Commercialization, Development & Optimization Manager

Jubilant HollisterStier CMO; Spokane (WA); Presencial; USD 99.000 - 145.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

FSA/HSA

Life Insurance

AD&D Insurance

Disability benefits

Descripción de la vacante

Jubilant HollisterStier in Spokane, WA, is seeking a CDO Manager to lead commercialization, development and optimization activities. You will plan the CDO portfolio, align resources with business priorities, and manage personnel to deliver work safely, efficiently, and on schedule.

You will establish and improve CDO capabilities, collaborate across sites, and enable technology transfer, validation, and process optimization while ensuring compliance with cGMP and regulatory requirements.

Formación

• Bachelor’s degree in Science required (Biology, Chemistry, Physics, or Engineering).
• 7–10 years in pharmaceutical/biopharmaceutical/CDMO/FDA-regulated industry including development, technology transfer, validation, engineering, commercialization, or manufacturing support.
• Demonstrated people leadership experience (hiring, workload management, coaching, performance management, development).
• Experience managing multiple concurrent cross-functional projects and governance systems.
• Expert in portfolio, resource, and project management.
• Expert in pharmaceutical development, technology transfer, engineering, and validation.
• Expert in technical review and quality oversight of regulated work products.
• Expert in capability development, standardization, and continuous improvement.
• Expert in Microsoft Office and project/portfolio tracking tools.

Responsabilidades

• Plan, prioritize, schedule, and track the CDO portfolio with deliverables, milestones, dependencies, risks, actions, resource needs, and performance metrics; elevate barriers requiring leadership decisions.
• Balance workload and assign resources based on priorities, risk, complexity, team capability, and capacity.
• Lead CDO Validation Engineers, Project Engineers, Formulation and Prep Specialists, and others, including workforce planning, onboarding, coaching, and performance management.
• Build a capable, accountable, collaborative team with clear roles, decision rights, ownership, and performance expectations.
• Develop, implement, and improve CDO development capabilities, standards, procedures, templates, tools, training, and execution systems.
• Review and approve CDO protocols, reports, specifications, assessments, plans, studies, procedures, and other work products for accuracy, completeness, traceability, data integrity, compliance, and readiness.
• Provide technical and project leadership for cross-functional development, engineering, validation, tech transfer, and optimization initiatives with defined requirements and acceptance criteria.
• Coordinate requirements, schedules, risks, decisions, and handoffs with BD, PM, QA, Operations, Engineering, Technical Services, Supply Chain, clients, and site leadership.
• Support new business evaluations by assessing technical feasibility, development needs, resource requirements, risks, schedules, and site fit.
• Ensure CDO activities, systems, procedures, training, and records comply with cGMP, data integrity, regulatory, site, Quality, and client requirements; remain inspection ready.
• Represent CDO in client interactions, governance meetings, inspections, audits, and responses for assigned projects.
• Foster standardization, knowledge sharing, lessons learned, and continuous improvement across projects, functions, and sites.
• Operate autonomously within assigned authority and provide clear recommendations, decisions, and escalation to the Director, CDO.
• Minimal travel (<15%), with occasional off-shift or remote support depending on project needs.

Conocimientos

People leadership

Portfolio management

Project management

Technology transfer

Validation

Regulatory compliance

Quality oversight

Cross-functional collaboration

cGMP knowledge

Microsoft Office

Educación

Bachelor’s of Science (Biology, Chemistry, Physics, or Engineering)

Master’s Degree

Herramientas

Microsoft Office

Project tracking tools

Descripción del empleo

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers — This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well‑being shouldn’t have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here.

Job Description:

The CDO Manager leads the people, priorities, and execution of Commercialization, Development & Optimization activities. The role plans and coordinates the CDO project portfolio, aligns resources and workload with business priorities, and manages CDO personnel to deliver work safely, efficiently, and on schedule.

The Manager establishes and continuously improves CDO capabilities, systems, standards, and ways of working; builds and develops a capable team; and verifies that work products are technically sound, compliant, and fit for purpose. Through effective partnership across functions and sites, the role enables successful development, technology transfer, validation, commercialization, and process optimization.

• Plan, prioritize, schedule, and track the CDO project portfolio, including deliverables, milestones, dependencies, risks, actions, resource needs, and performance metrics; elevate barriers requiring leadership decisions.
• Balance workload and assign resources based on business priorities, project risk, technical complexity, team capability, and available capacity.
• Lead CDO Validation Engineers, Project Engineers, Formulation and Prep Specialists, and other assigned personnel, including workforce planning, hiring, onboarding, goal setting, coaching, training, performance management, succession planning, and employee development.
• Build a capable, accountable, and collaborative team with clear roles, decision rights, ownership, and performance expectations.
• Develop, implement, and continuously improve CDO development capabilities, standards, procedures, templates, tools, training, and execution systems supporting formulation, preparation, process development, technology transfer, validation, commercialization, and optimization.
• Review and approve CDO protocols, reports, specifications, assessments, plans, studies, procedures, and other work products for technical accuracy, completeness, traceability, data integrity, compliance, and readiness for execution or approval.
• Provide technical and project leadership for complex, cross-functional development, engineering, validation, technology transfer, and optimization initiatives, ensuring process requirements, critical parameters and quality attributes, controls, acceptance criteria, and manufacturing readiness are appropriately defined.
• Coordinate requirements, schedules, risks, decisions, and handoffs with Business Development, Program Management, Quality, Operations, Engineering, Technical Services, Supply Chain, clients, and site leadership.
• Support new business and product evaluations by assessing technical feasibility, development needs, resource requirements, risks, schedules, and site fit.
• Ensure CDO activities, systems, procedures, training, and records comply with cGMP, data integrity, regulatory, site, Quality, and client requirements and remain inspection ready.
• Represent CDO in client interactions, governance meetings, inspections, audits, and responses related to assigned projects and deliverables.
• Foster standardization, knowledge sharing, lessons learned, and continuous improvement across projects, functions, and sites.
• Operate autonomously within assigned authority and provide clear recommendations, decisions, and escalation to the Director, CDO.
• Minimal travel (<15%), with occasional off-shift or remote support based on project and operational needs.

Qualifications:

Required:

• A Bachelor’s of Science degree with a major in Biology, Chemistry, Physics, or Engineering is required.
• 7–10 years of relevant pharmaceutical, biopharmaceutical, CDMO, or other FDA-regulated industry experience, including development, technology transfer, validation, engineering, commercialization, or manufacturing support.
• Demonstrated people leadership experience, including hiring, workload management, coaching, performance management, and development of technical professionals.
• Experience managing multiple concurrent, cross-functional projects and implementing project tracking, resource planning, and governance systems.
• Expert in Portfolio, resource, and project management.
• Expert in Pharmaceutical development, technology transfer, engineering, and validation.
• Expert in Technical review and quality oversight of regulated work products.
• Expert in Capability development, standardization, and continuous improvement.
• Expert in Microsoft Office and project/portfolio tracking tools.

Preferred:

• Master’s Degree.
• Statistical Analysis experience.
• Prolonged sitting/standing.
• Exposure to Allergens.
• Working in Aseptic Areas.
• Minimal Travel: <15%.

Shift: Monday-Friday 8:00am-4:30pm

Compensation & Benefits That Start on Day One — Because Your Well Being Matters

Hiring Wage: $98,700 – $144,800 annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.