Document Specialist, Manufacturing Science and Technology
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
Responsible for the creation and revision of all documents used in GMP Manufacturing. Working in close collaboration with MSAT Senior Document Specialist, Process Sciences, Quality and Manufacturing staff, the person will be responsible for supporting plant manufacturing activities by facilitating timely creation of batch records based on process descriptions, coordinating timelines for document review and approval, and driving for continuous improvement of GMP documents to ensure accuracy and reduce errors.
Key Responsibilities Include:
- Supports creation, editing, and approval of GMP documentation with input from peers, management, and parallel departments.
- Collaborates with MSAT Senior Document Specialist to develop documentation timelines, and drive document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely campaign start dates across multiple campaigns.
• Participates in initiatives for continual improvement of GMP documentation.
- Solicits and incorporates feedback from GMP staff, Process Sciences and Quality groups.
- Develops understanding of GMP operations to design clear instructions enabling error free execution of GMP operations.
- Coordinates and leads training sessions for documentation changes.
- Collaborates with Process Sciences, Quality and other functional areas in the transfer of processes from development to Manufacturing.
- BS/MS in engineering, science, or business management.
- 3+ years of experience in a GMP environment or 1-3 years of relevant GMP documentation experience.
- Proficiency in standard word processing software and project management software is required.
- Demonstrated ability to create and manage work plans and timelines. Must be able to handle multiple tasks and priorities effectively.
- Strong interpersonal skills with a demonstrated ability to collaborate effectively on a cross-functional basis.
- Knowledge of cGMPs with basic understanding of biopharmaceutical unit operations for production of monoclonal antibodies preferred.
- Understanding of regulations that apply to pharmaceutical manufacturing environments. Ability to recognize when practices are deviated from.
- Effective communication and organizational skills.
- Ability to work off-shift and long hours as required
Equal Opportunity Employer Minorities/Women/Veterans/Disabled