Jobs
>
Watertown

    Director, Commercial Manufacturing - Watertown, United States - Deciphera Pharmaceuticals

    Deciphera Pharmaceuticals
    Deciphera Pharmaceuticals Watertown, United States

    1 week ago

    Default job background
    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 DescriptionWe 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:


    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.QualificationsBachelor'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.

    Additional InformationWe 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:
    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.

    "How" we work together and the behaviors that we show up with each day are critical to maintaining our positive culture.

    Our behavioral expectations align with our values to elevate and drive individual and team performance:

    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.

    Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

    Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.

    Family planning benefitGenerous parental leave[if applicable] Car allowanceDeciphera (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 INFORMATIONDeciphera 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.



  • Deciphera Pharmaceuticals Watertown, United States

    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 ...


  • HireMinds Watertown, United States

    Senior Director, Process Chemistry & Manufacturing · Watertown, MA · Our client is a mid-sized public company with approved products already on market. Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and l ...


  • HireMinds Watertown, United States

    Our client is a mid-sized public company with approved products already on market. Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produc ...


  • Stratacuity: Proven Scientific Placement Watertown, United States

    Location: Watertown, MA (Onsite) · Science/ Focus: Small molecule therapeutics · Job Overview: The Senior Director will lead chemical process development and manufacturing, serving as a technical expert, coordinating with external partners for drug substance production, and provi ...


  • The Steely Group Waltham, United States

    Our client is looking for an outstanding candidate for a critical position to lead their Manufacturing Science and Technology (MSAT) Organization in support of their growing client portfolio for genomic medicines. This role is responsible for leading and growing a team responsibl ...

  • Thermo Fisher Scientific

    Sr Manager, Finance

    1 week ago


    Thermo Fisher Scientific Waltham, United States Full time

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving co ...


  • 1925 GlaxoSmithKline LLC Waltham, United States Full time

    The Manager for Chemical Development (Engineering) will be responsible for the external development, scale-up, technology transfer and management of robust, cost effective, and safe processes for the manufacture of small molecule and antibody-drug conjugates (ADCs) drug substan ...

  • Priority Search

    Quality Engineer

    1 day ago


    Priority Search Waltham, United States

    We are working on an exciting opportunity to join this Boston area commercial medical device combination product company. Our client uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency which results i ...

  • LASE Innovation Inc.

    Process Engineer

    3 weeks ago


    LASE Innovation Inc. Waltham, United States

    We are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. · LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex b ...


  • Paragonix Technologies, Inc. Waltham, United States

    Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unpreced ...


  • Aurora Innovations Boston, United States

    About RAFI Eltec: · Our company is part of a group that is one of the leading manufacturers of electromechanical and electronic input, display, and control systems with approximately employees. · What do we offer? · A workplace in a modern and growth-oriented company · Flat hiera ...


  • Precision Life Sciences Waltham, United States

    · Job Description: Travel and Expense Analyst · This is a Hybrid role, with onsite days Tuesday - Thursday. · COMPANY OVERVIEW · Company plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) ...


  • ElevateBio Watertown, United States

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...


  • Alkermes Watertown, United States

    Job Description · An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development leadership team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consist ...


  • Apex Systems Watertown, United States Freelance

    Contractor, Process Engineer, Manufacturing Sciences (DS/DP Location: Waltham, MA (Hybrid) Science: Antibody Drug Conjugates TherapeuticArea: Oncology Job Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process valida ...


  • ElevateBio Watertown, United States

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...


  • Alkermes Watertown, United States

    Job Description · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and dete ...


  • Kymera Therapeutics, Inc. Watertown, United States

    Who we are: · Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address ...


  • WiTricity Watertown, United States

    WiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and improve the quality and reliability ...


  • WiTricity Watertown, United States

    Job Description · Job DescriptionWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and im ...