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Hovione

Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

To reinforce our team we are looking to fill the following position at our New Jersey site:



CMC Principal  (NJ)

The Product Development and Licensing (PDL) group is a relatively new business unit of Hovione and is responsible for the successful execution of Hovione’s proprietary Drug Product development programs, from pharmaceutical development to mid-stage clinical development. Our efforts have led to two clinical stage programs: we just completed a Phase 1 study in blepharitis patients and initiated a Phase 2b study in rosacea patients. Current therapeutic areas of interest include ophthalmology, dermatology, and inhalation.br>

PDL is looking for a CMC Principal to join its multidisciplinary team. The position will be responsible for managing and executing all CMC related activities from pharmaceutical development through Drug Product manufacturing to support preclinical and clinical development of its programs. The candidate will work cross-functionally with internal teams and external CROs/CMOs for pharmaceutical development and drug product manufacturing. This role will be instrumental in progressing programs from concept to preclinical and to clinical stages; it also will be responsible for managing Drug Product manufacturing with appropriate quality standards on time, in scope and within budget, to support clinical Phase 2 and Phase 3 studies.

Main responsibilities:

  • Lead and coordinate all CMC-related tasks for PDL programs;
  • Evaluate CROs and CMOs for pharmaceutical development and for manufacture of drug products identified by the PDL;
  • Prepare scope of CMC work required to support drug product supplies for nonclinical and clinical studies;
  • Work with internal and external partners to set regulatory compliance requirements for validation of analytical methods and processes;
  • Maintain and update project schedules, motivate and influence internal and external teams to provide the highest level of execution in completing tasks, meeting benchmarks and established timelines;
  • Develop pharmaceutical development plans for new programs in PDL's therapeutic areas of interest and help prepare all CMC-related documents required for regulatory submissions;
  • Manage CMOs for the manufacture of drug products, ensuring clinical stage appropriate quality and validation standards, as required by the regulatory agencies;
  • Manage global cross-functional teams and external CROs for drug product manufacturing and pharmaceutical development;
  • Plan, budget and monitor all CMC-related aspects of the preclinical and clinical-stage programs;
  • Develop, track, and execute CMC goals and objectives of the development programs;
  • Identify and communicate potential risks with the CMC and develop mitigation strategies;

Profile:

  • Education: BS or Ph.D. in pharmaceutical sciences or related areas;
  • Minimum 5 years of successful experience in pharmaceutical development and drug product manufacturing, preferably for ophthalmic/inhalation routes of administration;
  • 5 years of successful experience in working with CMOs for drug product manufacturing and analytical methods technology transfer, including setting specifications and validation requirements;
  • Experience in creating and actively managing integrated timelines and budgets for all CMC related aspects of drug development programs;
  • Prior experience managing budgets and CROs/CMOs;
  • Familiarity with sterile drug product manufacture;
  • Strong analytical and pharmaceutical development skills, as evidenced by successfully progressing programs from discovery through clinical development;
  • Collaborator and influencer;
  • Proven record of accomplishments in pharmaceutical development and drug product manufacturing;
  • Thorough understanding of the pharmaceutical development processes and regulatory requirements for different stages of preclinical and clinical development;
  • Ability to perform in a fast-paced environment with competing priorities under demanding timelines;
  • Ability to effectively manage diverse cross-functional teams in a matrixed organization;
  • Strong written and verbal communication skills;
  • Ability to travel both domestically and internationally
         

We offer:

  • Competitve salary and benefits commensurate with the job function and candidate’s relevant experience ;
  • Excellent work environment, with a strong focus on quality.