Job Details

Duration: 06 Months contract

Job Description:

• 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.

• They should have a minimum of a bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15+ years preferred). 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. This role requires full onsite presence in New Albany, OH, with occasional extended hours during peak project phases.

Top must have skills:

• Project management

• Smartsheet

• NPI variations

• Change control

Preferred Qualifications:

• Bachelor's degree or higher in Chemistry, Biochemistry, or a related scientific discipline.

• Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing.

• Proficient in analytical laboratory techniques and instrumentation

• Familiarity with laboratory systems such as LIMS and LMES/CIMS.

• Demonstrated understanding of industry regulations, data integrity, and compliance standards.

• Strong technical writing, documentation, and communication skills.

• Experience with method and equipment validation, including verification, transfer, and change control

• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles..

Responsibilities include:

• 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.

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

• Demonstrate the company's Values/Leadership Practices

Basic Qualifications

• Doctorate degree and 3 years of experience OR

• Masters degree and 5 years of experience OR

• Bachelors degree and 7 years of experience OR

• Associates degree and 12 years of experience OR

• High school diploma / GED and 14 years of experience

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.