Senior Advisor, Manufacturing Package Design

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

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Health and wellness program

Job summary

Centessa Pharmaceuticals seeks a Senior Advisor, Manufacturing Package Design to lead the design, development, and strategic packaging efforts for late-stage and commercial drug products. You will guide primary and secondary packaging, drive technology transfer, and manage packaging programs with CMOs/CPOs to ensure launch readiness.

You will partner with CMC, Regulatory, Quality, and Supply Chain to align packaging with forecasts, validation plans, and regulatory submissions.

Qualifications

• 8-10 years’ experience in sponsor-side manufacturing package design with leadership of packaging programs.
• Strong knowledge of cGMP regulations and industry standards for pharmaceutical packaging design.
• Experience leading packaging strategy and design for late-stage/commercial programs, including technology transfer.
• Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
• Working knowledge of drug substance, drug product, and packaging principles 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.
• Strong leadership, project management, and cross-functional collaboration skills.
• Ability to address packaging-related technical or quality issues affecting schedule or supply.

Responsibilities

• Lead design, development, and technical strategy for primary and secondary packaging for late-stage clinical and commercial programs.
• Represent packaging design on project teams with CMOs/CPOs; manage packaging-related relationships and site visits.
• Ensure clinical trial packaging and labeling align with production forecasts and demand.
• Direct packaging engineering activities including verification/validation and stability studies.
• Lead technology transfer from development to commercial manufacturing including line trials and scale-up.
• Maintain design history files, packaging specs, and risk assessments per cGMP and design controls.
• Collaborate with Regulatory to support CMC packaging sections in submissions.
• Support launch readiness and supply continuity across manufacturing, quality, and supply chain teams.
• Identify and implement continuous improvement for packaging processes, equipment, and vendor performance.
• Manage packaging-related change controls, deviations, and CAPAs with Quality; support root-cause investigations.
• Evaluate packaging materials and equipment with CMOs/CPOs; support supplier qualification.
• Provide packaging design expertise for quality systems and procedures.
• Build and mentor a team; support regulatory inspections and audits; travel 10–20%.

Skills

Packaging design

Project leadership

Cross-functional collaboration

CMO management

Technology transfer

Quality systems

Design verification/validation

Education

Bachelor's degree in packaging engineering or related field

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

Description Of Role

We are currently seeking a Senior Advisor, Manufacturing Package Design. The individual in this Associate Director level role 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 Senior Advisor 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 Senior Advisor, 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.