- Provide virtual oversight to contract manufacturers across a diverse range of unit operations to support qualification, supply, and cGMP manufacture.
- Provide technical review of supplier batch records for development/tech transfer and related GMP documentation (e.g., raw material and product specifications, equipment specifications, validation protocols/reports).
- Maintain CQA, in-process, and release data tracking and trending analysis.
- Maintain in-process equipment parameter tracking and trending analyses.
- Provide 'person in plant' oversight to GMP related activities.
- Assist in execution of formalized process risk assessment activities (e.g. FMEA) to support process qualification and regulatory submissions.
- Help oversee CDMO development and qualification activities required to support and launch activities as well as advise on additional early phase program development.
- Support writing and review applicable sections of CMC regulatory filings.
- Author and review relevant Tech Ops SOPs in collaboration with QA.
- Bachelor's, Master's, or Ph.D. in Chemical Engineering with 10-15 years of experience in small molecule pharmaceutical process development and manufacturing.
- Strong understanding of design and development of small molecule drug substance and drug product manufacturing processes from development studies through life cycle management of commercial products.
- Comprehensive knowledge of common manufacturing equipment and technologies as well as chemical plant operations in drug substance and drug product manufacturing.
- Experience in scale-up and manufacturing of drug substance and drug product unit operations.
- Current in cGMPs and how to implement processes which are compliant.
- Proficient in MS Excel, MS Word, SciFinder, MS Project, ChemDraw, JMP or other statistical analysis software as well as reaction modeling software (e.g. Visi-mix, Dynochem) and stability-predicting software (e.g. Slimstat, iStability) preferred.
- Patients - We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
- Accountability - We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
- Transparency - We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
- Honesty and Integrity - Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
- Stewardship - We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
- Lead from where you are - regardless of role or level, we motivate each other to achieve common goals.
- Drive business results - we navigate forward with our eye on the highest priorities.
- Partner and collaborate - we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
- Continuously evolve and improve - we try, we learn, we revise and try again.
- 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
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Director, Commercial Manufacturing - Watertown, United States - Deciphera Pharmaceuticals
Description
Company DescriptionDeciphera 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
We are seeking a Chemical Engineer experienced in small molecule Drug Substance and Drug Product process development and commercial manufacturing to join our Pharmaceutical Development and Manufacturing team. This position will support commercial manufacturing of Ripretinib (QINLOCK) and Vimseltinib and may have input to development and clinical supply of important new medicines. This role will have the opportunity to work with committed and passionate colleagues in a collaborative and team-based culture and with our global CDMO partners.
The ideal candidate will have an BS, MS, or PhD in Chemical Engineering, or related field with experience in manufacturing GMP drug substance and drug product in a virtual environment. The candidate should also have a command of chemical synthesis and purification for small molecule drug substance (active pharmaceutical ingredient) and drug product unit operations.
Specific areas with which the candidate should be familiar with include, but are not limited to, crystallization engineering, batch processes, reaction scale-up, spray drying, blending, and tableting. The candidate should have hands-on experience with development and implementation of controls and processes needed to manufacture under GMP requirements. Familiarity with regulatory writing, quality management and oversight of CDMO activities, and review of batch records and technical reports and qualifications are also important. The successful candidate will be strong in both written and spoken communications, well-organized, and able to thrive in a fast-paced environment.
This position is an on-site position at our Waltham, MA office with up to 25% domestic and international travel required, and will report to the Senior Director, Pharmaceutical Engineering.
What You'll Do:
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.
We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:
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.
