Manage/Senior Manager, External Manufacturing Site Management

Location
Redwood City, CA
Posted
Dec 06, 2021
Ref
4228163004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Manager / Senior Manager, External Manufacturing Site Management

Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit a Manager / Senior Manager, External Manufacturing Site Management to join our expanding team. The scope of the position and requirements are described below.

Position Summary:

The Manager / Senior Manager, External Manufacturing Site Management would be key member of DS supply team and would be responsible for the project management, financial and supply chain activities related to manufacturing of our late-stage clinical biologics (Mab) molecule AK002 at one of our CMO site. This position would be responsible for the managing project timelines, internal and external meetings, coordinating shipping, update financial spreadsheets for the CMO site.

Your Role:

  • Manage internal and external workflows of SOW’s. Activities include requesting new SoW’s from vendor based on Allakos needs, manage review cycles by distributing SoW’s to appropriate members and collating comments prior to sending it back to vendor in a timely manner. Coordinate approval of the SoW with Legal and Contracts and provide Allakos approved copy back to the vendor for their approvals.
  • Manage external workflow for protocols, reports, and other documents as required.
  • Coordinate with vendors and internal Finance and legal team to drive amendment in contracts and CDA’s.
  • Lead the PM, JPT, JSC, Process and Analytical meetings with the CMO sites. Coordinate with external and internal stakeholders to decide on agenda. Conduct the meeting with the CMO partner to manage time to discuss all outstanding issues. Write or review the meeting minutes and circulate it to the stakeholders.
  • Lead Internal meetings to discuss the site-specific topics. Create the agenda, manage the meeting, and facilitate decision making. Write meeting minutes and communicate it to the stakeholder.
  • Act as representative for the CMO activities in senior management meetings. Communicate issues and recommendations that need to be endorsed.
  • Creating and managing tools for the site:
    • Maintain the overall project plan including the activities with all the stages and SOWs.
    • Send relevant notifications to DS, DP, SC, Finance departments of any changes to the schedule and escalate associated risks.
    • Trackers: Maintain trackers for the following activities
      • CMO activities including Production Batches, studies and other action items.
      • Documents including batch records, protocol, reports.
      • SOWs and Invoices
    • Create dashboards to report metrics on the performance of the site to Senior Management. Dashboards include.
      • Production Batch performance dashboard
      • BLA and other activities dashboard
      • Finance Dashboard
      • Quality Dashboard
      • Timeline dashboard
    • Manage and update the internal Box and SharePoint folder for the project.
    • Shipping:
      • Manage shipping of Drug substance and samples needed for testing between Allakos Supply Chain and vendors at regular intervals. Confirm configuration of shipment. shipping dates and destinations based on need for fill or send to long term storage sites.
      • Fill the appropriate shipping forms and ensure all parties have all appropriate documents.
      • Escalate, trouble shoot and resolve issues as they surface.
      • Coordinate with the shipping company to ship non GMP materials such as samples, consumables and raw materials.
    • Finance:
      • Provide budget for the site at the start of the financial year and update budget spreadsheets in a timely manner with updated SOWs.
      • Create Purchase orders for non-SOW related purchases.
      • Approve invoices for the sites.
      • Quarter closure activities which include providing clarifications on various activities, associated costs, and timelines for the site
      • Site representative for external financial audit

Qualifications and Expertise:

  • BS with at least 8 years of relevant experience successfully working in biopharmaceutical industry.
  • At least 5 years of project management or site management experience for biologics program.
  • Extensive experience in all aspects of project management including working with tools such as Microsoft Project and Smartsheet, creating trackers, dashboards, and other reporting tools.
  • Experience in updating financial documents such as budgets, end of year accounts.
  • Excellent communication skills and business presence to lead and guide meetings to build consensus.
  • Experience in managing international shipping is a plus.
  • Experience working with Contract Manufacturers is preferred.
  • Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.

The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.