Manager Chemical Development

Location
Birmingham, AL
Posted
Oct 15, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

JOB SUMMARY:

The Manager of the Chemical Development group will be responsible for process development of internal programs, scale-up and GMP manufacturing of API’s for Phase I-III clinical trials, and identification/synthesis of impurities.  The individual is responsible for assisting with long-term planning and budgeting of the department. In addition, he/she will oversee external drug substance related manufacturing activities conducted on behalf of the company as necessary. He/She is responsible for writing and reviewing regulatory documents (IND, NDA/eCTD), tech-transfer, SOP’s, batch records etc.). The Manager of Chemical Development reports directly to the Director, Chemical 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
  • Oversee planning and production of kilo-scale GMP manufacturing of API’s for supporting initial tox and clinical studies of IND candidates
  • 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
  • Assist in writing chemical process descriptions for IND and NDA applications, CMC documents, SOP’s, batch records and other development and technical reports
  • 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 4-6 years industry experience or MS in synthetic organic chemistry with 5-10 years of industry experience.
  • 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/MS in synthetic organic and process development chemistry  
  • Minimum of 5 years experience in the pharma industry
  • Industry experience 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
  •    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
  • 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 wear protective clothing as required (safety glasses, lab coat) in designated areas

 

 

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.

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.