NPI Manufacturing Lead — New Product Introductions

BioSpace; Thousand Oaks (CA); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

Discretionary annual bonus

Stock-based incentives

Flexible work models

Résumé du poste

Amgen, in Thousand Oaks, seeks a Senior Associate Manufacturing for the New Product Introduction team. You will lead the introduction of new products into the Drug Product facility, coordinating across Manufacturing, PD, QA and Facilities to ensure on-time NPIs and robust documentation.

The role requires strong technical writing, GMP understanding, and project management to drive Change Controls and maintain CDOCS records. Excellent cross-functional collaboration is essential.

Qualifications

• Masters or equivalent in Engineering, Biology, Chemistry, or Life Science.
• Bachelor's with 2 years biotechnology operations experience, or equivalent.
• Associates with 4 years biotechnology operations experience.
• High school diploma / GED with 6 years biotechnology operations experience.

Responsabilités

• Develop, maintain, and implement NPI project plans with cross-functional teams.
• Drive issue resolution and root cause analyses; escalate as needed.
• Articulate problem statements clearly to management.
• Own Change Controls in Trackwise per GMP procedures.
• Own NPI records in CDOCS (Veeva system).
• Lead cross-functional meetings to execute NPIs on schedule.
• Identify improvement opportunities and share Lessons Learned.
• Perform purposeful presence Gemba walks to identify process improvements.
• Report team and plant metrics for visibility.

Connaissances

Project management

Technical writing

Cross-functional collaboration

GMP knowledge

Formation

Masters in Engineering or Life Science

Bachelor’s degree + 2 years biotech ops

Associates degree + 4 years biotech ops

High school diploma + 6 years biotech ops

Description du poste

Amgen, in Thousand Oaks, seeks a Senior Associate Manufacturing for the New Product Introduction team. You will lead the introduction of new products into the Drug Product facility, coordinating across Manufacturing, PD, QA and Facilities to ensure on-time NPIs and robust documentation.

The role requires strong technical writing, GMP understanding, and project management to drive Change Controls and maintain CDOCS records. Excellent cross-functional collaboration is essential.