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Director, Manufacturing Science & Technology

Website Soligenix, Inc.

WHO WE ARE:

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances and clinical execution associated with small and difficult to treat disease indications. Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in direct personal contact with the study sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets. In order to accomplish this, Soligenix has an extremely dedicated, cross-functional team seasoned in the development of rare diseases.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the greatest potential of each of our colleagues.

POSITION SUMMARY:

This successful candidate will be responsible for delivering Biopharmaceutical Development strategies and leading cross functional teams required for the technology transfer, manufacture and release of Company’s growing biopharmaceutical products, primarily focusing on the Company’s near-term commercial product (i.e., a topical hydrophilic ointment for the treatment of a dermatological disease). The Director will principally support the Company’s manufacturing commercialization activities by overseeing the successful completion of chemistry, manufacturing and controls (CMC) deliverables according to rigorous scientific and regulatory standards within agreed upon timelines and budgets. This position will provide committed and accountable leadership for the team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversees commercial manufacturing to support filing of marketing applications and product launch
    • Process and formulation development activities at drug product and API CMO (e.g., Protocol generation, batch record and process execution, manufacturing reports, and data review)
    • Validation activities for processes and analytical procedures
    • Stability protocol, stability monitoring, data review and interim and final reporting
    • Working with CMOs to resolve analytical issues and develop mitigation strategies. Technical review of investigations/deviations which includes root-cause analysis and development of corrective/preventative actions to prevent recurrence of the issue
    • Provides QC review of all GMP data
  • Provides project management oversight of external contract manufacturing and analytical organizations for the accurate and timely creation and dissemination of project milestones, including project costs
  • Provides technical input and leadership to streamline cost effective and compliant processes and analytics during technology transfer and product manufacturing campaigns
  • Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet clinical supply and registration needs, and ensures production, technology transfer, validation and regulatory outcomes, meet and/or exceeds industry standards
  • Communicates effectively and transparently within Biopharmaceutical Development and other stakeholders such as Quality, Regulatory, Clinical and Scientific Affairs across the company
  • Develops Project Plans and timelines, manages and tracks installation tasks and milestones
  • Authors/prepares CMC regulatory documents in support of IND, NDA and BLAs. Authors and manages the generation of all development reports (technology transfer, process development, analytical test methods, qualification and validation reports, interim and final stability reports)
  • Some travel may be required

 

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Minimum of 15 years experience in biopharmaceutical development with MS or PhD in chemistry, chemical engineering, biology or related discipline or a BS with equivalent experience 10-15 years in a leadership role in relevant manufacturing projects and CMO management

EXPERIENCE:

  • 10-15 years of biopharmaceutical experience required in at least 2 of the following areas of product development and manufacturing
    • Development experience (process and analytical development) in biologics manufacturing
    • Vaccine manufacturing
    • Manufacturing of commercial drug products and API
    • Manufacturing experience in semi-solid drug products (e.g., ointments)
  • Comprehensive understanding of drug product development and how biopharmaceutical development activities integrate with contract manufacturers and partner with key functional areas such as Quality, Regulatory, Clinical and Scientific Affairs across the company
  • Demonstrated experience in implementing processes and systems
  • Experience in managing/overseeing CMO
  • Demonstrated expertise in process and analytical development, validation studies and technology transfer of manufacturing processes and analytical methods
  • Experience in being the primary writer for key regulatory submissions including IND, and NDAs (or BLAs)

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

None.

OTHER SKILLS AND ABILITIES:

  • Experience with biological manufacturing processes utilizing coli a plus
  • Demonstrated experience managing multiple projects/CMOs simultaneously with aggressive timelines
  • Experience and demonstrated ability to manage at a high level of productivity with minimal infrastructure
  • Experience in budget planning, management and reconciliation
  • Proficient knowledge of Excel, PowerPoint, Microsoft Project
  • Experience in outsourcing management and oversight
  • Ability to function well in a cohesive management team environment, with strong goal and results orientation
  • Proven verbal and demonstrable written communication skills

How to Apply

Please provide resume, references, and current location via e-mail. Soligenix, Inc. offers a competitive compensation and benefits package. Soligenix, Inc. is an Equal Opportunity Employer. Compensation will be commensurate with experience. No phone calls, please. No recruiters.

To apply for this job email your details to hr@soligenix.com