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COMPANY:
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: The Senior Packaging Engineer I will focus on the development of
primary, secondary, and tertiary packaging solutions and support of clinical manufacturing operations for oral solid dosage
and parenteral products. They are seeking a motivated, detail oriented individual able to deliver technical leadership in
a cross-functional team setting.
Specific Job
Responsibilities: - Deliver technical leadership in the area of package
development and manufacturing operations, identifying
- solutions to meet stakeholder needs, partnering
with suppliers and contract manufacturing organizations (CMOs), and driving product development.
- Lead packaging
activities in support of multiple clinical programs in all phases of development through commercialization.
- Perform
characterization and qualification of primary packaging components (e.g., bottles, blisters, vials, prefilled
syringe systems).
- Support packaging operations and lead technical aspects of product quality investigations
related to packaging.
- Design and author packaging study protocols and reports on topics such as packaging
equipment and process qualifications, shipping studies, label testing, USP testing, child resistance/senior
friendly testing, etc.
- Author global regulatory content pertinent to packaging.
- Effectively
communicate ideas, project goals, and results to team members across functions and departments.
QUALIFICATIONS: Requires a B.S. Degree in industrial engineering, mechanical engineering, biomedical
engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 5-7 or more 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 highly desirable.
Additional Experience:
- Experience with development and commercialization of packaging for pharmaceutical
products.
- Working knowledge of FDA and cGMP standards for pharmaceutical packaging.
- Experience
with parenteral product components and manufacturing.
- Experience working with pharmaceutical contract
manufacturing organizations (CMOs).
- Self-motivated and organized,
knowledgeable of relevant scientific literature,
- Passionate about scientific
inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving
solutions.
Knowledge & Skills:
- Strong verbal, written, and interpersonal communication skills.
- Must be able
to write clear, concise, and error-free documents.
- Must be able to exercise judgment within well-defined
and established procedures and policies in order to determine and take appropriate action.
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