Senior/Executive Director, CGT and Biologics Bioanalysis

2 weeks ago

Exton, United States Pharmaron Full time
Job DescriptionJob Description

Pharmaron is a full-service contract research organization (CRO) developing innovative services and solutions for the pharmaceutical, biotech, medical device, and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device, and cell and gene therapy products. The company's US Lab Services and CGT facilities are strategically located in Philadelphia, San Diego, Germantown, and Boston, servicing hundreds of customers throughout the world. Our facilities are USDA registered, NIH assured, AAALAC accredited, GLP & cGMP compliant, ISO certified, DEA licensed, OLAW assured, and FDA inspected. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company's comprehensive contract services and applied research programs, please visit www.pharmaron.com


Responsible for the overall revenue growth and scientific management of the CGT and Biologics Bioanalytical division for Pharmaron US Lab Services sites. This includes oversight of all activities (R&D to GLP), including project and timeline management, budget, personnel, P&L, and quality control across the three east coast sites of Philadelphia (Exton), Boston (Woburn), and Germantown.

The Senior/Executive Director, CGT and Biologics Bioanalysis acts as a central resource to strengthen BA services across Pharmaron US sites and execute a BA strategy in-line with the initiatives of Pharmaron US Lab Services and CGT.


Roles & Responsibilities

  • Serves as the business owner with direct responsibility for growing the revenues of CGT and Biologics bioanalysis and the service line's gross profit margin.
  • Drives business growth by providing existing and potential new clients with scientific confidence to win studies and ensuring successful project execution through effective team leadership, project management, and compliance with quality standards.
  • Works closely with Executive Management and Bioanalytical teams supporting complementary analytical modalities, Business Development, and Marketing to strengthen the sales of stand-alone and integrated CGT and Biologics BA services.
  • Directs the activities of the technical and project management groups supporting CGT and Biologics Bioanalysis.
  • Establishes strong relationships with internal and external key stakeholders to ensure the timely and successful completion of all projects.
  • Collaborates with Executive Management, Operations, and Business Development for strategic support and resources (e.g., personnel, facilities, equipment, qualified leads/opportunities etc.)
  • Responsible for the sound project and financial management of the group, including preparation of and adherence to budgets and standards for cost measurement.
  • Collaborates with all US sites and related Pharmaron divisions to integrate bioanalytical capabilities with the goal of increasing efficiencies and opportunities with clients.
  • Leads site-specific and integrated (i.e., across site) process improvements in collaboration with local site leadership and Executive Management. This could include strengthening the program management team to facilitate delivery of cross-site projects or developing/strengthening scientific and organizational leadership at any of the CGT and Biologics BA sites to parallel overall growth expectations.
  • Identifies and recommends new capabilities to be added to service offerings based on client interactions, engagement with business development team, literature, and/or competitor review.
  • Serves as a key contact to advance or assist in closing bioanalytical opportunities.
  • Maintains knowledge of emerging technologies and trends to augment Pharmaron's overall CGT and Biologics bioanalytical capabilities.
  • Influences and impacts industry standards and regulations
  • Positions Pharmaron as an industry leader in CGT and Biologics Bioanalysis and participates in strengthening this service line across Pharmaron.
  • Drives external presence through tracking and facilitating conference attendance, including podium and poster presentations, and client interactions.
  • Provides personnel development and mentoring support to Pharmaron scientists to position the organization for future growth.
  • Leverages a strong business acumen to partner with the business development ensuring an improved win rate for bioanalytical opportunities.
  • This position has the responsibility for a staff of 20+.
  • On-site presence: The position requires constant interactions with team members and being available to multi-site team members based on their needs.
  • Travel will be required across the sites that support the Service Line and for other work-related purposes.

Qualifications & Experience

  • Advanced degree in a related scientific field
  • An established track record of leading/enabling horizontal integration
  • Extensive scientific, project delivery, and people management experience.
  • Experience in CGT and Biologics bioanalysis.
  • Experience in budget management and business development.

Knowledge, Skills & Attributes

  • Broad and deep understanding of technology needs and direction in this space to build a world-class/industry leading service line.
  • Proficiency in promoting scientific excellence
  • Strong knowledge of regulations governing bioanalytical testing as mandated by governing bodies.
  • Strong business acumen
  • Strong analytical and problem-solving skills
  • Ability to make timely decisions.
  • Ability to communicate clearly and efficiently (written & verbal)
  • Willingness to take ownership and execute multiple projects.
  • Excellent interpersonal skills with ability to communicate and work with all levels of the organization
  • Ability to influence in a matrixed environment.

Benefits:

Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

  • Medical, Dental & Vision Insurance Plan with Employer Contribution
  • Health Reimbursement Account Funded by Employer
  • Healthcare & Dependent Care Flexible Spending Accounts
  • Employee Life and AD&D Insurance 100% Employer Paid
  • Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
  • Short and Long Term Disability 100% Employer Paid
  • 401k with Employer Match
  • Employee Assistance Program

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.



  • Senior Director, CGT CMC and Analytics

    2 weeks ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionPharmaron is a full-service contract research organization (CRO) developing innovative services and solutions for the pharmaceutical, biotech, medical device, and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device, and cell and gene therapy...

