Tech Transfer Engineer in Maryland Heights, MO at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Tech Transfer Engineer!

Summary of Position:

The Technology Transfer Engineer will serve as a key functional core team member and will support and coordinate a smooth technology transfer of processes from initial product conception to cGMP manufacture.

Essential Functions:

  • This individual will interface with research, QC, process development, and manufacturing and will support large R&D projects and project teams through development and implementation of robust processes.
  • Responsibilities include working collaboratively with New Product Development and New Products
  • Initiatives in the process design for new products within existing or new manufacturing equipment.
  • This position may entail preparing documents related to CMC aspects for regulatory submissions.
  • Types of compounds expected are liquids, gases, and solids of radioactive and non-radioactive materials.
  • This role has responsibility for adding additional techniques to their expertise that provide back-up capability for the R&D organization.
  • Oversight, scheduling, planning and reviewing of new process development and tech transfer experiments.
  • Duties include analyzing processes for improved recoveries, through-put and scalability, and utilization of product formulation technologies to establish and optimize new processes for incorporation into product manufacturing.
  • Agile approach and willingness to learn new things.

Requirements:

  • Achievement of a PhD, Master Degree or Bachelor Degree in Chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field with a minimum of 3 years of industry experience required.
  • Pharmaceutical industry experience is required with a strong familiarity with cGMP, FDA, USP, NRC, and ICH guidelines.
  • Radiopharmaceutical experience highly preferred and pharmaceutical development (small / large /biological) experience required.
  • Experience with the full lifecycle for pharmaceutical drug development is highly desired as is a technical understanding of the development process from concept to launch.
  • Ability to manage and prioritize priorities and several projects in parallel to meet deadlines is key.
  • Behavioral requirements for success in this position include: managerial courage, self-starter, strong work ethic, excellent written and verbal communication skills.
  • The successful candidate must have the ability to support and potentially manage multiple technical aspects of projects and contribute to team based investigations.
  • Strong organizational skills, including the ability to work independently and as a team member.

Working Conditions:

  • Candidate must be willing to wear a variety of personal protective equipment.
  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • Must possess good hand-eye coordination.

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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