This company is a research-based Bio-pharmaceutical
company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Its goal is
to transform and simplify care for people with life-threatening illnesses around the world. Their therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious
respiratory and cardiovascular conditions. They
have over 10,000 employees and are one of the leading companies in their field.
DUTIES: This position resides in the Packaging Operations organization. The selected candidate will oversee the
Solid Oral Dose packaging operations in the company’s two West Coast locations.
Specific Job Responsibilities:
executes and tracks a variety of packaging projects both internally and in coordination with contract manufacturers.
- Contributes to the development of department strategies.
- Exercises judgment within generally
well-defined procedures and practices to determine appropriate action.
- Normally receives no instruction
on routine work, and general instructions on new assignments.
- Oversees and contributes to
the completion of all technical and operational activities for labeling projects through management of internal and
- Manages complex processes across functions and interacts effectively with the
other team members to ensure product packaging meets regulatory requirements.
- Generates and
maintain Learning Plans and Training Modules. Trains new employees in SOPs and documentation systems.
- Responsible for initiating and directing the implementation of labeling changes and new labeling introductions
on multiple projects across multiple production sites
- Ensures that packaging label copy
and graphics are in accordance with regulatory, industry, and corporate style guidelines.
- Ensures all
packaging documentation (Specifications, Master Production Records, Worksheets, etc.) is completed in a timely and
- Responsibilities ensure the correct and consistent transfer and implementation
of text, graphs, charts, tables, etc. in a clear and accurate manner. Errors, inconsistencies, conflicts, etc.,
require identification and resolution coordinated with appropriate functions.
- Directs activities
within the group to meet company goals including production schedules, budgeting, training, and performance reviews.
QUALIFICATIONS: Requires a Bachelor’s Degree in Packaging, industrial,
mechanical engineering, biomedical engineering or chemical engineering or a related scientific field and a minimum of seven
(7) years of relevant industry experience required.
A Master’s Degree in industrial engineering, mechanical engineering, biomedical
engineering, chemical engineering, package engineering, or a related scientific field and a minimum of five (5) years of
relevant industry experience required. Advanced degree(s) with commensurate industry experience are also considered.
Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
Knowledge and Skills:
- Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory
filing requirements and guidance documents (i.e. SUPAC, PACPAC).
- Demonstrates excellent verbal,
written, and interpersonal communication skills.
- Demonstrates strong computer, organizational, and
project management skills.
- Demonstrates ability to direct and implement technical/electronic solutions for
supporting labeling operations systems (i.e. software, fonts, network issues, inspection systems).