Scientist, Analytical Development
About The Position
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We are seeking a highly motivated individual to join our commercial analytical development (AD) team. We are looking for candidates with a background in cell and gene therapy analytical sciences, commercial MSAT, commercial QC, and/or CMC analytical control strategy to join us as Sr QC specialist / Scientist at our Fredericks, MD location. The individual will join our AD commercial life cycle management team (CLCM) and will work within cross functional groups with MSAT, process development, quality, and regulatory to provide analytical support to commercial assets.
Requirements
- PhD Degree and 1+ years of related industry/academic experience
- Master’s Degree and 4+ years of related industry/academic experience OR Bachelor’s Degree and 6+ years of related industry/academic experience
Nice To Haves
- Advanced knowledge of Immunology and Cell Therapy
- Previous experience in commercial Manufacturing, QC, and/or MSAT
- Previous experience in analytical development
- Proven track record of method and experiment troubleshooting
- Understand ICH guidelines and other regulatory guidelines and requirements
- Advanced knowledge in analytical techniques such as Flow cytometry, ddPCR, Potency and compendial methods techniques
- Project management experience and proficient in project management tools
- Excellent interpersonal, verbal and written communication skills
- Ability to influence and lead without authority, influencing others and achieving desired outcomes through persuasion, collaboration, and building trust
- Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others
- Ability to function efficiently and independently in a changing environment
- Work independently. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
- Self-motivated, detail-oriented, excellent interpersonal skills, and willing to accept temporary responsibilities outside of initial job description
Responsibilities
- Support MSAT organization for technical investigations
- Support MSAT organization with analytical laboratory testing
- Support QC organization for technical assessments & investigations
- Serves as an analytical team representative in Cross-functional forum
- Create analytical roadmaps and timelines with trackable key milestones
- Define and track project decisions, risks, action items, sampling plans, etc.
- Facilitate the efforts of life cycle method deployment to commercial Quality Control.
- Collect feedback from Analytical sub-teams to continue improving business processes
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
