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Senior Director, Small Molecule CMC

Company: Boston Pharmaceuticals
Location: Cambridge
Posted on: September 17, 2020

Job Description:

JOBS - Senior Director, Small Molecule CMC — Boston Pharmaceuticals WHO WE ARE WHAT WE DO PIPELINE PARTNERING PATIENTS NEWS Senior Director, Small Molecule CMC Hiring Manager: Vice President, CMC

Date Opened: October 2020

Position Summary:

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.

Key Relationships:

Reports to Vice President, CMC and works across the entire enterprise.

Key Relationships: Nonclinical and Clinical Development, Pharmacology, Regulatory Affairs, Quality, Clinical Supply Management, Program Management, Strategic sourcing, Finance, Business Development.

Qualifications:

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 pharmaceutical products.

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 candidates.

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 ownership.

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.

CLICK HERE TO APPLY Return to Open Positions Career Opportunities

Boston Pharmaceuticals

55 Cambridge Parkway

Suite 400

Cambridge, MA 02142

info@bostonpharmaceuticals.com

partnering@bostonpharmaceuticals.com

Boston Pharmaceuticals © 2020

Legal Notice | Privacy Policy

Keywords: Boston Pharmaceuticals, Cambridge , Senior Director, Small Molecule CMC, Other , Cambridge, Massachusetts

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