Senior Director, Drug Product Commercial Manufacturing
Apply NowCompany: Deciphera Pharmaceuticals, Inc.
Location: Waltham, MA 02453
Description:
Company Description
Job Description
We are seeking a Chemical Engineer experienced in small-molecule Drug Product process development and commercial manufacturing. The candidate will support the commercial manufacturing of QINLOCK and ROMVIMZA, and provide input to the development and clinical supply of new medicines. This role involves working with global CDMO partners and requires hands-on experience with GMP drug products, regulatory writing, quality management, and oversight of CDMO activities.
Key Responsibilities:
Qualifications
Additional Information
Benefits:
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 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.
Job Description
We are seeking a Chemical Engineer experienced in small-molecule Drug Product process development and commercial manufacturing. The candidate will support the commercial manufacturing of QINLOCK and ROMVIMZA, and provide input to the development and clinical supply of new medicines. This role involves working with global CDMO partners and requires hands-on experience with GMP drug products, regulatory writing, quality management, and oversight of CDMO activities.
Key Responsibilities:
- Oversee CDMOs to support qualification, supply, cGMP manufacture, and lifecycle management activities.
- Develop and maintain strong relationships with CDMO business partners.
- Lead process tech-transfers and PPQs to support supply chain expansion and continuous improvement initiatives.
- Review GMP documentation and support investigations and CAPA implementation.
- Author and review technical reports and SOPs in collaboration with QA.
Qualifications
- Bachelor's/Master's plus 15+ years of experience.
- Prior technical leadership roles in small-molecule pharmaceutical drug product development and commercial manufacturing.
- Expertise in scale-up and tech-transfer of drug product manufacturing processes.
- Strong vendor/supplier management and cross-functional collaboration skills.
- Ability to travel (30%) to CDMO's domestic and international sites.
Additional Information
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 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.