Head of Analytical Development & Quality Control

We are seeking a results-oriented innovative broadly experienced CMC leader who will lead and manage Decipheras Analytical Development & Quality Control organization. The incumbent will continue to build and develop a team with technical competencies in method development and QC to support GMP manufacture and commercialization of small molecule ASO and biologic drug substances and a spectrum of dosage forms ranging from oral solid doses to and including injectables and topicals. Operating within a largely outsourced business model the successful candidate will have responsibility for all analytical development and quality control activities associated with Decipheras clinical-stage and commercial-stage portfolio of programs ranging from the discovery/development interface (lead optimization stage) through registration and commercialization and may include the evaluation of potential in-licensing candidates. The scope of the role will encompass analytical characterization of products/processes and the development qualification transfer and validation of analytical methods for QC release and stability testing of small-molecule and large molecule drug substance drug product intermediates starting materials excipients and packaging materials and components.

 The incumbent will model strategic thinking a global enterprise-wide vision and relentless focus on quality reliability consistency global regulatory acceptability capacity cost efficiency and operational performance. The role requires an individual who is highly organized detail-oriented timeline-driven decisive and capable of approaching the role from both a strategic and operational mindset. They will have significant experience in CMC development and commercialization of small and large molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercialization of biopharmaceutical products. Also critical is strategic and practical experience navigating the pharmaceutical/CMC regulatory landscape of the US EU and Japan and the ability to manage critical conversations with global regulatory agencies.  They will lead a team of talented analytical development and quality control professionals and serve as an integral member of the Pharmaceutical Development Leadership Team.

What Youll Do:

• Lead and manage an Analytical Development & Quality Control organization to enable successful development registration and commercialization of Deciphera and ONO Pharmaceuticals products in U.S. and international markets including partnering arrangements through geography specific distribution agreements and collaboration & license agreements.
• Establish and implement the enterprise-wide vision for the Analytical Development & Quality Control organization and set the strategy to enable global development and commercialization of Deciphera/ONO assets.
• Ensure cross-functional alignment and integration of Analytical Development & Quality Control strategy and deliverables with overarching Pharmaceutical Development & Manufacturing program/asset strategy.
• Define and manage scope milestones and interdependencies and assume ownership for budgets and timelines associated with analytical development and commercialization program deliverables.
• Establish selection of analytical service providers e.g. CROs and CDMOs based upon core capabilities capacity and track record of regulatory compliance and operational performance; establish KPIs to monitor site technical quality and business performance.
• Lead and oversee small-molecule ASO and biological molecule product/process characterization activities and the development validation and site implementation of IPC and QC methods for drug substance drug product intermediates starting materials excipients and packaging materials and components.
• Partner with Global Supply Chain Chemical Development Drug Product Development Pharmaceutical Engineering & Commercial Manufacturing Quality Assurance and related CMC disciplines as appropriate to ensure uninterrupted supply of CTM and commercial product.
• Oversee stability operations and reference standard management.
• Ensure high quality of technical reports controlled GMP documents (e.g. analytical methods and associated validation protocols specifications change controls LIRs SOPs etc.) and CMC content for Module 3 CTDs.
• Lead the development negotiation and operationalization of relevant sections of MSA and CSA agreements.
• Provide technical and business leadership in supporting in-licensing and/or out-licensing opportunities and external collaboration agreements.
• Provide leadership in regulatory CMC strategy and guidance in the development review and approval of Module 3 sections of CTD regulatory submissions written responses to regulatory authorities and TPP/QTPPs.
• Ensure success of analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
• Develop and maintain strong relationships with CRO and CDMO business partners and support Joint Steering Committee meetings as needed.
• Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address development and manufacturing risk.
• Represent Pharmaceutical Development & Manufacturing in meetings with FDA EMA and related regulatory authorities.

Qualifications :

Required Qualifications:

• PhD in Analytical Organic or Physical Chemistry with 13 years of experience OR M.S. degree in Analytical Organic or Physical chemistry or related life-sciences discipline with at least 18 years of experience in small and large molecule CMC development and commercialization.
• Track record of success in leading and managing small and large molecule analytical development and quality control programs in a 100% outsourced environment.
• Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
• Competency in developing implementing and delivering CMC project plans (milestones timelines resources etc.) to successful endpoints.
• Strong decision-making skills and ability to influence internal and external stakeholders.
• Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization.
• Ability to articulate complex issues and ideas with clarity to enable understanding and decision making in a multi-cultural environment and across multiple levels of the organization.
• Ability to influence cross-functionally to enable improvements and enhance performance across the entire Pharmaceutical Development & Manufacturing organization.
• Pragmatic solution-oriented thinker who possesses a can do and whatever it takes attitude coupled with excellent organizational and communication skills.
• Strong interpersonal skills with the ability to motivate and influence others negotiate during situational conflict and establish the best forward path in the face of competing points of view.
• Understanding of industry trends practices techniques and standards and associated impact on program strategy and execution.
• A high level of personal integrity reliability and trustworthiness.
• Ability to travel (10%) to CRO/CDMO domestic and international sites.

Preferred Qualifications:

• Experience in developing and commercializing drugs for oncology is strongly preferred.
• Experience in developing and commercializing either or both protein therapeutics produced via cell culture processes or ASOs is strongly preferred.
• A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired.

Additional Information :

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $218000.00 - $300000. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Remote Work :

No

Employment Type :

Full-time