Temporary Job - initially for 6 months - Administrative Shift(Monday–Friday, 8:00 AM – 5:00 PM (or standard business hours). Availability to work on weekends as needed. All shifts.)
- Minimum Education:: Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience.
- Preferred Education: A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.
- Minimum Years Experience: Bachelor's degree with 5+ years of relevant scientific experience
- Preferred Additional Experience: In addition to the minimum educational requirements listed below, candidates should have experience with technical data analysis and scientific documentation. Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required. Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
- Recommended Skills Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry. Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support. Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls. Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems. Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization. Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions. Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services. Strong technical writing, communication, presentation, and project management skills. Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement. Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.
We are looking for a Process Development Sr Scientist for the completion of the cycle development and as a technical resource
SUMMARY
To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.
FUNCTIONS
1. Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
2. Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
3. Expands knowledge-seeking beyond core area of expertise
4. Identifies relevant external competitive knowledge
5. Independently prepares new and novel protocols/experimental design
6. Key contributor to an independent research/project team
7. Initiates productive collaborations outside of the department or company
8. Introduces new or advanced technologies and/or concepts
9. May contribute to scientific journal articles or complex technical documents as lead author
10. Leads department-wide support efforts such as safety, recruiting and committees
11. Develops supervisory and mentoring skills
12. Makes proactive decisions that contribute to the achievement of milestones
13. Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.
EDUCATION
-Doctorate PhD OR PharmD OR MD [+ relevant post-doc where applicable] OR -Masters + 3 years of Scientific experience OR -Bachelors + 5 years of Scientific experience.
COMPETENCIES/SKILLS
1. Ability to motivate, lead and/or supervise the activities of others.
2. Ability to develop realistic timelines.
3. Be able to problem solve using the application of scientific theory.
4. Demonstrate skills in independently determining and developing scientific analysis and solutions.
5. Exercise considerable latitude in determining objectives of scientific work.
6. Demonstrate strong laboratory and project management skills.
7. Creative skills in the development of new hypotheses for scientific experiments.
8. Critical evaluation and detailed interpretation of results.
9. Demonstrate knowledge of scientific relevance of targeted work.
10. Bilingual (English and Spanish).
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
#IND2
Job Types: Full-time, Temporary
Education:
Experience:
- statistical software (JMP or Minitab) : 5 years (Preferred)
- Sample Management System such as LIMS and HLEE: 5 years (Preferred)
- sterile drug product manufacturing: 5 years (Preferred)
- aseptic filling operations: 5 years (Preferred)
- process characterization, process validation (PPQ): 5 years (Preferred)
- technology transfer, and commercial process support: 5 years (Preferred)
- validation protocols, characterization studies: 5 years (Preferred)
- technical reports, investigations, and change controls: 5 years (Preferred)
- GMP requirements, aseptic processing principles: 5 years (Preferred)
- tatistical analysis using JMP or Minitab: 5 years (Preferred)
- filling equipment, and sterile manufacturing operations : 5 years (Preferred)
- technical data analysis and scientific documentation: 5 years (Preferred)
- Microsoft Office (Excel, Word, and PowerPoint): 5 years (Preferred)
Language:
Work Location: In person