JOBS - Senior Director, Small Molecule CMC — Boston
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NEWS Senior Director, Small Molecule CMC Hiring Manager: Vice
Date Opened: October 2020
The Senior Director, Small Molecule CMC will report to the Vice
President CMC. S/he will be responsible for designing
phase-appropriate synthetic routes and formulations and
manufacturing small molecule drug candidates completely through
external CDMOs. S/he will also play an important role in partnering
with business development on due diligence of potential new assets.
The role requires excellent leadership and networking capabilities
to optimize the integration of internal domain expertise with
external resources that include subject matter experts in contract
process/formulation development and manufacturing.
Reports to Vice President, CMC and works across the entire
Key Relationships: Nonclinical and Clinical Development,
Pharmacology, Regulatory Affairs, Quality, Clinical Supply
Management, Program Management, Strategic sourcing, Finance,
A PhD in Chemistry, Pharmaceutics, or related life sciences
field is desirable.
Minimum of 15 years’ biopharmaceutical industry experience in
CMC and expertise in solid oral formulation development and/or
analytical science is preferred.
Excellent track record in managing third-party CRO/CMO partners
and associated service providers to develop and manufacturing
Demonstrated abilities and hands-on experience in all
CMC-related activities including drug substance, drug product, and
analytical from lead optimization phase through registration.
Track record in devising and implementing CMC strategies from
concept phrases through GMP manufacturing for development
Strong knowledge of FDA, EMEA, ICH and other relevant
CMC/Quality regulations and guidelines.
Author and review CMC sections of regulatory submissions and
supportive source documents such as technical reports.
Voracious intellectual curiosity, innovation and creative
problem solving with an entrepreneurial spirit.
Self-motivated, able to influence/motivate cross-functional team
members to work collaboratively and achieve program goals.
Ability to think critically with a keen sense of urgency and
Proven ability to quickly synthesize and communicate concise,
logical, fact-based presentation and make recommendations to
internal and external stakeholders and represent CMC in
company-wide program teams.
Excellent teamwork skills and the ability to understand and
respond to the needs of multiple disciplines. Ability to preform in
fast-paced, dynamic, constantly evolving environment.
Excellent organizational skills, time management skills and
attention to detail.
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