Director Biologics Pivotal Formulation Process Development
Director Biologics Pivotal Formulation Process Development
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$ 226185 - 292710
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
TheDirector Biologics Pivotal Formulation and Process Developmentwill be responsible for leading pivotal and commercial drug product process development and enabling successful pivotal and commercial regulatory filings for biologics in multiple therapeutical areas. This role is also expected to work collaboratively with crossfunctional stakeholders and contribute to the overall biologics CMC development strategies.
Responsibilities:
Establish and maintain a stateoftheart lab that can enable drug product process development for liquid and lyophilized dosage forms.
Establish pivotal and commercial fill and finish workflow that would meet cGMP requirements.
Ensure scalability of DP process and successful technical transfers to inhouse or external GMP manufacturing facilities; oversee GMP manufacturing master batch record generation and support manufacturing investigations.
Drive technical innovation and encourage scientific investigations; influence internally and externally through publication and presentations; lead by example.
Establish documentation templates and review/approve technical documentations from internal team or contracted organization; oversee data generation data integrity and ensure compliance and excellence from internal and contract organizations.
Hire mentor and develop a team of scientists with a focus on technical excellence as well as teamwork and collaboration across all PDM organizations; grow employees as formulation and drug product leads for pivotal biologics programs
Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/BLA; support associated agency interactions and productrelated inspections.
Set strategies and develop longrange plans in line with Gilead strategic priorities to deliver on Gileads longterm ambitions.
Ensure strong relationships with key stakeholder functions including Analytical Development Cell Culture Purification Research Clinical Operation and Program Strategy Teams by providing technical and strategic inputs.
Qualifications:
BA in Chemical EngineeringBioengineeringPharmaceutical Science or related fields with 12 years of industrial experience OR
MS in Chemical EngineeringBioengineeringPharmaceutical Science or related fields with 10 years of industrial experience OR
Ph.D. in Chemical EngineeringBioengineeringPharmaceutical Science or related fields with 8 years of industrial experience
Biologics CMC development experience with people leaderaccountabilities required.
Extensive experience with late stage formulation development and clinical inuse evaluation for monoclonal antibodies bispecifics antibodydrug conjugates fusion proteins and other complex biologics formats.
Extensive experience with drug product fill and finish process development; process validation and GMP manufacturing support of liquid and lyophilized products and prefilled syringe; experience of IND and BLA submissions.
Well versed in FDA EMA and ICH guidelines and GLP/GMP requirements relating to drug product development.
Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
Established people leader with experience in leading teams and growing talents.
Strategic thinker with business acumen.
*Preferred Qualifications:
Advanced degree in Chemical Engineering Bioengineering Pharmaceutical Science or related field(s)
Experience working with CDMOs is highly preferred.
Gilead Core Values:
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking PersonalResponsibility)
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights 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.
Required Experience:
Director
Employment Type
Full-Time
