratively and effectively as part of a team
• Prior industry experience preferred

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1140200


Rodzaj pracy
Obszar specjalizacji
120,000 - 140,000
Nr ref.: