Director, Small Molecule Analytical Research

2 days ago

Rahway NJ United States Merck Sharp & Dohme Full time

Job Description

The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

As GxP Strategic Lead, you will be part of a team that supports execution of analytical methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for our small molecule portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The role also involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include:

Strategy and Operational Excellence:

  • Driving operational deliverables including timely release of clinical materials by actively partnering with the GxP Analytical teams and other functional areas.
  • Serving as the analytical point of contact for key partner groups, maintaining open and active communication.
  • Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level of compliance and scientific rigor.
  • Proactively identifying and escalating operational risks.
  • Partnering with director-level management to develop and execute operational and enterprise strategies.

Leadership:

  • Representing the team and/or department via presentations to key partner groups or serving as a subject matter expert during GxP audits and inspections.
  • Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships.
  • Serving as a facilitator and mentor to empower others to succeed.

Impact and Influence:

  • Anticipating and solving operational problems that may have broad impact to the business.
  • Planning critical business needs, which can include impact of the external business, regulatory, and compliance environment.
  • Promoting our company's scientific excellence and regulatory influence through leadership in the scientific community.

Qualifications

Education Minimum Requirements:

  • PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.
  • Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.
  • Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.

Required Experience and Skills:

  • A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills.
  • Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.
  • Possess strategic experience in operational control strategy development and execution.
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
  • Demonstrated technical or operational leadership with significant and measurable project impact.
  • Demonstrated ability to develop talent through good mentoring skills.

Preferred Experience and Skills:

  • Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.
  • Project management skills.
  • Established scientific or regulatory reputation supported by publications and/or external presentations.
#J-18808-Ljbffr

  • Head of Small Molecule and ASO Engineering

    2 days ago

    , NC, United States Biogen, Inc. Full time

    Head of Small Molecule and ASO Engineering Full-time Region: US About This Role This key leadership role leads the Biogen Small Molecule and ASO Engineering Technical Authority function, which is accountable for engineering subject matter expertise in small molecule and antisense oligonucleotide (ASO) modalities. Technical Authorities possess a...

  • Associate Director, Small Molecules Business Development

    3 days ago

    Durham, NH, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In...

  • Associate Director, Small Molecules Business Development

    1 month ago

    Newmarket, NH, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In...

  • Associate Director, Small Molecules Business Development

    4 days ago

    Hampton Beach, NH, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In...

  • Director, Regulatory Affairs

    4 weeks ago

    Boston, MA, United States Monte Rosa Therapeutics Full time

    Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible...

  • Director, GRA CMC Small Molecules

    2 days ago

    Boston, MA, United States Takeda Pharmaceuticals Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge....

  • Sr. Director

    1 day ago

    Indiana, PA, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Senior Director/Executive Director Analytical Chemistry

    1 day ago

    Indianapolis, IN, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director, Analytical Development

    2 days ago

    San Diego, CA, United States Treelinebiosciences Full time

    Associate Director, Analytical Development at Treeline Biosciences Any Office About Treeline: Treeline Biosciences is an innovative biotechnology company, founded by an experienced team of biopharmaceutical scientists and executives, committed to developing new medicines against difficult to drug targets in cancer and other life-threatening diseases. We are...

  • Sr. Director

    2 days ago

    Lebanon, IN, United States Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Director - Research & Development - Formulation Research - Large Molecule

    2 days ago

    Indianapolis, IN, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Director, GRA CMC Small Molecules

    1 month ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Director, GRA CMC Small Molecules

    1 month ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Director - Research & Development - Formulation Research - Large Molecule

    2 days ago

    Indianapolis, IN, United States Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Sr. Principal Manufacturing Scientist

    2 days ago

    Lebanon, IN, United States Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Principal Scientist, Analytical Development

    2 days ago

    Cambridge, MA, United States Apex Systems Full time

    Principal Scientist, Analytical Development Location : Cambridge, MA (Onsite)Science: Small Molecule Therapeutics Job Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners. Primary Job Responsibilities: Develop specialized...

  • Director of Institutional Research and Analytics

    1 day ago

    Cambridge, MA, United States Harvard University Full time

    Position Title: Director of Institutional Research and Analytics Req ID: 67449BR School or Unit: University Administration Description: Job Summary The Director of Institutional Research & Analytics will lead the Office of Institutional Research & Analytics (OIRA), a core function of the Office of the Provost that supports Harvard's leadership by...

  • Director Research, Next Generation Psychometrics and Data Science

    2 days ago

    , NJ, United States Society for Learning Analytics Research Full time

    Would you like to work in a highly collaborative professional environment, applying data analysis and statistical programming methods to help answer challenging research questions and support the development of new educational assessments? If this sounds intriguing, then we’d like to talk to you about joining our team of dedicated and innovative research...

  • Associate Principal Scientist, Biologics Analytical Research and Development

    1 day ago

    Rahway, NJ, United States Merck Full time

    Job Description Position Description: Associate Principal Scientist, Biologics Analytical Research and Development (Onsite) The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research facility. ...

  • Quantitative Research Director

    4 weeks ago

    Chicago, IL, United States C+R Research Full time

    ABOUT C+R RESEARCHThere’s a reason we’ve been named one of Chicago’s Best Places to work. For over 60 years, C+R has recognized that our people are our greatest asset. Our culture is built on our employees’ curiosity, allowing everyone to grow and cultivate their passions and strengths, while at the same time, collaborating and supporting one...