CMCVP

面议

苏州市

刷新时间：2023-10-18

职位描述

Deneugen is a multi-national biotech company with operation
presence in Boston USA and Suzhou China. Backed by accumulated deep knowledge from
neurotoxin research and top venture capital funds, Deneugen is aiming at
developing and delivering the best-in-class neurotoxin product for addressing
unmet medical needs. We are looking for a head of CMC development to lead CMC
development activities in China.

Job Description



The Head of CMC Development will build and lead
multi-disciplinary CMC Teams of supporting clinical trial application and all
development activities. This role is responsible for developing and overseeing
the internal and external execution of CMC technical operations strategy
associated with the overall Product strategy.

The Head of CMC will represent CMC function and collaborate
cross-functionally with other product development team members. This role provides
an in-depth understanding of drug development processes and ensures all CMC
aspects are carefully considered cross-functionally as part of the program and
product clinical development strategy. This role works closely with key
stakeholders and subject matter experts from internal/external organizations
and ensure on-time execution of all CMC deliverables. This role reports out
regularly to corporate executive Team on status of CMC operation team goals,
deliverables, and timelines and proactively escalates issues with action plans.
As this position is a key interface with internal and external stakeholders and
executive team, strong leadership, CMC development knowledge, project planning
and communication skills are essential.



Key Responsibilities:

Liaison of China CMC team with
global CMC team and executive team
Build China CMC organization, plan
and oversee all internal/external CMC activities
Lead the development of
product-specific CMC strategy, create CMC timeline and maintain CMC
strategy in alignment with project development milestones and expectations
Lead and drive the selection process
for CDMO/CRO and other eternal R&D partners
Conduct contract negotiation and due
diligence activities for external R&D partner collaboration
Lead China government relation work
for CMC development compliance confirmation and improvement
Lead and oversee technology transfer
and development/manufacturing/testing/logistics CMC activities with
CDMO/CRO
Represent China CMC team in development
gate reviews and escalate issues with global team
Drive and facilitate option analysis
and decision making for CMC Team deliverables
Represent China CMC Team and
collaborate cross-functionally with other product team members; ensure
alignment of Product Team on CMC strategy, timelines, and deliverables
Develop, implement, and track
progress of CMC goals and dashboards
Lead CMC dossier preparation and
supporting documents collection for product clinical trial
application/market application filings
Management China CMC Team daily
operation, resolve conflicts and create a high-performance team culture
and identify opportunities for team members to grow

Basic Qualifications:

PhD with 8+ years of experience or
MS with 10+ years of biotechnology or pharmaceutical or CRO/CDMO industry
experience, including 5+ years of experience leading cross-functional
teams, programs within key Technical Operations functions (e.g., Process
Development, Manufacturing, Quality, Supply Chain and Regulatory CMC)

Preferred Qualifications

Proficient with therapeutical
biologics early-to-mid phase CMC development
Expertise with at least one
biologics CMC tech area, pertaining to microbial/mammalian cell line
development, manufacturing process development, analytics, quality and
formulation development
Extensive experience with managing
external R&D partners
Experience with supporting and/or
leading cross-functional CMC teams
Experience with preparing dossier
for supporting IND/CTA filing
Experience with China government
affairs
Broad understanding of the
multidisciplinary tech operation functions contributing to effective and
efficient CMC development
Strong leadership and collaboration
skills to lead high performing, cross-functional teams in a matrixed
environment
Excellent presentation skills to
different audiences, including to senior management
Excellent communication, influencing
skills and ability to deal with ambiguity and change
Prior experience in external
partnership relationships and governance process
Ability to recognize strategic
implications of complex product development activities and effectively
manage them cross-functionally to optimize outputs      

其他要求

招聘人数：5人
职能类别：研发科学家/领军人才

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。