Advisor/Sr. Advisor TS/MS (MSAT) β Manufacturing Science & Technology
Key Responsibilities:
- Provide mentorship and scientific expertise for process monitoring, trending, and analysis of production data; support daily manufacturing operations.
- Ensure activities comply with safety and regulatory expectations and cGMP requirements.
- Provide technical representation across the manufacturing network; review/approve annual product review and global product assessments.
- Partner with site leadership to develop and manage technical agendas compliant with regulatory expectations.
- Mentor teams; troubleshoot and resolve technical/operational problems; may lead complex investigations.
- Provide technical oversight with QA/QC to ensure control strategy and ongoing compliance.
- Author technical reports (control strategies, technology transfers, process validation, deviation/adverse event reporting, monitoring/analyses, technical studies).
- Own/assist large process change controls; support regulatory submission strategy and documentation.
- Lead process knowledge transfer and support PAT/data science alignment.
- Design/coordinate lab experiments for troubleshooting/continuous improvement; support start-up/validation and define/control strategies for new products.
Attributes/Skills:
- Technical acumen; technical leadership/mentoring; curiosity and learning agility.
- Self-starter with initiative; data-driven problem-solving.
- Strong interpersonal, verbal/written communication; adaptability in fast-paced environments.
Qualifications:
- PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or related field with relevant experience.
- Required: 3+ years biopharmaceutical industry experience.
- Preferred: 10+ years biopharmaceutical industry experience.
Work Environment:
- 8-hour day shift, onsite; occasional evening/weekend support; occasional travel.
Compensation (anticipated): $129,000β$209,000; may be eligible for company bonus; comprehensive benefits including 401(k), medical/dental/vision, life insurance, time off, and well-being benefits.