Senior Project Manager

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role

As part of the Astellas Gene Therapy (AGT) Research & Technical Operations (RTO) Engineering & Facilities team, the Senior Project Manager is responsible for leading engineering projects, ensuring efficiency and smooth workflow. The Senior Project Manager will provide technical and engineering support to various teams, gather, and analyze data, identify the strengths and weaknesses of existing processes, implement solutions against problem areas, and conduct inspections to ensure that all processes adhere to quality standards and safety requirements and regulations. The Senior Project Manager will monitor the progress of all project resources and train internal and external team members when necessary. This role is expected to possess subject matter expertise in design, construction, and equipment integration and experience in minimizing disruption to operations with effective communication, collaboration, and coordination.

Responsibilities:

  • Be responsible for planning and leading the development, execution, and completion of major strategic capital investment projects or continuous improvement initiatives in close alignment with stakeholders

  • Lead the following project execution activities in collaboration with assigned team members: scope and concept development, Project Execution Plans, basic and detailed engineering, procurement, construction, commissioning and qualification of new facilities or modification of existing facilities or processes

  • Manage safety, regulatory and environmental compliance by conducting design reviews with EH&S representatives, stakeholders, and engineering representatives

  • Educate stakeholders on engineering project execution procedures and processes with emphasis on collaboration, scope delineation, hand-over of responsibilities and compliance

  • Source and contract service providers located throughout the region to augment execution capability, as needed

  • Develop and sustain relationships with multiple service providers (A/E, EPCM, GCs, Automation, Lab Svcs) ensuring cost competitiveness and regional legal requirements

  • Lead projects that optimize RTO effectiveness and efficient operations including IT, automation, and compliance areas of focus.

  • Act in full compliance with corporate and quality policies, GxP requirements, corporate directives, and SOPs

  • Supervise the timely close-out of projects with focus on engineering change management, financial close-out, lessons learned register and vendor score cards

  • Facilitate stakeholder collaborations focused on information sharing, alignment, and promoting engineering best practices

  • Mentor and train other members of the team

  • Improve current guidelines, procedures, tools and templates as part of continues improvement efforts

Required Qualifications:

  • Bachelor's degree in architecture, engineering, construction management. In lieu of degree, 10+yrs equivalent hands-on experience in the field. 8+ years of progressive professional experience, including 5+ years in a project or program management role.

  • In-depth knowledge of engineering, building and site design, construction, operation, and maintenance of laboratory research facilities including BMS/EMS/LIMS systems

  • Broad knowledge of operation and life cycle of life sciences/ biotech research and manufacturing facilities

  • Knowledge of codes, standards, and regulations as they apply to design, construction, operations, and maintenance of buildings and building sites, in particular research facilities and associated BSL design standards

  • Ability to identify issues, analyze and interpret data, and develop innovative solutions to a variety of complex matters of diverse scope and nature

  • Excellent interpersonal skills to collaborate with all levels of employees

  • Ability to represent the company with trade partners, vendors, utility, and service providers

  • Excellent utilization of project management scheduling tools (i.e. Microsoft Project)

  • Excellent analytical, verbal and written communication skills to report and present findings to senior management and external parties

  • This position will be hybrid, with onsite work required at least 3 days per week and will require less than 10% travel.

Preferred:

  • Pharmaceutical/Biological/Biotech industry experience and related equipment, facilities, and maintenance expertise and understanding of industry best practices

  • PMP or equivalent Project Management certification

Salary Range :

  • $129,800-$173,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category Gene Therapy Research & Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans