Senior Director - Formulation & Process Development
- Employer
- Gilead Sciences, Inc.
- Location
- Foster City
- Salary
- See job description.
- Closing date
- May 29, 2021
View more
- Discipline
- Health Sciences, Clinical Research
- Position Type
- Full Time
- Job Type
- Staff Scientist
- Organization Type
- All Industry, Pharma
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Senior Director - Formulation & Process Development
United States - California - Foster City
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. Gileads 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 companys five core values. Thats 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
Senior Director - Formulation & Process Development
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.
Gilead Sciences has an opportunity for an experienced candidate in our Formulation & Process Development group at our Headquarters in Foster City, CA. We are seeking motivated, team-oriented individuals with scientific experience with lab work related to small molecules.
The Formulation & Process Development group located at the Foster City, CA Gilead headquarters is seeking a Senior Director to provide scientific, technical, strategic and hands-on support of drug discovery and product development of small molecules.
The qualified candidate should have experience and/or knowledge in pre-formulation, formulation and process development, Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs). Hands on experience in various delivery modalities (oral, inhaled or parenteral) to develop small molecules is strongly preferred.
The qualified candidate will be responsible for lead optimization, API form selection/characterization, pre-formulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up, process optimization, tech transfer based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.
Essential Duties and Job Functions:
- Must have sound understanding of the principles and practices of chemistry or pharmaceutical science and is able to integrate and apply this knowledge effectively to formulate new chemical entities.
- Experienced in formulation and process development and scale-up of small molecules drug products.
- Expertise in solid dosage form processing, parenteral and/or inhaled drug delivery technologies. Experience in development and scale up of hot melt extrusion processes
- Thinks critically and creatively and is able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports company interests.
- Knowledge of basic analytical skills required: HPLC, LC-MS, UV, solid state characterization.
- Excellent communication skills (both verbal and technical) and interpersonal skills are required Management skills
- Manages end to end complex projects to advance molecules across the pipeline
- Effectively collaborates in Discovery, Development, Commercial or CMC cross-functional teams to advance molecules into the pipeline
- Supervise scientists to advance molecules into the development
- Authors and reviews technical reports for internal knowledge transfer.
- Authors and reviews CMC sections of regulatory submissions. Assist teams to respond to regulatory questions
- Helps teams to plan, design, implement and analyze laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances.
- May make contributions to scientific literature and conferences through publication and presentation of research results.
- Demonstrates excellent writing and communication skills (both verbal and technical) and strong interpersonal skills.
- Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
Required Knowledge, Experience and Skills:
- 15+ years of experience with PhD in a related scientific discipline.
Preferred Qualifications:
- Ideal candidate will have degree in pharmaceutical sciences, chemical engineering, physical organic chemistry.
For jobs in the United States:
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.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Principal-Scientist-I---Formulation---Process-Development_R0019307
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