Senior Project Manager

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

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

*Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As part of Astellas Gene Therapies (AGT) Center of Excellence Enterprise Engineering & Facilities (EE&F) team, the Senior Project Manager is responsible for leading and overseeing engineering projects, ensuring efficient and smooth workflow. The Senior Project Manager will provide technical and engineering leadership in the delivery of investment projects of varying complexity, and in collaboration with process, automation, facilities, utilities, equipment, and validation subject matter experts as required. The Senior Project Manager will monitor progress of all projects under area of responsibility, mentor, and training junior project managers and engineers, when necessary. This role will report to the Director, Project Engineering and Real Estate and will be based in South San Francisco, CA.

Primary Responsibilities

• Lead the planning, development, execution, and completion of major strategic capital investment projects in close alignment with stakeholders

• Manage project scope, schedule, and budget, provide visibility to status and challenges via project progress reporting, and ensure delivery to agreed targets and requirements

• Ensure effective scope and concept development, establishment of project teams and charters, project execution plans, basic and detailed design and engineering, procurement, construction, commissioning and qualification of new facilities or processes, or modification of existing, and in collaboration with members of the EE&F and site teams

• Drive safety, regulatory and environmental compliance in collaboration with EH&S, stakeholders, and EE&F representatives and adherence to project and asset lifecycle management stage gates

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

• Leverage the lean internal engineering team in execution of engineering projects and augment with external resources from approved service providers throughout the region, or enable remote work where feasible

• Oversee contractors and consultants engaged in project design, implementation, modifications, construction, testing and qualification of facilities & systems, ensuring contracting, training, and vendor qualification processes are adhered

• Ensure compliance with quality policies, Good Manufacturing Practices (GMPs), corporate directives, corporate policies, project execution structure, and Standard Operating Procedures (SOPs)

• Supervise the timely close-out of projects with focus on engineering change management, as-builting, electronic turnover packages, cGMP change control activities, financial close-out, lessons learned register and vendor score cards

• Collaborate with multiple business units including EE&F, TechOps site teams, research, IS, IT/OT, finance, procurement, and legal to manage compliance and timely delivery of projects

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

About you

Must Have/Required

• Bachelor's degree in architecture, engineering, construction management, or a related discipline and 10+ years of progressive professional experience, or technical school certification or diploma in a related technical program, state certified licensing designation, and equivalent experience with 3+ years in a management or program management role

• In-depth knowledge of engineering, building and site design, construction, operation, and maintenance

• Broad knowledge of design and construction methods and processes related to building construction, mechanical infrastructure, and maintenance 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 cGMP

• 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 influence and guide all levels of employees

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

• Excellent utilization of project management scheduling tools (Primavera P6 or Microsoft Project)

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

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

May Have/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

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

Category Engineering & Facilities

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

EOE including Disability/Protected Veterans