Executive Director, Structure Characterization

2 months ago

Rahway, United States Merck & Co. Full time

The Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep structural understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch and into supply for extended characterization methods.

 

The Structure Characterization team provides modality agonistic characterization to solve urgent questions arising across the entire pipeline through conformational dynamics and structure elucidation, as well as delivery of structure and quantification of molecules, intermediates, and degradation products to identify potential CQAs. The team also establishes structural understanding through high resolution Mass Spectrometry and NMR characterization across modalities to build mechanistic understanding to enable insights in structure-function and molecular interactions with excipients.

 

The Executive Director reports to the Associate Vice President, Analytical Enabling Capabilities and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-60 people across our Boston, MA, Rahway, NJ, South San Francisco, CA, and West Point, PA sites. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from discovery into supply. 

 

The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. The Executive Director would be accountable for the growth/career development and performance of their team with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team, and implement and manage change to enable process improvement and optimal workflows. 

 

Responsibilities include, but are not limited to, the following:

Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Enabling Capabilities with delivery of high-resolution Mass Spectrometry and NMR characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel methodology and processes to position Analytical Enabling Capabilities to deliver against future pipeline needs.   

Quality and Regulatory Standards: Develops and implements phase appropriate methods for structure and quantification of molecules, intermediates, and degradation products when required. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

Project Management and Teamwork: Responsible for managing quality and timelines for development projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary.  Ensures the department works as a partner with collaborators and teams.

Building Teams & Talent: Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives.  

Communications:  Maintains productive communications with staff, colleagues across Discovery and CMC development as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. 

 

Education:

MS in relevant scientific discipline with 15+ years’ experience or PhD in relevant scientific discipline with 12+ years’ experience

 

Required Experience and Skills:

12 + years of biopharmaceutical development experience.

Subject matter expertise in structure elucidation.

Demonstrated ability in leading large teams and mentoring and developing talent.  

Incumbent must have excellent interpersonal, communication, and collaboration skills.

Strength in delivering results on firm deadlines in support of drug/vaccine development.

 

Preferred Experience and Skills:

Broad external network with experience advancing the field of enhanced structure elucidation capabilities.

  • Associate Director Oncology Marketing

    3 months ago

    Rahway, New Jersey, United States Merk Full time

    Job Requirements This posting has been created to build a talent pool for potential positions that we anticipate will be required in the near future within our organization. By applying to this Pipeline Advertisement, you will be expressing your interest in being contacted for roles similar to those described in the Pipeline Advertisement.As a strategic...

  • Associate Director Oncology Marketing

    3 months ago

    Rahway, United States Merk Full time

    Job Requirements This posting has been created to build a talent pool for potential positions that we anticipate will be required in the near future within our organization. By applying to this Pipeline Advertisement, you will be expressing your interest in being contacted for roles similar to those described in the Pipeline Advertisement.As a strategic...

  • Senior Principal Scientist/Senior Director, Precision Bioinformatics

    1 week ago

    Rahway, United States MSD Malaysia Full time

    Senior Principal Scientist/Senior Director, Precision Bioinformatics Job DescriptionThe Precision Genetics group within the Data and Genome Sciences Department is recruiting a Sr. Principal Scientist, Precision Bioinformatics site lead for our San Diego based Companion Diagnostics (CDx) efforts. We are seeking an experienced computational biologist with a...

  • Vice President of Administrative Operations

    1 week ago

    Rahway, New Jersey, United States RWJBarnabas Health Full time

    Chief Administrative Officer - RWJBarnabas HealthOverview:The Chief Administrative Officer (CAO) at RWJBarnabas Health will be responsible for formulating, implementing, and steering the strategic and operational framework of the organization, ensuring alignment with overarching goals while addressing the needs of the community and patient population.The CAO...

  • Quality Assurance Analyst

    1 week ago

    Rahway, New Jersey, United States AA2IT Full time

    Job OverviewWe are seeking a dedicated Quality Assurance Analyst to join our team. This role is essential in ensuring the highest standards of quality in our products and services.Key Responsibilities:Manage and oversee deviations and customer complaints, ensuring thorough investigation and resolution.Coordinate with external manufacturing sites regarding...

  • Project Manager for Business Solutions

    7 days ago

    Rahway, New Jersey, United States Eshy Inc Full time

    Job OverviewEshy Inc is seeking a proficient Business Project Manager with extensive experience in Appian BPM and database management. The ideal candidate will have a strong background in designing, developing, and implementing business process management solutions utilizing the Appian platform.Key Responsibilities:Guide and mentor fellow Appian developers...

  • Early Development Lead Clinical Data Manager

    3 days ago

    rahway, United States Parexel Full time

    Parexel is looking for an Early Development Lead Clinical Data Manager! This is a Hybrid Role- Candidates need to be located near West Point, PA or Rahway, NJ Early Development Lead Clinical Data Manager- Job DescriptionDescription of Role & ResponsibilitiesUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible...

