Associate Scientist, Analytical Ops (Open)
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Role and Responsibilities:
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing
(PDM) workplace, you will be part of a team that is changing the world and helping millions of
people live healthier, more fulfilling lives. You will see the tangible results of your contributions,
where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting
hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient
access programs to ensure medications are available to those who could otherwise not afford
them. By joining PDM at Gilead, you will further our mission to address unmet medical needs
and improve life by advancing the care of patients with life-threatening diseases.
Essential Duties and Job Functions:
- Manages method validation and transfer for late stage development and commercial products based on small molecules, polypeptides and biologics
- Plans, designs and implements laboratory experimentation for method validation and
method transfer, performs review and evaluation of data
- Authors reports, protocols, test methods, and other documentation
- Serves as Subject Matter Expert on analytical techniques (LC, dissolution, Karl-Fischer, GC, particle characterization). Knowledge of techniques used in analysis and characterization of peptides and biologics is desired.
- Troubleshoots failures/investigations effectively and efficiently with minimal supervision
- Provides guidance to junior team members on experimental design, data interpretation and troubleshooting
- Supports regulatory filings, may support regulatory responses to questions related to methods and validation
- May manage an entire project or aspects of multiple projects. Works closely with internal customers, CMOs and external vendors/contractors to ensure analytical deliverables are met per the project timelines
- Participates in cross-functional project teams
- Provides high quality analytical support, meets aggressive timelines while ensuring
compliance to SOPs, protocols, cGMPs and safety regulations
- May work on problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work
- Excellent scientific and business communication skills (both verbal and written) are required
- Excellent interpersonal skills are required
Knowledge, Experience and Skills:
- Experience validation and transfer of analytical methods for small molecules, peptides, biologics
- Hands on experience/knowledge with standard microbiological techniques, including aseptic technique, bioburden testing, bacterial endotoxin testing and general microbiological techniques is desired
- Knowledge of industry guidance documents (ICH, USP, Ph. Eur, etc.) highly desirable
- Ability to think critically and creatively and have strong organizational and planning skills
Minimum Education Requirements:
- 8+ years of experience with a BA or BS degree in Chemistry or Biology.
- 6+ years of experience with MS degree in Chemistry or Biology.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead