BioPharma Consulting JAD Group is seeking a highly skilled Process Development Sr Scientist to join our innovative team.
You will independently design, execute, and advance scientific experiments to support project and organizational goals.
This role serves as a critical technical and scientific resource, often leading projects and providing guidance for innovative approaches to data generation and interpretation.
The position may include overseeing department-wide initiatives and mentoring junior staff.
Responsibilities: Experimentation: Lead the design, execution, and analysis of experiments to investigate new processes and validate results against project expectations.
Data Interpretation: Analyze complex datasets, drawing insights and recommendations that drive project decisions forward.
Process Development: Develop and implement best practices and protocols for process optimization to ensure product robustness and reliability.
Compliance: Ensure all scientific activities adhere to regulatory guidelines, industry standards, and internal quality systems.
Collaboration: Work cross-functionally with various teams to share insights, foster innovation, and ensure alignment with project goals.
Mentorship: Provide guidance and mentorship to junior scientists, fostering a culture of learning and growth.
Documentation: Author high-quality scientific reports, technical documents, regulatory submissions, and patent applications as needed.
Project Leadership: Serve as a key contributor on project teams, influencing decisions on scientific matters and driving initiatives to successful completion.
Skills & Competencies: Excellent analytical and problem-solving skills with a strong foundation in scientific theory.
Proficient in laboratory techniques and principles relevant to process development.
Proficient in Automatic Visual Inspection Machines, technical report preparation, and business/scientific presentations.
Solid knowledge of raw materials, in-process controls, packaging, labeling, and finished product standards.
Experience in technology transfer, pharmaceutical manufacturing, medical devices, biotechnology, and GXP (Good Practice) standards.
Strong communication skills, both verbal and written, including technical writing capabilities.
Proven ability to work collaboratively across departments and influence outcomes.
Strong organizational skills and ability to manage multiple projects simultaneously.
Demonstrated leadership qualities and ability to mentor and develop talent.
In-depth knowledge of cGMP regulations and documentation practices.
Bilingual proficiency in English and Spanish is highly desirable.
Requirements Qualifications: Education: Doctorate degree with 2+ years of scientific experience, or Master's degree with 6+ years of scientific experience, or Bachelor's degree with 8+ years of directly related experience.
Preferred Qualifications: Extensive experience in process development within biopharmaceuticals or related industries.
Experience with process validation, technology transfer, and scale-up methodologies.
Proficient in data analysis software and techniques.
Previous experience leading cross-functional project teams.