Senior Director, Quality Control Analytical Sciences
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Scientist — Quality Control Biologics- Analytical Method Validation and Transfer at Gilead Sciences
Foster City, California, United States
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalIndustries
Requirements
- PhD in Chemistry, Biochemistry or related field OR Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR Bachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience OR Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience OR High School Degree and 10+ years of relevant experience
- Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends
- In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
- Preferred: Experience authoring validation protocols and reports for commercial or late-stage products
- Preferred: Experience developing method transfer plans, including authoring gap assessments
Responsibilities
- Support Commercial analytical method validations and transfers
- Support compendial review program and specification setting strategies
- Contribute to monitoring QC test method execution
- Lead the analytical lifecycle management of Commercial biologics drug substances and drug products
- Develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
- Develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
- Exercise judgment and independently determine and take appropriate action where precedent may not exist
- Work with senior management to develop and ensure the implementation of Company-wide long-term solutions
- Motivate and engage individuals
- Influence process and outcomes across functions
- Support future laboratory work
- Support Commercial QC team
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the employment type for this position?
This is a full-time position.
Is this role remote or does it require working at a specific location?
This information is not specified in the job description.
What key skills and experience are required for this Scientist role?
The role requires experience over a broad set of Quality Control sub-functions, extensive knowledge of industry best practices and trends, in-depth understanding and application of GMP principles in the US and internationally, and the ability to develop solutions to complex problems with ingenuity and creativity.
What is the company culture like at Gilead Sciences?
Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with every employee playing a critical role in scientific innovations; they value great leaders who foster an inclusive environment where employees feel developed and empowered.
What makes a strong candidate for this Quality Control Scientist position?
Strong candidates will have proven ability to exercise judgment, independently determine and take appropriate action where precedent may not exist, along with experience in analytical method validation, GMP principles, and solving complex problems creatively.
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees