Deciphera Pharmaceuticals Inc.
Job Title: Senior Manager, Analytical Development & Quality Control
Job Number: 24853
Location: Waltham, MA
Deciphera is seeking a Senior Manager, Analytical Development & Quality Control. This individual will have responsibility for managing pharmaceutical analytical chemistry and GMP 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 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 GMP source documents, oversight of stability operations and reference standard management, and transfer/site implementation of analytical methods to support future supply chain expansion.
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 Senior Director, Analytical Development and MS&T and will be located in the Waltham, MA office.
- Oversee 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/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
- 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 analytical development and quality control.
- Coordinate stability activities at CDMOs and compile/analyze stability data/reports.
- Participate in the selection of analytical CDMOs based upon core capabilities and regulatory compliance.
- Review/approve development reports for data integrity and regulatory compliance; review/approve CMC content incorporated into Module 3 sections of CTD regulatory submissions for translational accuracy.
- Support cGMP audits of CDMO laboratories.
- Maintain effective communication with CDMOs and deliver analytical development and QC objectives in accordance with project timelines and budgets.
- B.S./M.S. degree in analytical chemistry or related life sciences discipline with at least 8 years of analytical development and/or quality control experience in pharmaceutical product development.
- In-depth, working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories.
- In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of NDA and MAA registration.
- Experience in CDMO management and cross-functional collaboration skills.
- Ability to work successfully in a team/matrix environment and independently, as required.
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
- 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.
- Experience in developing and commercializing drugs for oncology and/or orphan diseases is desirable.
- Experience in small molecule pharmaceutical development for solid oral dosage forms is desirable.
- Significant work experience in a virtual (100% outsourced) biopharmaceutical development business model is preferred.