Process Development Sr Scientist

Job Description

Job Description

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.

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).

Are there specific educational/software requirements needed?           

• 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.

A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.

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.

What attributes (i.e. - preferred qualifications) would make this candidate stand out?              

• 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 analyse 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.