Senior 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 . The Senior Manager is an emerging leader within Technical Operations and is recognized as a subject matter expert both within and outside the department, representing Technical Operations in cross-functional settings and with external suppliers. The Senior Manager delivers on complex outsourced manufacturing activities for drug product and is responsible for ensuring positive and effective relationships with all stakeholders.

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 .

C om 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 and leads resolution of quality investigations * 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 and process changes.

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 10+ y ear s , MS 7+ y ears or P h D w it h 5+ y ears of r e l e v ant w ork e x perie n c e * Advanced knowledge of drug product manufacturing * Ex perie nc e w it h Pro c e ss V a li d a ti o n * Excellent interpersonal and collaboration skills * Knowledgeable in QbD and designed experiment methodology and implementation * Proven ability to interact effectively and give presentations to senior management * Demonstrated flexibility to accommodate changes in responsibilities or project priorties * Advanced knowledge of 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 ograms * 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 * Experience with 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 * 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. ) * 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 * 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.

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