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Company

Deciphera Pharmaceuticals · 13 hours ago

Associate Director, Packaging Engineering and Commercial Labeling

Waltham, MA

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

5+ years exp

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BiotechnologyHealth Care

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

SME in packaging and labeling, ensuring proper packaging operations are established for our vendors, packaging specifications and draft labeling specs

Develop, lead, and implement optimal packaging solutions along with ensuring proper testing and analysis to assess the packaging’s performance, including durability, safety and environmental impact, globally.

Work with our commercial label vendor to manage the creation and revision of labeling for product labels globally, packaging materials, and instructions for use that meet medical, legal, and regulatory requirements.

Work with Regulatory Affairs and Quality Assurance on label copy changes and inventory management of packaging material post approval.

Responsible for proper serialization coding, barcoding and GTIN numbers globally, per current regulations and standards.

Develop, establish, and maintain global packaging standards (die lines, process, compliance) leveraging internal and external capabilities.

Manage the specifications, pack specs, change controls, version controls and SOPs related to commercial packaging and labeling.

Manage day to day activities with our commercial packager(s).

Work with MS&T DP on development of new packaging components for late-stage programs.

Assist regulatory team with NDC coding, NDA module writing, draft labeling process and monitoring FDA and global guidelines and requirements for label control.

Lead and manage technical transfers, validations and qualifications of packaging lines, new CPOs or site to site transfers.

Work with the commercial packager to determine appropriate batch size and process improvements.

Set commercial packaging KPIs.

Manage QBR’s etc., and building vendor relationships

Participate in new packaging vendor selection process

Implement validation of the supply chain MRP system in Oracle

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Packaging EngineeringGMP ExperienceFDA RegulationsOracle ERPMicrosoft ExcelSerializationLabeling ApplicationsMicrosoft PowerPointMicrosoft ProjectQuality Management SystemsCollaboration Skills

Required

AD/BA in Engineering (packaging preferred) and equivalent with 5+ years with direct GMP experience

Direct experience in pharmaceutical or device packaging preferred.

Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Packaging and Labeling.

Proficient knowledge packaging and labeling applications, Oracle ERP as well as Microsoft Excel, PowerPoint and Project software required.

Preferred

Understanding of commercial pack out designs and serialization

SME in packaging operations, blisters preferred

High attention to detail and demonstrated ability to manage multiple critical path projects concurrently

Ability to develop, implement and monitor a metrics performance package for labeling and packaging activities

Demonstrated understanding of quality management and documentation systems – especially as related to change control process and product specifications

Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics

Excellent communication and influencing skills, strong collaboration skills

Benefits

Non-accrual paid time off

Summer vacation bonus

Global, company-wide summer and winter shutdowns

An annual lifestyle allowance

Monthly cell phone stipend

Internal rewards and recognition program

Medical, Dental, and Vision Insurance

401(k) retirement plan

Life and Supplemental life insurance for family

Short- and Long-Term Disability Insurance

Health savings account

Flexible spending account for either health care and/or dependent care

Family Planning benefit

Company

Deciphera Pharmaceuticals

Deciphera Pharmaceuticals focuses on improving kinase inhibitor treatments.

Founded in 2003

Waltham, Massachusetts, USA

201-500 employees

http://www.deciphera.com/

H1B Sponsorship

Deciphera Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2022 (5)

2021 (5)

2020 (8)