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Manager, Quality Control

4 months ago

Watertown, United States Deciphera Pharmaceuticals Full time
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.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

See here for more details on our portfolio.

Job Description

What's In It for You:

If you have been working in the lab environment for the past few years and want to grow in the latest trend of working in the virtual organization while still delving into the science of drug development, this is the role you are looking for.

The Role:

The Manager, Quality Control has responsibility for actively overseeing cGMP quality control activities associated with development and commercialization of the company's small-molecule assets. This function operates within a virtual (100% outsourced) business model and the incumbent will be responsible for oversight of Quality Control activities of drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. This person will also review and approve protocols, methods, reports, batch records and related GMP source documents, as well as have oversight of stability operations and reference standard programs, 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 is an on-site position at our Waltham, MA office with up to 10-20% domestic and international travel required, and will report to the Associate Director, Analytical Operations and Quality Control.

What You'll Do:
  • Review/approve controlled GMP analytical documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
  • Compile data and conduct tracking/trending/statistical analysis of batch release data and stability data.
  • Support Root Cause Analysis and product impact assessment for investigations because of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
  • Manage the continued expansion of existing and the implementation of new departmental document and data management systems.
  • Manage the life-cycle performance of analytical methods from development through commercialization.
  • Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
  • Author and/or review standard operating procedures (SOPs) relating to quality control.
  • Manage stability activities at CDMOs and compile/analyze stability data/reports using istability and JMP and maintain a reference standard and critical reagent programs
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment
Qualifications

What You'll Bring:
  • B.S. degree (with at least 6 years of experience) or an M.S. degree (with at least 4 years of experience) in analytical chemistry or related life sciences discipline. Work experience should include a combination of data management and quality control experience in pharmaceutical product development and/or commercialization.
  • Hands-on experience and/or familiarity with HPLC/UPLC, GC, KF, spectroscopy (UV, FTIR, etc.), dissolution and other common analytical techniques used for small molecule drug substance and solid oral dosage drug product testing.
  • Advanced working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories.
  • Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
  • Ability to work independently with good judgement and strong organization skills
Preferred Qualifications:
  • CDMO management employing cross-functional collaboration skills.
  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is desirable.
  • Small molecule pharmaceutical development for solid oral dosage forms.
  • Experience in a virtual (100% outsourced) biopharmaceutical development business model is preferred
Additional Information

We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
  • Non-accrual paid time off
  • Summer vacation bonus
  • Global, company-wide summer and winter shutdowns
  • An annual lifestyle allowance
  • Monthly cell phone stipend
  • Internal rewards and recognition program
  • Medical, Dental, and Vision Insurance
  • 401(k) retirement plan with company match
  • Life and Supplemental life insurance for family
  • Short and Long Term Disability insurance
  • ESPP offering
  • Health savings account with company contribution
  • Flexible spending account for either health care and/or dependent care.
  • Family planning benefit
  • Generous parental leave
  • [if applicable] Car allowance

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.