Packaging Development Engineer

Takeda • Lexington, MA

16h • $135,000 - $206,100 • Hybrid

About The Position

Takeda Development Center Americas, Inc. is seeking a Packaging Development Engineer with the following duties: provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs. Author and review of regulatory information packages and filings/submissions (IND/NDA/BLA). Execute or lead all aspects of a packaging project delivering early phase evaluation to the device sub-team. Deliver on specific performance indicators, including but not limited to (a) successful concept design solutions, (b) visualization of concepts and prototyping as appropriate, (c) successful human factors studies, (d) supporting regulatory submission, and (e) realistic and manufacturable design concepts. Execution Lead for one or more processes, including but not limited to (i) New Product Packaging Technology, (ii) Combination Product and Device Packaging, (iii) Packaging & Art-Work Specifications process including device instructions for use, (v) Packaging Process Development. Execute technical transfer of packaging material and process specifications from development to commercial GMP manufacturing site. Ensures proper level of documentation and covers packaging related aspects in compliance with regulations and cGMP. Technical interface between commercial marketing and R&D for packaging design. Evaluate and resolve technical challenges related to product stability and manufacturing under GMP expectations and requirements. Up to 25% domestic and international travel required for vendor site visits, manufacturing site visits, and technical audits. Up to 40% remote work allowed.

Requirements

• Master’s degree in Packaging Science, Packaging Engineering, or related field, plus 3 years of related experience, OR Bachelor’s degree in Packaging Science, Packaging Engineering, or related field, plus 5 years of related experience.
• Prior experience must include: design, develop and qualify sterile pharmaceutical, medical device and combination product packaging with demonstrated success and commercialization;
• Demonstrate pharmaceutical packaging development knowledge for drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices;
• Utilize cGMP requirements (ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211) and demonstrate application of industry guidance/standards documents (e.g., ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) for combination product submissions;
• Develop and validate packaging testing methods and procedures following ISO 11607 for use in design verification testing;
• Develop and validate packaging testing methods and procedures following compendia testing for CCIT (USP 1207, USP 381/382).

Responsibilities

• Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• Author and review of regulatory information packages and filings/submissions (IND/NDA/BLA).
• Execute or lead all aspects of a packaging project delivering early phase evaluation to the device sub-team.
• Deliver on specific performance indicators, including but not limited to (a) successful concept design solutions, (b) visualization of concepts and prototyping as appropriate, (c) successful human factors studies, (d) supporting regulatory submission, and (e) realistic and manufacturable design concepts.
• Execution Lead for one or more processes, including but not limited to (i) New Product Packaging Technology, (ii) Combination Product and Device Packaging, (iii) Packaging & Art-Work Specifications process including device instructions for use, (v) Packaging Process Development.
• Execute technical transfer of packaging material and process specifications from development to commercial GMP manufacturing site.
• Ensures proper level of documentation and covers packaging related aspects in compliance with regulations and cGMP.
• Technical interface between commercial marketing and R&D for packaging design.
• Evaluate and resolve technical challenges related to product stability and manufacturing under GMP expectations and requirements.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level