Director, Chemical Development

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JOB SUMMARY:
The Director of the Chemical Development group leads a team of scientists comprised primarily of synthetic chemists engaged in process development, scale-up and GMP manufacturing of API’s for Phase I-III clinical trials and commercial launch. The individual is responsible for all long-term planning and budgeting of the department. In addition, he oversees all external drug substance related manufacturing activities conducted on behalf of the company. He is responsible for writing and reviewing regulatory documents (IND, NDA/eCTD), tech-transfer, SOP’s, batch records etc.). The Director of Chemical Development reports directly to the Vice President of Pharmaceutical Development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Demonstrate leadership in process research development and GMP manufacturing of API
  • In-depth knowledge of process chemistry and technical knowledge for development of safe and efficient process
  • Represent Chemical Development on CMC cross-functional sub-teams both within the company and alliance partners
  • Work with project teams and identify project requirements, optimize timelines and develop technical solutions for API process and technology transfer
  • Supervise a team of scientists for process development and implementation of manufacturing routes; from lab-scale to production
  • Develop and implement economically feasible process [Cost of Goods Improvement, (COGs)] routes for drug development programs
  • Oversee planning and production of kilo-scale GMP manufacturing of API’s for supporting initial tox and clinical studies of IND candidates
  • Negotiate contracts with external CRO’s for manufacturing of drug intermediates and API’s globally
  • Implementation of API manufacturing program on global scale for procuring launch quantities
  • Global Supply chain management: identify, evaluate and negotiate contracts and supply agreements globally with raw material and API vendors
  • Ensure cGMP compliance of the facility and direct the maintenance of all equipment in the scale-up laboratory and GMP facility
  • Support Analytical, and Bioanalytical Departments by generating reference standards, identify, isolate and synthesize unknown impurities, labelled API’s and direct efforts in procuring radiolabelled compounds for ADME studies
  • Generate tech transfer packages for external vendors and contractors
  • Ensure that the Chemical Development group’s activities support the overall goals of the company
  • Integrate principles of Quality by Design and Quality Risk Management into process development activities
  • Assist in writing chemical process descriptions for IND and NDA applications, CMC documents, SOP’s, batch records and other development and technical reports
  • Participate in F2F discussions with FDA for guidance on IND and NDA filings
  • Forecast and budget planning for the Chemical Development department
  • Manage employee development including periodic performance reviews and ensure that employees are adequately trained on technical and scientific topics, regulatory and GMP issues, and personal development
  • Recruit high quality chemists to enable the department to handle pre-IND candidates for supporting the company’s drug development portfolio
  • Successfully implement and manage aggressive timelines to deliver on time
  • In-depth knowledge and understanding of US, EU regulations and ICH guidelines
  • Assist in development and communication of department goals and strategies
  • A strong publication and patent record; excellent written, verbal and communication skills; risk taker and result oriented

    REQUIRED EDUCATION/EXPERIENCE/SKILLS:

 

  • Position requires a Ph.D in synthetic organic chemistry with 10-15 years industry experience
  • Atleast 5+ years of supervisory experience as demonstrated with management of  several projects in process development
  • Experience working in the area of process development as demonstrated with relevant peer-reviewed publications, and patents
  • In-depth knowledge of GMP, US and EU regulations and ICH guidelines required
  • Experience in long-term forecast planning and handling departmental budgets

 

Minimal Requirements:

 

  • Ph.D in synthetic organic and process development chemistry  
  • Minimum of 10-15 years experience in the pharma industry
  • Supervisory experience of 5 years in process development
  • Experienced in process development as demonstrated with relevant peer-reviewed publications, and patents
  • In-depth knowledge of GMP, US and EU regulations and ICH guidelines required
  • Represent Chemical Development group on CMC cross-functional sub-teams both within the company and external alliance partners
  • Experienced in long-term planning and handling departmental budgets
  •    Strong leadership qualities, team player and result oriented

     

     Top 3 to 5 Technical Skills:

     

  • Develop and implement economically feasible process routes (COGs) for all drug development programs
  • Supervise global production of API from kilo-scale to commercial GMP manufacturing
  • Optimize project timelines and develop technical solutions for API process and technology transfer
  • Extensive knowledge of US, EU and ICH guidelines; GMP compliance
  • Integrate principles of Quality by Design and Risk Management  

     

    Physical Requirements:

  • Must be able to lift 10 to 15 lbs (tanks, solutions, etc)
  • Must wear protective clothing as required (safety glasses, lab coat) in designated areas
  • Must be able to sit, stand and walk for intermittent periods of time throughout an 8-hour workday

     

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.