Associate Director, Manufacturing Package Design

Centessa Pharmaceuticals; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Centessa Pharmaceuticals is seeking an Associate Director, Manufacturing Package Design to lead the design, development, and technical strategy for packaging supporting late-stage clinical and commercial drug product manufacturing.

You will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, and lead packaging programs from development through tech transfer to commercial production.

Qualifications

• Bachelor's degree in packaging eng, mechanical eng, or related field; advanced degree preferred.
• 8–10 years' sponsor-side packaging design experience in late-stage clinical or commercial programs.
• Strong knowledge of cGMP regulations and pharma packaging standards.
• Experience leading packaging strategy and tech transfer to commercial manufacturing.
• Experience managing relationships with CMOs/CPOs and packaging suppliers.
• Demonstrated leadership, cross-functional collaboration, and project management skills.

Responsibilities

• Lead design and technical strategy for primary and secondary packaging for late-stage programs.
• Represent packaging design on cross-functional project teams with CMOs/CPOs.
• Ensure clinical trial packaging and labeling align with production forecasts.
• Direct packaging engineering activities: design verification, validation, stability studies.
• Lead technology transfer from development to commercial manufacturing.
• Develop documentation like design history files and packaging specs per design controls.
• Collaborate with Regulatory Affairs to support regulatory submissions.
• Support packaging readiness for launch and supply continuity.
• Identify opportunities for process improvements in packaging.
• Travel 10–20% as needed.

Skills

Packaging design leadership

Cross-functional collaboration

Project management

CMOs/CPOs management

Regulatory packaging knowledge

Drug substance/product knowledge

CMC packaging authoring

Combination packaging experience

Leadership

Quality issue resolution

Education

Bachelor's degree in packaging engineering

Advanced degree preferred

Job description

Description Of Role

We are currently seeking an Associate Director, Manufacturing Package Design. This individual will lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will provide technical and strategic leadership for packaging systems, ensuring solutions meet quality, regulatory, and commercial manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, as well as external Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to drive packaging design, qualification, and launch readiness for late-stage development programs.

Key Responsibilities

• Lead the design, development, and technical strategy for primary and secondary packaging components/systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters, and blister wallet configurations where applicable) supporting late-stage clinical and commercial manufacturing programs.
• Serve as the manufacturing/CMC packaging design lead representing the company on project teams with external CMOs/CPOs; manage packaging-related technical relationships, including periodic site visits as required.
• Partner with CMC and Clinical Supply Chain to ensure proper clinical trial packaging and labeling are aligned with production forecasts and product demand
• Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations and compatibility studies.
• Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing, including line trials, engineering runs, and scale-up activities.
• Develop and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements.
• Partner with Regulatory Affairs to author and review CMC packaging sections of regulatory submissions and respond to health authority queries related to packaging.
• Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure packaging design supports launch readiness, commercial supply continuity, and product lifecycle management.
• Identify, lead, and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance to achieve sustainable, scalable manufacturing performance.
• Manage packaging-related change controls, deviations, and CAPAs in collaboration with Quality; support root cause investigations related to packaging design or component performance.
• Evaluate and select packaging materials, components, and equipment in partnership with CMOs/CPOs and suppliers; support qualification of new suppliers and packaging lines.
• Provide packaging design expertise in support of the development of quality systems, processes, and procedures.
• Build, lead, and mentor a team supporting manufacturing package design activities (scope dependent on level).
• Provide subject matter expertise and support during regulatory inspections and audits related to packaging design and engineering.
• Domestic and international travel required (approximately 10-20%).

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred.
• 8-10 years’ experience in sponsor-side manufacturing package design, with demonstrated leadership of packaging design programs. Significant experience supporting late-stage clinical and/or commercial packaging programs required.
• Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing.
• Demonstrated experience leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing.
• Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
• Working knowledge of drug substance, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.
• Experience with combination products/device packaging preferred, as applicable.
• Strong leadership, project management, and cross-functional collaboration skills; exercises judgment within broadly defined practices and policies in determining solutions and actions.
• Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success.

Compensation

The annual base salary range for the Associate Director level position is $140,000.00 to $210,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location. In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The (Associate) Director, Manufacturing Package Design role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

EEOC Statement

Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Note

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.