Senior Manager, Analytical Development and Quality Control

Company Description

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera's FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:

Patients - places the importance of improving the lives of patients and their caregivers at the forefront of every day's work.

Accountability - for our performance and the way we work with coworkers and other stakeholders.

Transparency - in our intent and actions to both internal and external stakeholders.

Honesty and Integrity - fosters trust and strives to deliver on our and the company's promises.

Stewardship - values and uses wisely the resources and investments provided to the company.

Job Description

The Senior Manager, Analytical Development and Quality Control has responsibility for leading and managing pharmaceutical analytical development and cGMP quality control activities associated with development and commercialization of Deciphera's small-molecule assets. This function operates within a virtual (100% outsourced) business model and the incumbent is responsible for 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, review/approval of protocols, methods, reports, batch records and related cGMP source documents, oversight of stability operations and reference standard management, and transfer/site implementation of analytical methods to support future supply chain expansion. This person additionally will have responsibilities to actively manage data and document by using various software like Excel, istability, JMP, and Veeva for clinical and commercial projects. The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

This position will report to the Director of Analytical Development and Quality Control and will be based out of the Waltham, MA office. As a virtual organization, we are enabling flexibility and choice between individuals and managers to maintain our strong culture of collaboration and allow hybrid opportunities on a need basis.

What You'll Do:

• Provide technical expertise for the technology selection, method development, and method validation for analytical methods at CDMO partners and 3rd party analytical labs for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
• Manage/lead the site implementation at CDMO partners of IPC and analytical/QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
• Manage analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
• Provide technical expertise for the life-cycle management of analytical methods from early-stage development through commercialization.
• Manage stability operations. Coordinate stability activities at CDMOs and compile/analyze stability data/reports using iStability and JMP.
• Manage reference standard and critical reagent programs.
• Conduct tracking/trending of batch release data and stability data.
• Support product investigations and oversee analytical laboratory deviations/ investigations at CDMOs.
• Review/approve controlled cGMP documents, e.g., analytical methods and associated validation protocols, specifications, stability protocols, change controls, LIRs, etc.
• Manage/perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
• Author/review/approve development reports for data integrity and regulatory compliance; author/review/approve CMC content incorporated into Module 3 sections of CTD regulatory submissions for translational accuracy.
• Provide expertise for the evaluation/selection of analytical CROs/CDMOs based upon core capabilities and regulatory compliance.
• Support cGMP audits of CDMO laboratories.
• Author and/or review standard operating procedures (SOPs) relating to analytical development and quality control.
• Build and maintain effective communication with CDMOs and deliver analytical/QC objectives in accordance with project timelines and budgets.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment

Qualifications

• B.S. degree (with at least 10 plus years' experience) or an M.S. degree (with at least 8 plus years experience) in analytical chemistry, pharmaceutical chemistry, pharmacy, or a closely related discipline with progressively responsible experience as an Analytical Scientist/Chemist/Manager in pharmaceutical product development or related life sciences discipline.
• Qualifying experience as an Analytical Scientist/Chemist/Manager must include the experience in development, validation, qualification, tech transfer and implementation of analytical test methods in support of formulation/process development, pre-clinical development, clinical development, commercial production, and stability testing of drug substances and products.
• Qualifying experience as an Analytical Scientist/Chemist/Manager must include the experience in writing, reviewing, and following SOPs, test methods and other cGMP documentation such as qualification protocols, method transfer protocols and validation protocols
• Hands-on experience and/or familiarity with HPLC/UPLC, GC, KF, spectroscopy (UV, FTIR, etc.), particle size, XRPD, ICP-MS/OES, microbial testing, dissolution and other common analytical techniques used for small molecule drug substance and solid oral dosage drug product testing.
• In-depth, working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories.
• Must be able to demonstrate an in-depth understanding of CMC regulatory requirements for product registration (NDA, MAA, etc.)
• In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of NDA and MAA registration.
• In-depth experience in CDMO management employing cross-functional collaboration skills.
• Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
• Ability to work successfully in a team/matrix environment and independently with good judgement and strong organization skills.
• Ability to convey both written and verbal information effectively and efficiently.
• Ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
• Ability to travel (15%) to CDMO domestic and international sites.

Additional Information

What Deciphera will Bring:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Internal rewards and recognition program

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.