Job Details

Payrate: $66.20 - $68.00 /hr.

Summary:
In support of Company's Quality Assurance program, manages and oversees the operations of a specific area(s) of responsibility.
The ideal candidate will be a highly experienced Project Manager with a strong background in biotech or pharmaceutical manufacturing, specifically supporting new product introductions (NPI) and facility expansions.

Responsibilities:

• Leading the NPI's for necessary process, facility, equipment, materials, and training modifications;
• Development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities,
• Change control management,
• Manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities
• Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
• Facilitate the development and optimization of NPI business processes.
• Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI.
• Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications).
• Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

Qualifications:

• Bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15+ years preferred)
• Previous managerial experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources
• The candidate must demonstrate hands-on experience managing end-to-end project schedules, coordinating across cross-functional stakeholders including Process Development, Capital Projects, and Supply Chain.
• Strong knowledge and experience with Smartsheet, NPI variations, and Change Control generation, implementation, and closeout are required.
• Strong communication, organizational, and risk mitigation skills are essential.

Desired Skills:

• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Initiate and lead cross-functional teams
• Collaborate and communicate with higher-level outside resources
• Skill, knowledge, and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development
• Strong communication (both written and oral), facilitation, and presentation skills
• Strong skill in working independently and effectively interacting with various levels
• Ability to lead and influence staff outside own organization
• Ability to motivate staff and manage and distribute workloads
• Able to manage performance issues and conflict
• Ability to provide direction and establish goals for individual staff members and work group
• Ability to evaluate documentation/operations according to company and regulatory guidelines
• Ability to interact with regulatory agencies
• NPI variations
• Change control

Pay Transparency: The typical base pay for this role across the U.S. is: $66.20 - $68.00 /hr. As a non-exempt position, this role will be eligible for overtime, at 1.5 times the base rate, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including medical, dental, and vision benefits, health savings account option for qualified medical plan enrollments, accrual of up to 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, travel reimbursement, accommodations for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement as required by state or local law.

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