Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job overview

Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed. Might be involved in implementation of Electronic Batch Records.

Discover Impactful Work!

• Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.

• Works on technical/scientific process/product/project activities to implement strategies and technical solutions.

• Creates processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.

• Makes decisions that involve direct application of technical knowledge.

A Day in the Life

• Complete studies, tech transfer, commercial scale-up and support process validation.

• Represent the organization on internal technical discussions.

• Drives problem solving and project results for formulations, equipment and processes.

• Write/revise work orders for existing and new processes, FORMs, reports, memos, and protocols.

• Lead projects with no supervision, implement change control actions, review and plans technical aspects of the project to meet timeline and project goals.

• Support manufacturing operations, change controls, investigations as subject matter expert (SME).

• Collects, interpreters, and summarizes data for statistical analysis.

Keys to Success

Education:

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.

Experience:

• Bachelors and 4+ years of related experience, or, related Master’s degree.

• Experience in a CMO or Pharmaceutical product development field PREFERRED.

Equivalency:

• Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities:

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.

• Detailed knowledge of Good Manufacturing Practices.

• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.

• Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.

• Ability to work on multiple projects simultaneously.

• Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

• Ability to keep current with scientific literature and industry trends relating to process technologies.

• Ability to run technical solutions.

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.