Process Development Scientist II - Parenteral Tech Transfer

Comunidade Metodista; Round Lake (IL); On-site; USD 144,000 - 198,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

401(k) plan

Employee Stock Purchase Plan (ESPP)

Paid time off

Job summary

Baxter International Inc. in Round Lake, IL, is seeking a Research Scientist II to lead process development and tech transfer for parenteral products and sterile medical devices.

The role interfaces with global product development teams and requires strong technical leadership in manufacturing processes. Qualified candidates have advanced degrees with extensive experience, working knowledge of GMP/ICH, and the ability to travel.

Qualifications

• BS with at least 10 years, MS with at least 8 years, or PhD with at least 5 years of experience in chemistry, chemical/biomedical engineering or Pharmacy/Pharmaceutical Engineering.
• Experience with parenteral pharmaceutical products and related scientific and practical knowledge.
• Must have working knowledge of GMP and ICH requirements and good understanding of Quality by Design (QbD) principles.
• Ability to work effectively in a matrix organization, and good communication and interpersonal skills are highly desirable.
• Proficiency in languages other than English (French or Spanish) is a plus.
• Must have experience in prioritizing multiple tasks in a fast-paced environment.
• Travel up to 10%.

Responsibilities

• Responsible for selection, evaluation and development of manufacturing processes for parenteral pharmaceutical products and sterile medical devices.
• Participate in multi-disciplinary product development teams to provide manufacturing process input.
• Independently design and conduct process development studies to scale up manufacturing processes for commercial production.
• Conduct technology transfer from R&D to manufacturing facilities and between manufacturing facilities based on sound laboratory/pilot scale studies and thorough understanding of commercial scale processes.
• Design and conduct studies to support regulatory filings or to provide technical justifications for change control.
• Must be able to travel for assignments.

Skills

GMP knowledge

ICH knowledge

QbD principles

Communication skills

French/Spanish language

Task prioritization

Travel readiness

Education

BS in Chemistry or related field

MS in Chemistry / Chemical/Biomedical Engineering / Pharmacy

PhD in related field

Job description

Baxter International Inc. in Round Lake, IL, is seeking a Research Scientist II to lead process development and tech transfer for parenteral products and sterile medical devices.

The role interfaces with global product development teams and requires strong technical leadership in manufacturing processes. Qualified candidates have advanced degrees with extensive experience, working knowledge of GMP/ICH, and the ability to travel.