  • Early Development Lead Clinical Data Manager

    3 weeks ago

    Rahway, United States Parexel Full time

    Parexel is looking for an Early Development Lead Clinical Data Manager! This is a Hybrid Role- Candidates need to be located near West Point, PA or Rahway, NJ Early Development Lead Clinical Data Manager- Job DescriptionDescription of Role & ResponsibilitiesUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible...

  • Early Development Lead Clinical Data Manager

    3 days ago

    rahway, United States Parexel Full time

    Parexel is looking for an Early Development Lead Clinical Data Manager! This is a Hybrid Role- Candidates need to be located near West Point, PA or Rahway, NJ Early Development Lead Clinical Data Manager- Job DescriptionDescription of Role & ResponsibilitiesUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible...

  • Early Development Lead Clinical Data Manager

    3 weeks ago

    Rahway, United States Parexel Full time

    Parexel is looking for an Early Development Lead Clinical Data Manager! This is a Hybrid Role- Candidates need to be located near West Point, PA or Rahway, NJ Early Development Lead Clinical Data Manager- Job DescriptionDescription of Role & ResponsibilitiesUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible...

  • Senior Specialist, Audit

    3 months ago

    Rahway, United States Merk Full time

    Job Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed in the future for our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.Expand your skills and experience in...

  • Facilities Maintenance Lead

    1 week ago

    Rahway, New Jersey, United States JCM Living Full time

    Job OverviewAbout JCMLivingBecome a part of JCMLiving and advance your career within our vibrant communities. We offer a competitive salary along with a comprehensive benefits package, all backed by our experienced management team. At JCMLiving, we prioritize both personal and professional development, ensuring equal opportunities for all employees to...

  • Medical Project Manager

    1 month ago

    Rahway, United States AllSTEM Connections Full time

    AllSTEM Connections is currently hiring for Project Manager for one of our pharmaceutical companies.Contract: 12 MonthsLocation: Rahway, NJ (Hybrid)Pay rate: $58/hrAdditional: Pharma or Biotech industry background. This is not an IT Project Management role. Qualifications:Bachelor’s or master's degree in a scientific, business, or related healthcare area...

  • Senior Operations Specialist

    4 weeks ago

    Rahway, United States MSD Malaysia Full time

    Senior Operations Specialist - Facilities and Project Lead Job Description The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future. The Building 50...

  • Oncology Portfolio Project Manager

    4 weeks ago

    Rahway, United States NavitsPartners Full time

    Job DescriptionJob DescriptionJob Title: Oncology Portfolio Project ManagerLocation: Rahway, NJ 07065Duration: 12 MonthsJob Description:Ensure robust engagement among global, regional, and local markets on Oncology New Product.Monitor and update GRL approach: Track and provide visibility (next 1-2 years) of evolving Pan, Early, Launch global commercial team...

  • Operations Expert

    1 week ago

    Rahway, New Jersey, United States MSD Malaysia Full time

    Senior Operations Specialist - Facilities and Project Lead Job DescriptionThe West Point campus is a significant vaccine manufacturing site with a large workforce. This facility is dedicated to producing bulk and final dosage forms for a variety of vaccine products and is expanding to meet future demands.The Project team for the Live Virus Vaccine Filling...

  • Lead Operations Specialist

    1 week ago

    Rahway, New Jersey, United States MSD Malaysia Full time

    Senior Operations Specialist - Facilities and Project ManagementThe West Point campus is a key manufacturing site for our company, focusing on vaccine production with a workforce exceeding 2000 employees.This facility is dedicated to the production of both bulk and final dosage forms for our vaccine offerings and is expanding to meet future demands.The...

  • Sr. Scheduler

    3 months ago

    Rahway, United States Currie & Brown Full time

    About The RoleCurrie & Brown is one of the leading International physical asset management and construction consultancies, dedicated to advising clients worldwide with our expertise and experience in multiple sectors and services. We are differentiated by our people, innovation and reputation with a genuine global office network.Our people, from the...

  • Sr. Scheduler

    3 months ago

    Rahway, United States Currie & Brown Full time

    About The RoleCurrie & Brown is one of the leading International physical asset management and construction consultancies, dedicated to advising clients worldwide with our expertise and experience in multiple sectors and services. We are differentiated by our people, innovation and reputation with a genuine global office network.Our people, from the...

  • Senior Manager, Communications

    4 weeks ago

    Rahway, United States Sodexo Full time

    Unit Description: We are the Communities we serve! This account is part of the SodexoMAGIC portfolio of business. Use your passion for service to create a positive impact and make a difference in the communities we serve! SodexoMAGIC is a joint Sodexo/ Magic Johnson venture. SodexoMAGIC promises to empower the communities we serve by offering best-in-class...