Senior Technical Officer

Title: Senior Technical Officer

Location: Be******** China

Division: Center for Vaccine Innovation an********, CVIA, ChemistryManufacturing & Controls & Non-Clinical Tox Funct******** CMC


PATH is an international organization that drives transformativeinnovation to save lives an******** health, especially among womenan********. We accelerate innovation across five platforms-vacc**************** ******** ******** an******** an******** innovations-thatharness our entrepreneurial ******** scientific an******** healthexpert******** an******** for health equity. By mobilizing partnersaroun******** world, we take innovation to scale, working alongsidecountries primarily in Africa an******** to tackle their greatest healthneeds. Together, we deliver measurable results that disrupt the cycle ofpoor health.

PATH’s Center for Vaccine Innovation an******** brings together ourexpertise across every stage of the long an******** process of vaccineresearch, ******** an******** to make lifesaving vaccines widelyavailable to children an******** across the world. CVIA’s currentportfolio encompasses more than two dozen vaccines either in developmentor already in use to protect against 15 different diseases. Our focus ison vaccines to address the leading diseases that claim children’s livesworldwide: pneumon******** diarrheal ******** an********; as well asother global health pr******** such as polio an********. We work inpartnership with national health m******** pharmaceutical manufacturers,******** international financing an******** organ******** an********others.


PATH’s CVIA conducts vaccine development an******** technology researchan******** introduction activities in the following disease area********malar******** diarrheal diseases an********, respiratory tractinfections an********, HPV an********-borne viral ******** as well as inthe cross-cutting area of Maternal Immunization.


Responsibilitie********

Strengthen cGMP activities an******** of vaccine an********manufacturers in China (70%) an******** Southeast Asian countries (30%)ensuring that regulatory inspections (NRA, WHO) yiel******** an********outcomes.

Provide continue******** an******** support for ensuring robustan******** manufacturing of quality vaccines an******** that meets localan******** demands.

Become a resource an******** truste******** by way of building strongcollaborative professional relationship with vaccine an********manufactures in China an******** Southeast Asia. Leverage externalSME******** as neede******** achieve the objective.

Provide technical / manufacturing guidance to vaccine an********manufacturers an******** them improve an******** technical capabilitiesfor robust an******** operation that supplies forecaste********. Help topursue WHO prequalification or maintain WHO prequalification status.



Review plans against Quality Assurance an******** Control requirementsincluding WHO Prequalification standards. Analyze r********opportunities an********, seek solutions an******** projectimplementation to ensure achievement of targete********.

Provide strategic an******** guidance to the PATH China officean******** CVIA CMC function

Conduct technical (process developmen******** assurance) due diligenceof vaccine an******** manufactures as required.

Provide technical review of pharmaceutical plans an********documentation relative to vaccine an******** manufacturing facilities.

Engage as neede**************** Consultant support in delivering setgoals.
Time allocation: 70% for China an********% for the rest of Asia- 70%for vaccines an********% for drugs.

Require******** an********:

A Relevant Bachelor's degree plus a minimum of 15 years of experiencein vaccine/biologic******** manufacturing under compliant environment(cGMP) that is suitable for regulatory submission an********.

Plann******** con******** collaborat******** managing or overseeingcGMP manufactur******** an********, an******** due diligence activities.

Experience with pharmaceutical quality operations is critical for thejob as is auditing experience. Certification from a Quality Organization(CQA from ASQ, for example) is a big plus.

Knowledge of vacc******** drug an******** development an******** (cGMP)in develope******** developing countries is a plus.

Experience in applying US an******** (including WHO) qualityrequirements in the context of regional an******** regulatoryexpectations.

Proven ability to conduct internal or external quality assuranceauditing of manufacturing facilities an******** an******** developingremediation plan for execution.

Experience managing complex international projects involvingvacc******** ******** or biologics.

Experience in technical report revie********

Written an******** communication skills in Chinese an******** arerequired.

Ability to travel internationally an******** China up to 50 percent.

Must have legal authorization to work in China.

PATH is dedicate******** building an inclusive workforce where diversityis valued.

PATH is an equal opportunity employer. Every qualifie******** will beconsidere******** employment. PATH does not discriminate base********race, color, rel******** gen******** sexual or******** gender ********genetic ******** age, national or******** marital status, disabilitystatus, political ******** military or protecte******** status, or anyother characteristic protecte******** applicable fe******** state, orlocal la********



HOW TO APPLY: All applications are made online. For a full jobdescription an******** apply onl******** please access via this link(******** ) or visit PATH website (********) then go to(Resource******** listing******** Clinical an********). Deadline forapplication******** December 1, 2017.