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Astellas Pharma Project Manager in South San Francisco, California

Are you ready to use your experience and expertise to make an impact on patients’ lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you’d like to be a part of this important mission, please apply to join our team.

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

Reporting to the Associate Director, Facilities, Utilities and Engineering, the Project Manager will be part of the SSF Site Operations Facilities & Engineering department supporting Manufacturing, Laboratories, Warehouse, and administrative facilities. This role is responsible for the successful execution of CAPEX/OPEX/CI projects that meets project goals, timeline and budget. He/she oversees external contractors/vendors to execute projects following site safety, regulatory requirement and quality compliance policies. The role is primarily located in South San Francisco, CA.

Responsibilities

  • Leads internal and external project team to execute projects to meet project goals, timeline and cost.

  • Oversee the entire project lifecycle (project charter, design, plan, execute, commission, startup, validate and project closure)

  • Collaborate with internal end users and support team to establish project charter and determine user requirement specifications

  • Negotiate contracts with external vendors to reach profitable agreements

  • Ensure that permits and licenses from appropriate authorities have been obtained

  • Determine and coordinate needed resources (manpower, equipment and materials) from start to finish with attention to budgetary limitations

  • Plan all construction operations and schedule intermediate phases to ensure deadlines will be met

  • Acquire equipment and material and monitor stocks to timely handle inadequacies

  • Hire contractors and other staff and allocate responsibilities

  • Supervise the work of laborers, mechanics etc. and give them guidance when needed

  • Track and provide project status to project stakeholders and site leadership team

  • Ensure both internal and external project team adhere to all environmental, health and safety standards, regulatory requirement and quality compliance, report and escalate if issue is found.

  • Assumes primary responsibility for activities associated with specific trades on assigned construction sites

  • Promotes positive relationships with internal and external project teams and stakeholders

  • Manages subcontractor and vendor field T&M change requests. Evaluates legitimacy of request in terms of contractual requirements and validity of cost estimate

  • Facilitates communication between subcontractors, vendors, and project personnel, and produces documentation of communication between project participants. Supports the RFI process

  • In concert with EHS Professionals reviews job safety analysis documentation and other safety documentation as required by corporate safety program.

  • Ensure all project document (submittal, SOP/WI, OEM, drawings, TOPs…) are distributed/created, reviewed and archived per site policy.

  • Ensure new equipment installed are properly setup in BMRAM per site assets life cycle management policy (e.g. asset onboarding, PM and calibration setup, establish proper spare parts, P&ID updated…)

Required Qualifications

  • 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

  • In-depth understanding of construction procedures and material and project management principles

  • BSc/BA in engineering, building science or relevant field or equivalent 10+ years experience in the field of facilities, construction, project management and 5+ years experience supervising/ managing individuals

  • Experience in pharma, biotech or similar life science field that are governed by cGMP regulation

  • Proven experience as construction manager and execution of projects from start to finish with In-depth understanding of construction procedures and material and project management principles

  • Good understanding of cGMP operations and handling of qualified systems with knowledge of CMMS, EDMS, and QMS applications.

  • Expert understanding of cGMPs and safety as they relate to the performance of maintenance, repairs, and changes to equipment utilized in the manufacturing process of drug product.

  • Excellent technical writing skills including SOPs, maintenance procedures and routine reports.

  • Expertise interpreting technical documents such as blueprints, schematics, logic flow charts, operating and maintenance manuals.

  • Outstanding communication, negotiation, organizational, and time-management skills

  • Advanced experience with office and project software.

  • A team player with leadership abilities

  • Occasionally required to stand up to 6 hours a day. While performing the duties of this job, the employee is frequently required to reach with hands and arms, stand; walk; talk or hear; and use hands to finger, handle, feel or operate objects, tools, or controls. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl, and lift 50 lbs.

Preferred Qualifications

  • PMP or equivalent certification will be an advantage

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 Gene Therapy Research & Technical Operations

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

EOE including Disability/Protected Veterans

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