Head of Analytical Development & Quality Control
WALTHAM, MAPosted 30+ days ago
Job summary
Job post source
This job is directly from Deciphera Pharmaceuticals
Job overview
The Head of Analytical Development & Quality Control leads Deciphera's analytical and quality control teams to support drug development and commercialization, ensuring compliance and operational excellence.
Responsibilities and impact
The role involves managing analytical development and QC activities for small and large molecule drugs, overseeing method development, regulatory submissions, vendor management, and cross-functional collaboration to ensure product quality and supply continuity.
Compensation and benefits
The salary range is $218,000 to $300,000 with an annual bonus, comprehensive medical, dental, vision insurance, 401(k) with company match, generous parental leave, and opportunities for personal and professional growth.
Experience and skills
Requires a PhD with 13+ years or MS with 18+ years in CMC development and commercialization, strong vendor management, regulatory knowledge, leadership skills, and experience in outsourced environments; oncology and biologics experience preferred.
Career development
The company offers outstanding culture and opportunities for personal and professional growth within a dynamic pharmaceutical development environment.
Work environment and culture
Deciphera values diversity, equal employment opportunity, and fosters a culture of integrity, collaboration, and continuous improvement in a supportive work environment.
Company information
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies with a strong commitment to quality and regulatory compliance.
Team overview
The candidate will lead a talented team of analytical development and quality control professionals and be part of the Pharmaceutical Development Leadership Team.
Application process
Applicants are encouraged to apply online as part of Deciphera's mission to improve cancer patient lives; specific application instructions or deadlines are not provided.
Unique job features
The role offers leadership in global regulatory strategy, management of outsourced analytical services, and involvement in cutting-edge drug development projects including small molecules, ASOs, and biologics.
Company overview
Deciphera Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines to improve the lives of cancer patients. They generate revenue primarily through the sale of their FDA-approved drug, QINLOCK, which treats gastrointestinal stromal tumors (GIST). Founded in 2003, Deciphera has a rich history of leveraging its proprietary kinase switch control inhibitor platform to create targeted therapies. The company is headquartered in Waltham, Massachusetts, and continues to advance its robust pipeline of drug candidates through clinical trials.
How to land this job
Tailor your resume to emphasize leadership in analytical development and quality control within outsourced environments, highlighting your experience with small molecule, ASO, and biologic drug substances across multiple dosage forms.
Focus on showcasing your strategic vision and ability to align analytical development with global pharmaceutical development and manufacturing programs, including your success in managing budgets, timelines, and vendor partnerships.
Apply through Deciphera Pharmaceuticals' corporate career site, LinkedIn, and other reputable job boards to maximize your application visibility for this leadership role.
Connect with current Deciphera employees in the Pharmaceutical Development or Quality Control divisions on LinkedIn; open conversations by referencing recent company milestones, expressing enthusiasm for Deciphera’s innovative oncology portfolio, or asking about team culture and key challenges in the Analytical Development group.
Optimize your resume for ATS by incorporating keywords such as 'analytical method development,' 'quality control,' 'CMC regulatory strategy,' 'GMP compliance,' 'outsourced CRO/CDMO management,' and 'Module 3 CTD submissions' to ensure your resume passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored resume customization, identify multiple application channels, and find LinkedIn contacts to network with, allowing you to focus your energy on preparing for interviews and strategic job search activities.
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