- Lead device development teams in d evi c e e v a l u a t i o n, d e s i g n , a n d o pt i m i z a t i o n a s r e l a t ed to c o m b i n a t i on drug pro d u c t s .
- Co n d u c t c o m p a t i b i li t y s t u d i es w i th dru g - d e l i v e r y d e vi c es (pr e - f ill e d s y ri n g e s , a u t o - i n j e c t i n g s y s t e m s , e t c .) a n d o t h er c o n ta i n e r cl o s ure s y s te m s .
- Lead t he t e c h n o l o g y t r a n s f er of c o m b i n a t i on pro du c t m a n u f a c tur i ng pro c e ss es to cl i n i c a l a nd c o m m er c i al m a n u f a c tur i ng s i tes a n d a ss i s t i n q u a l i t y i n v e s t i g a t i o n s .
- Position may include managing one or more device engineers.
- E ff e c t iv e l y c o m m u ni c a t e i d e a s , p r o j e c t g o a l s , a n d re s u l ts to t e am m e m b e r s ac r o s s cr o s s - f u n c t i o n a l r o l es /d e p a r t m e n t s .
- Q u a l i f i ed c a n d i d a t es s h o u l d b e s e l f - m ot i v a t ed a n d or g a n i z e d, f a m ili ar w i t h t h e r e l e v a nt li t erature, e n j o y sci e n t i f i c i n v e s t i g a t i o n a n d t h i n k i n g , proa c t i v e l y i d e n t i f y i ss u e s , a n d d e v e l op s o l u t i o n s i n a c o ll a b o r a t i v e m u l t i d i sc i p li na r y e n vi r o n m e n t.
- P art i c i p a t e i n ne w f or m u l at i on e v a l u a t i o n a nd o p t i m i z at i on as re l at e d to c o m b i n a t i o n d r u g - d e v i c e products (pr e- f il l ed s y r i n g es , a uto -i n j e c t i n g s y s te m s , e t c .). O v er s ee e x p e r i m e n ta t i on c o n d u c t ed at c o n tra c t si tes as w e l l as pro c ure i n - h o u s e e q u i p m e n t a s n e e d e d t o m a n a g e p r o j e c t -r e l at e d d e v e l o p m e n t a c t i vi t i e s .
- E x p e ri e n c e w i th d e vi c e d e s i gn c o ntr o l , c o m b i n a t i on product d e s i g n veri f i c at i on a n d va l i d a t i o n, cr e a t i on a n d m a i nt e n a n c e of d e s i gn h i s to r y f i l e s , a n d q u a li t y s y s t em r e g u l at i o n s ( Q S R s ).
- G o o d v erb a l , w r i tt e n, a nd i n terper s o n a l c o m m u ni c at i o n s k ill s are r e q u i r e d .
- Experience in cross-functional team leadership is preferred .
- M u s t b e a b l e t o w ri te cl e a r , c o n c i s e, a nd er r o r- f r ee d o c u m e n t s .
- M u s t b e a b l e t o e x er c i s e j u d g m e n t w i t h i n we l l - d e f i n ed a n d e s ta b li s h e d p r o c e d u r e s a n d p o l i c i es i n order to d e t er m i ne a n d t a k e a p propr i ate a c t i o n.
- E x p e ri e n c e wor k i ng w i t h D r ug P r o d u c t/ D e v i c e C MOs i s d e s i r e d .
- W o r k i ng k n o w l e d g e of t h e FD A , cG M P , a nd G C P s ta n d a r d s , as w e l l as re g u l at o r y g u i d a n c e.
- 8+ y e ars of re l e v a nt i n d u s t r y e x p e r i e n c e a n d a B S d e gree i n a sci e n t i f i c f i e l d. F i e l d o f s tu d y pre f er r e d : C h e m i c al E n g i n e e ri n g , M e c h a ni c a l E n g i n e eri n g, Bi o m e d i c al E n g i n e e r i n g, Material Science Engineering , o r r e l a ted.
- 6+ years of relevant industry experience and a MS degree s ci e n t i f i c f i e l d. F i e l d o f s tu d y pre f er r e d : C h e m i c al E n g i n e e ri n g , M e c h a ni c a l E n g i n e eri n g, Bi o m e d i c al E n g i n e e r i n g, Material Science Engineering , o r r e l a ted.
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Senior Engineer II, Device Development - Foster, CA, United States - Workday
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
G il e ad S c i e n c e s , I n c . i s a r e s e a rc h - b a s ed b i o p h ar m a c e u t i c a l c o m p a n y f o u n d e d i n 1987. T o g et h er w e d e l i v er l i f e -s a v i n g t h e r a p i es to p at i e n ts i n n e e d. W i th the c o m m i t m e n t a nd dr i v e y o u b r i n g t o t h e wor k p l a c e e v e r y d a y , y ou w i l l b e p art of a t e am t h at i s c h a n g i ng t h e w or l d a nd h e l p i n g m ill i o n s of p e o p l e l i v e h e a l t h i er, m ore f u l f ill i ng l i v e s . Our wor l d w i d e sta f f i s a c l o s e co m m u ni t y where y o u can s e e t h e ta n g i b l e re s u l ts of y o ur c o n t r i b u t i o n s , where e v e r y i n d iv i d u al m at t er s , a nd e v e r y on e h a s a c h a n c e to e n h a n c e t h e i r s k ill s t h r o u g h o n g o i n g d e v e l o p m e n t. Our sc i e n t i f i c f o c us h a s re s u l t e d i n m a r k et e d p r o d u c ts th a t are b e n e f i t i ng h u n dre d s of t h o u s a n ds of p e o p l e, a p i p e l i ne of l a t e -s ta g e drug c a n d i d a tes, a n d u n m atch e d p a t i e nt a cc e s s progra m s to e n s ure m e di c at i o n s are a v a i l a b l e t o t h o s e who c o u l d ot h e r w i s e n o t a ff ord th e m . B y j o i n i ng G il e a d , y o u w i l l f urther our m is s i on to a d dre s s u n m et m e di c al n e e ds a n d i m pro v e l i f e b y a d v a n c i ng t he c are of p a t i e n ts w i th li f e - threat e n i ng d i s e a s e s .
Q u a l i f i ed c a ndi d a t es w i l l fo c us on t h e d e v e l o p m e n t o f d e v i c es a n d d r u g - d e vi c e c o m b i n a t i on pro d u c ts s u c h a s pre - f il l ed s y r i n g es a n d a u t o - i n j e c tor s . W e a r e se e k i ng a m ot i v a te d , d e t a i l - ori e n t ed i n d i v i d u a l w i th cross-functional leadership experience.
Location:
Foster City, CA
S pe c if i c Job R esponsibilities
K n o w led ge , E xpe r ien c e, and S k i ll s
Basic Qualifications:
OR
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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.
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