Process Analytical Engineer, Material Science and Engineering Tech. Drug Product Development - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 8/29/2018

Job Snapshot

Job Description


Description:

  • Our client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science, and contribute to our unique culture. 
  • This position is responsible for establishing Process Analytical Techonology (PAT) methods for process development, characterization, optimization, scale-up, and technology transfer activities of small molecule drug products (DPs) for clinical development of new pharmaceutical products. 

Responsibilities will include, but are not limited to, the following: 

  • Apply process analytical technology (PAT) and material characterization expertise to evaluate the composition, structure, and properties of pharmaceutical systems.
  • Perform data analysis and interpretation. 
  • Evaluate and recommend adoption of new PAT technologies for process characterization, understanding and improvement. 
  • Support PAT method development, validation, transfer and implementation. 
  • Provide technical consultation as needed to product technology, manufacturing, and commercial teams to support new growth programs and production optimization efforts. 
  • Maintain a productive laboratory workspace, which includes managing workflows, processes and systems for the lab, maintaining / troubleshooting equipment, and provide recommendation for continuous improvement. 

Qualifications: 

  • Prerequisite: 
    • Hold a chemical, mechanical, material science, pharmaceutical science degree, or related fields. Ph.D. with 0-2 years, or M.S. with minimum of 4 years, or B.S. with minimum of 6 years of pharmaceutical, chemical or analytical development experience 
  • Skills/Knowledge Required: 
    • Hands-on technical expertise on PAT and Spectroscopy tools (including but not limited to FTIR, NIR, MIR, Raman, etc) with effective instrument operation and maintenance, and strong understanding in: 
      • Statistical, Multivariate and Chemometric data analysis 
      • Material / Pharmaceutical/ Separation Science 
    • Working knowledge of key pharmaceutical unit operations both in drug substance and drug product including, but not limited to, crystallization, mixing, milling, granulation (wet and dry), tablet compression, and coating.
    • Laboratory hands-on experience.
    • Big data interpretation, manuscript preparation, publication and presentation of results. 
    • Experience working in a GMP environment is a plus 
    • Programming experience with Matlab, S-PLUS, SAS and familiarity with commercially available chemometrics packages 
    • Self-motivation, excellent time management, organizational, written and oral communication skills. 


Our client is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. 

Our client complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for our client in the U.S.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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