Process Development Sr Scientist

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.

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.