Job details
Job type full-time
Full job description
Gilead sciences is continuing to hire for all open rolesOur interview process may be conducted virtually and some roles will be asked to temporarily work from homeOver the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For current gilead employees and contractors:
Please log onto your internal career site to Apply Now.
Job description
Senior associate scientist/ manager, analytical outsourcing (onsite or remote)
The senior associate scientist/ manager level position in gilead’s analytical outsourcing organization will be responsible for managing analytical activities outsourced to third party contract laboratories (ctls) and contract manufacturing organizations (cmos)We are seeking candidates with working experience collaborating with outsourced testing laboratories with prior experience in biologics in a pharmaceutical development or quality control settingThis individual will be a key point of contact between gilead and one or more external partners, responsible for the supplier relationship and performance management.
Specific responsibilities
Manages outsourced analytical and quality control testing activities for biologics bulk drug substance, drug products, and parenterals.
Serves as the primary day to day contact to support the relationship between gilead and assigned contract organizations.
Develops strategy for management of outsourced testing needs, considering timelines, risk mitigation and business priorities.
Develops, executes and ensures compliance to procedures for outsourced testing oversight.
Coordinates with legal and quality assurance groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements.
Reviews and facilitates approval of proposals, work orders, and changes of scope.
Assists in transfer of new projects to various contract organizations.
Coordinates testing schedules based on program requirements by interfacing with colleagues in biologics, analytical operations and counterparts in chemical development and formulation/process development.
Monitors and troubleshoots key outsourced testing activities via email, teleconferences and site visits.
Executes strategies that drive effective operational performance and service levels at contract organizations.
Communicates risks and delays to management and technical leads on a timely basis.
Participates in quality audits as required.
Supports strategic business and quality compliance processes and changes by participating in working groups and acting as business process owner for system changes as needed.
Provides input for budgeting based on outsourced analytical needs.
N e g o t i a t e and m an a g e k ey ctl a g r e e m e n t s (msas, sows, supply agreements, pricing, etc.)
Effectively communicate project, performance, and resource issues to management and project teams.
Knowledge & skills:
A b ili t y t o i n f l uence and w o r k w e l l w i t h o t he r s i n a p r oa c t i v e and con s tr u c t i v e m anne r .
St r o n g co mm un i c a t i on s k ill s, b o t h v e r bal and w r i tt en, w i t h a l l l e v e l s o f an o r g an i z a t i on.
A n i ndependent se l f - s t a rt er w i t h t he ab ili t y t o r e s o l v e supp l ier performance cha ll en g es and i m p l e m ent process and/or system i m p r o v e m en t s.
P r o v en ab ili t y t o p r ob l em so l v e , bu il d s t r o ng r e l a t i onsh i ps, and t o o r gan i z e e ff e c t i v e l y.
B us i ness ac u m en w i t h an ab ili t y t o an t i c i pa t e op e r a t i onal i ssues and proactively r ec o mm end mitigations/s o l u t i ons.
D e m on s tr a t ed ability to multi-task and t o work a c r oss multiple m u l ti -na t i onal s i t es and diverse cultures
Education & experience
A bachelor’s degree and a minimum of seven (7) years of experience, or a master’s degree with a minimum of five (5) years of experience or a phd.
Experience with analytical/qc testing for large molecules/biologics.
Preferred/desired experience
Direct experience managing supplier relationships and outsourced analytical/qc testing.
Experience with parenteral and/or solid oral dosage forms.
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.yello.co/external/form/24a8ou4jf5ul3ckq7lo_cg
About gilead
Gilead sciences, incIs a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical needWith each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the worldGilead’s therapeutic areas of focus include hiv/aids, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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As an equal opportunity employer, gilead sciences incIs committed to a diverse workforceEmployment 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 lawsIn 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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, gilead has made the decision to require all u.sEmployees and contractors to receive the covid-19 vaccines as a condition of employment“full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administeredAnyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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