Job Description
Duties & Responsibilities:
- Solve complex scientific problems using advanced research and analytical skills.
- Act as an in-house consultant and occasionally as a spokesperson for corporate R&D/technology initiatives.
- Apply scientific expertise to develop company concepts, principles, and innovative solutions.
- Design and execute experiments and approaches for complex problems.
- Synthesize multiple data sources and draw meaningful, non-obvious conclusions.
- Write, review, and approve complex reports, protocols, and documentation.
- Contribute to patent applications and represent the company externally when needed.
- Plan and coordinate projects, ensuring alignment with larger organizational goals.
- Assist in organizational processes, budget planning, and resource identification.
- Lead, mentor, and train junior staff or small groups as needed.
- Ensure compliance with company policies, quality standards, and GMP/FDA regulations.
Education & Experience:
- PhD in a scientific discipline (Biology, Biochemistry, Biotechnology, or related field).
- Equivalent experience may be accepted; exceptional non-PhDs with proven track record considered.
- Strong track record of bioassay development and related scientific contributions.
- Experience in FDA-regulated environments and cGMP practices preferred.
- Prior team leadership or management experience is a plus.
Knowledge, Skills and Abilities:
- Proven success in bioassay development.
- Strong scientific creativity and independent thinking.
- Expertise in applying scientific principles both internally and externally.
- Problem-solving and sound judgment in experimental design and data analysis.
- Excellent communication skills (oral & written) for both technical and non-technical audiences.
- Strong organizational and documentation skills.
- Proficiency with standard tools: MS Word, Excel, PowerPoint.
- Knowledge of lab automation, GMPs, FDA compliance is highly desirable.
Physical / Mental Requirements:
- Recognized subject matter expert in bioassays and bioprocess applications.
- Able to act as a thought leader and influence senior management decisions.
- Collaborative team player with strong interpersonal skills.
- Capable of mentoring others while independently managing complex projects.
- Innovative, detail-oriented, and capable of thinking strategically as well as executing tactically.