Sr Research Scientist I (Associate Director) Analytical Operations

Location
Morris Plains, New Jersey
Posted
Sep 16, 2021
Ref
2396400
Required Education
Doctorate/PHD/MD
Position Type
Full time
Sr Research Scientist I (Associate Director) Analytical Operations
United States - New Jersey - Morris Plains

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Essential Duties and Job Functions:
  • Manages a group of scientists that perform protein structure and characterization studies
  • Leads analytical method development projects and qualification for protein and structure characterization activities.
  • Demonstrates technical proficiency, scientific creativity and independent thought in experimental design and strategy.
  • Manage projects in executing project plans and coordinates with team to characterize molecules, degradation pathways, and define critical quality attributes.
  • Defines, conducts, and instructs group in comparability studies.
  • Advises and manages analysis of in-process samples and product related impurities as needed.
  • Works in a matrixed environment and effectively communicate of ideas, results, and problems.
  • Conceives and optimizes experiments and proactively troubleshoots problems.
  • Identifies areas for improvement and efficiency gains.
  • Leads method transfers to QC and external CRO/CMO laboratories.
  • Maintains full working knowledge scientific literature for techniques and instruments and applying appropriately to projects.
  • Represents the company at national/international conferences.
  • Manages multiple projects and ensures analytical deliverables are met within timelines.
  • Responsible for conducting scientific research for the development of drug candidates.
  • Works on moderately complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of intelligence, logic, ingenuity, and creativity.
  • Initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
  • Presents results of work, interprets data, and draws conclusions within the context of the work.
  • Experience with Regulatory Filings and authoring relevant sections is desired.
  • Works under supervision of scientific directors to analyze laboratory. experimentation and advance the development of state-of-the-art techniques to characterize drug product formulations and processes.
  • The applicant is also expected to exercise considerable latitude thus thinking critically and creatively to determine appropriate resources for resolution of problems. Therefore, the candidate must have strong organizational and planning skills.
  • Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports company interests.
  • Demonstrates ability in developing methods, techniques, and evaluation criteria for obtaining results and interpreting experimental outcomes.
  • Provides expertise and advises for troubleshooting issues with assays in QC, Technical Services, and manufacturing.
  • Draft and revise standard operating procedures for analytical methods.
  • Interacts with Process Sciences, Manufacturing Sciences & Technology, Quality Control, Project Management Office.
  • Acts a mentor and technical trainer for staff to junior staff.


Required Education, Knowledge & Skills
  • PhD in life sciences or engineering with 3+ years of experience in biotechnology or pharmaceutical development
  • Significant knowledge of analytical methods used in biopharmaceutical development including mass spectrometry.
  • Extensive experience in operating mass spectrometers and processing related data (i.e. peptide mapping, intact analysis).
  • Has independently or as project management, led the development of new assays and transferred them to GMP environment.
  • Strong understanding of pharmaceutical product development and experience working with monoclonal antibody or ADC products.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to lead a high-performing team. People managing experience preferred.
  • Familiarity with GLP/GMP practices and regulations. Experience working in a regulated environment is preferred.
  • Has experience in leading project teams and mentoring of junior scientists.
  • Must be proficient with MS Office applications. Working knowledge of LIMS systems preferred.



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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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