  • Senior Director, CGT CMC and Analytics

    3 weeks ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionPharmaron is a full-service contract research organization (CRO) developing innovative services and solutions for the pharmaceutical, biotech, medical device, and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device, and cell and gene therapy...

  • Scientist

    2 weeks ago

    Exton, United States Frontage Lab Full time

    ABOUT Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file...

  • DMPK Scientist, Bioanalytical

    3 weeks ago

    Exton, United States Frontage Laboratories Full time

    Job DescriptionJob DescriptionABOUTFrontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health...

  • Scientist

    2 weeks ago

    Exton, United States Frontage Laboratories Full time

    ABOUTFrontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND,...

  • Scientist

    2 weeks ago

    Exton, United States Frontage Laboratories Full time

    Job DescriptionJob DescriptionABOUTFrontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health...

  • Associate Project Manager

    3 days ago

    Exton, United States Pharmaron Full time

    Pharmaron (Exton) Lab Services LLC., is a preclinical Contract Research Organization located in Exton, Pennsylvania. Pharmaron provides absorption, distribution, metabolism, excretion, and toxicity (ADMET) testing services to pharmaceutical and biotechnology companies to support drug discovery and development. The Associate Project Manager - Cell & Gene...

  • Associate Project Manager

    4 weeks ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionPharmaron (Exton) Lab Services LLC., is a preclinical Contract Research Organization located in Exton, Pennsylvania. Pharmaron provides absorption, distribution, metabolism, excretion, and toxicity (ADMET) testing services to pharmaceutical and biotechnology companies to support drug discovery and development.The Associate...

  • Senior Research Scientist, Antibody Engineering

    2 weeks ago

    Exton, United States Immunome Inc Full time

    Job title: Senior Research Scientist, Antibody EngineeringLocation: Exton, PAReports To: Senior Director, Antibody EngineeringAbout Us: Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies,...

  • Director of Nursing to Lead a Skilled Nursing

    3 weeks ago

    Exton, United States Connect Senior Care Full time

    **Seeking a strong and energetic Director of Nursing to lead a Skilled Nursing Facility.** **Education**: Graduate of an accredited school of nursing required. Bachelor's degree preferred. **Experience**: Prior experience as Director of Nursing in SNF (2+ years) preferred. **Certificates/Licenses**: (1) Current RN Pennsylvania License in good standing,...

  • Quality Assurance Associate

    1 week ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionPosition Description: The Quality Assurance Associate will be responsible for upholding to quality standards at Pharmaron (Exton) Lab Services, by contributing to all Quality Systems within GMP Operations and reviewing quality data.Primary Responsibilities:Perform client data review and data pack assembly.Serve as primary...

  • Fees & Incentives Analyst II

    1 week ago

    Exton, United States Takeda 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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Senior QC Scientist

    6 days ago

    Exton, United States Beacon Hill Full time

    eneral Responsibilities:Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.Responsibilities:Execute Analytical Test Methods for bulk intermediate testing and final product release testing.Execute testing for...

  • Senior QC Scientist

    20 hours ago

    Exton, United States Beacon Hill Full time

    eneral Responsibilities:Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.Responsibilities:Execute Analytical Test Methods for bulk intermediate testing and final product release testing.Execute testing for...

  • Senior QC Scientist

    1 week ago

    Exton, United States Beacon Hill Full time

    eneral Responsibilities:Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.Responsibilities:Execute Analytical Test Methods for bulk intermediate testing and final product release testing.Execute testing for...

  • GMP Analyst

    2 weeks ago

    Exton, United States Pharmaron Full time

    Are you ready to embark on a journey with a team that's passionate about making a difference? Look no further - Pharmaron is looking for you to join us as our GMP Analyst If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for. This role is based onsite in Exton, PA. What you will...

  • Fees & Incentives Analyst II

    2 weeks ago

    Exton, Pennsylvania, United States Takeda 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'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Instrument Specialist

    2 weeks ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionPharmaron (Exton) is seeking an Instrument Specialist candidate responsible for performing preventative maintenance (PM), routine calibration, performance qualification (PQ), troubleshooting, repair, and inventory of analytical instrumentation and laboratory equipment, including but not limited to HPLC equipment and mass...

  • Associate Director, US IT infrastructure

    3 weeks ago

    Exton, United States Pharmaron Full time

    OVERVIEW We seek a results-focused, innovative, customer-centric well-qualified individual to join our talented team as Associate Director US IT Infrastructure. This role will develop and execute US IT infrastructure strategy including defining blueprint/objectives, building/consolidating IT infrastructure, leading the operational activities (security,...

  • Associate Director, US IT infrastructure

    4 weeks ago

    Exton, United States Pharmaron Full time

    Job DescriptionJob DescriptionOVERVIEWWe seek a results-focused, innovative, customer-centric well-qualified individual to join our talented team as Associate Director US IT Infrastructure. This role will develop and execute US IT infrastructure strategy including defining blueprint/objectives, building/consolidating IT infrastructure, leading the...