Technical Lead CMC Development in Drug Delivery

Employer
Evonik
Location
Birmingham, AL
Posted
Jan 09, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

This position is responsible for leading pharmaceutical formulation research and development activities.  This includes the following:

  • Transferring or optimizing formulations of controlled release parenteral products,
  • Leading pharmaceutical manufacturing process development and design,  
  • Identifying and implementing CMC strategies to accelerate development in an efficient manner from Proof of
  • teams of scientists, engineers, technicians and additional support personnel,
  • Authoring supporting process documentation (Development Reports, Protocols, MBPRs, SOPs,
  • Change Controls, etc.),
  • Contributing to continuous improvement of the formulation development department,
  • Contributing to personnel development
  • Identifying and contributing to the development of intellectual property

The candidate independently determines, develops, and evaluates scientific methods, strategies, and procedures in order to achieve project goals and objectives with consideration to budget and time schedules; . Able to lead multi-faceted research projects including customer communication, technical and resource planning and execution. Is able to lead and support internal innovation projects, knowledge management, and continuous improvement.

RESPONSIBILITIES

  • Advance development programs Other development activities Internal development
  • Follow safety practices and procedures; use personal protection equipment (PPE) appropriate to the type of hazard and exposure potential.  Actively participate in identifying and resolving safety issues.
  • Maintain and increase current scientific knowledge through review of current scientific literature.
  • Capture and formalize knowledge and develop appropriate ways, methods, and tools to do so
  • Systemize and develop organizational and individual knowledge of other related technical skills, methods, and scientific fields.
  • Oversee technical or laboratory activities, as appropriate.
  • Active in seeking out and identifying opportunities related to the maintenance, calibration, and improvement of facilities, equipment, and procedures; takes corrective action independently and/or as directed by management.
  • Prepare research proposals for research projects of varying scope and complexity.
  • Author external publications and presentations.\
  • Propose new opportunities and provide technical support to the development of Intellectual Property.
  • May train and/or oversee other laboratory personnel, as appropriate.
  • Design, conduct, and evaluate results from experiments, studies, and research programs in order to meet project goals and objectives; project activities may range from formulation development, process development and scale up, and/or GLP/GMP manufacturing operations.
  • Lead team in order to conduct projects and develop individuals in project environment
  • Ensure the proper documentation, review, and analysis of experimental activities, observations, data, and results.
  • Lead creation, review and follow SOPs, cGMP, and GLP regulations and procedures; generate and maintain thorough and accurate documentation in support of  cGMP regulated activities.
  • Serve as primary author for research reports and summaries for projects of varying scope and complexity.
  • Interact and communicate effectively with clients on technical aspects of the project (technical lead, technical project management)
  • Guide project teams on regulatory requirements and CMC writing
  • Active in seeking out and identifying opportunities related to process improvement.

REQUIREMENTS

  • A PhD in a relevant scientific field (preferentially pharmaceutical science, biochemistry or associated field); or a MS degree in a related science with a sufficiently demonstrated level of performance and capability, as determined by management.
  • Significant experience in pharmaceutical formulation development and optimization (CMC), especially in late stage development, clinical development and tech transfer projects (more than 5 years preferred)
  • Experience in complex parenteral drug delivery, experience in polymeric microparticles, polymeric or lipid nanoparticles, or liposomes preferred
  • Knowledge of cGMPs, phase appropriate regulatory requirements
  • Experience with lyophilization of parenteral products and lyo cycle development and optimization for sterile manufacturing
  • Experience designing and conducting studies based on statistical Design of Experiments principles following Quality by Design (QbD) standards.
  • Experience leading and executing complex (parenteral preferred) formulation development projects of varying scope.
  • Team leadership and technical project management experience including team building, personnel development, and functional/organizational development and improvement experience.
  • Knowledgeable in several fields across the pharmaceutical product development process, multiple drug delivery technologies

A demonstrated ability to do the following for research activities of an appropriate scope and complexity:

Knowledge of the scientific principles pertaining to, capable in the operation of standard laboratory and/or processing and manufacturing equipment, and able to support the design of custom processing and manufacturing equipment; examples include reactor design, extruder design, pumps, agitators, process instrumentation, data collection, pilot plant operations, etc.

Knowledge of the scientific principles pertaining to and capable of data interpretation of analytical data; examples include HPLC, UV/Vis spectrophotometer, particle size, viscometry, DSC, etc.; capable of conducting statistical analysis of larger data sets e.g. Design of Experiments.

Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals that could potentially affect the health of the employee.

  • Utilize experience, scientific knowledge, and technical creativity as well as development standards to independently determine and develop scientific methods and approaches to meet project goals and objectives and resolve technical challenges; independently manages research tasks of suitable scope and complexity.
    Independently develop, implement, and evaluate new formulations and processes; independently identify and implement new technologies and/or instrumentation of suitable complexity to achieve goals and objectives.