Job Description

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.)

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 necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work.

Discover Impactful Work!

• Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
• Leads technical/scientific process/product/project activities to implement strategies and technical solutions.
• Drives creation of 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.

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A Day in the Life.

• Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.
• Represent the organization on formal technical and scientific forums.
• Lead and/or participate in problem solving and project work for formulations, equipment and processes.
• Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.
• Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points.
• Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.
• Assess material changes and determine change impact.
• Support development of proposals and timelines for projects, leading relevant client meetings.
• Review new bid quotes, protocols, technical documents, results, and reports.

Keys to Success

Education:

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

Experience:

• Bachelors and 3+ years confirmed experience
• CMO or Pharmaceutical product development experience PREFERRED

Equivalency:

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

Knowledge, Skills, Abilities:

• Advanced knowledge of variety of aspects of a subject area and working knowledge of principles and concepts in other relevant technical subject areas.
• 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 leading technical discussions with internal and external clients.
• Ability to work on multiple projects simultaneously.
• Proficiency at developing knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
• Capability to keep current with scientific literature and industry trends relating to process technologies.
• Ability to develop 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.