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Manager, Drug Product Manufacturing

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

Ve r t e x s T e c h n i c al O pera t i o n s D r ug P r o d u c t t eam h a s an e x c i ti ng a nd c h a l l eng i ng o p p o r t un it y f or y ou to f a c i li t a t e r ap i d c om m e r c i a li z a t i on of n e w p r o d u ct s u t i li z i ng t r ad i t i o n a l and c o n t i n u o u s m a n ufa c t uri n g t e c h n o l ogy i n o ur i n d u s t ry -l e ad i ng Q u a l i t y by D e s i g n ( Q b D ) en v i r o n m e n t. Ve r t ex has fo ur s i g n i fi c ant c omm e r ci al p r o d u ct s i n ad d i t i on to m u l ti p l e new m o l e c u l e s in v a r i o u s s t ages of cl i n i c al de v e l o p m en t . T h e s u c c essf u l ca n d i d a t e w i l l ha v e t he o p p or t u nit y t o add s i g n i fi c ant v a l ue i n se v e r al a r eas:

Pro c e s s Va l i d a ti o n and N ew P r o d u c t Lau n c h

* D e v e l o p and e x e c u t e p ro c ess v a li d a ti o n s t r a t eg i e s un d er qu i c k t i m e l i nes by w o rk i ng w it h c r o s s -f u n c t i o nal t eams i n c l u d i ng f or m u l a t i on d e v e l o p m en t , a na l yt ic a l , q ua l it y , s u p p l y ch ai n a nd r egu l a t ory t o en su r e c r ea ti v e a n d ef f ici e nt i m p l e m e n t a ti o n. * F o rm u l a t e v a l i da t i o n m as t er p l an s , v a li d a t i on p ro t o c o l s, v a li da t i on r e p ort s , c o n ti n ued p r o c ess mo n i t ori n g p l a n s and s t a t i s t i c al s amp l i ng p l an s , amo n g o t her i m p ort a n t str a t e gic d o c um e n t s .

Com m e r c i al P r o d u ct i on

* S u p p o r t o ng o i ng i n t e r n a l and ex t e r nal c om m e r c i al m a n u fa c t uring a c ti vi ti es * Re s o l v e c o m p l ex c om m e r ci a l m anufa c t uring i ss u es * C o n d u c t c om m e r ci a l c o n t i n u e d p r o c e s s m o n it o r i ng a n d p r o c ess i m pro v e m e n t s . T hi s i n c l u des the o p p ort u n it y t o app l y s t a t i s t i c a l p r o c e ss c o nt r ol t o r e c o g n i z e d a t a tre n ds a n d t h en i m p l e m e nt i m pro v e m e n t s.

Te c h n o l ogy Tra n sfer

* Di r e c t t e c h n o l o gy t r ansfer t o enab l e b o t h c o n t i n u o u s a nd t r ad i t i o n al m a n ufa c t uring a t e xt e r nal su p p l i e r s. * Pro v i de t e c h n i c al i n p u t t o s u p p l y ch a i n, q ua l it y , a nd r egu l a t ory to f or m u l a t e gl o b a l r egu l a t ory strategy for q u a l i fi c a t i on of n ew m anu f a c t uring s i t es. * T h e c a n d i da t e m u st be a n e x c e ll e n t c o l l abor a t or a n d p r oven te c h n i c al l e ader w i t h e x per ie n c e in a cG M P p h a rm a c e u t i c al drug pro d u c t m anufa c t uring en v i r o n m e n t . T h e s u cc e s sful c an d i d a t e w i l l ha v e a s o l i d b a c k g r o u n d i n s ol i d oral d o s a ge fo r m m anuf a ct ur i ng.

M i n i m u m Q u a li fi c a ti o ns:

* D eg r ee in a p h a rm a c eu t ic a l s c i en c e or e n gin e e r i ng d i s c i p l i ne: BS and 5+ y ear s , MS 3+ y ears or P h D w it h 2 + y ears of r e l e v ant w ork e x perie n c e * Ex perie nc e i n c G MP m a n ufa c t ure of c o mm e r c i al or l a t e p h a se c l i n i c al p r o d u ct s . Ex perie n c e wi t h t e c h n o l ogy t r ansfer and s c a l e up i s a p l u s. * Pro c e s s D e v e l o p m e nt of s o l i d oral d o sage for m s a nd a s o u n d un d e r s t an d i ng of t he p h a rm a c e u ti c al de v e l o p m e nt pro c e s s. * Pro v en ab i l i t y to s o l v e c omp l e x te c h n ic a l and e q u i pme n t q u a li f i c a t i o n c h a ll e nges u s i ng a r a ti o na l , s c i e n ti f i c app r o a c h * Profi c i e n c y wi t h Q u a l i t y by D e s i gn ( Q b D ) c o n c ep t s and d es i g n of experime n t s r eq u i r ed. * F a m i l i a r it y w it h s t a t i s t ic a l p ro c ess c o n t ro l (S P C ), c om p l ex d a t a ana l y s i s, m a t hem a ti c al mo d e li ng a nd o p ti m i z a t i on s o ftware ( l i k e M a tl a b, J M P, e t c. ) i s a p l u s . * M u st b e a c om m it t ed t e am p l a y er and c o ll a b o r a t or * D e m o n s t r a t es c ompe t en c y i n t h e p r i n c i p l es a nd p r a ct i c e of c GM P s and a ss o ci a t ed r eg u l a t ory c o n s i dera t i o ns in a p h a rm a c e u t i c al e n v i r o n m e nt * W i l li n g ness a nd A b i l i t y to t r a v el up t o 30% of t he t i m e.

P r e f e rre d Q u a li fi c a ti o n s :

* E x perie nc e w it h Pro c e ss V a li d a ti o n * Ex perie nc e w it h c om m e r c i al m anufa c t uring of b i o l og i c s a n d/ o r pa r e n t e r al p r o d u ct s i s a p l us b u t n o t r eq ui r e d.

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Manager, Drug Product Manufacturing, Executive , Boston, Massachusetts

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