Manager, Project Management

1 month ago

Menlo Park, United States CSBio Full time

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

We are seeking a qualified individual to join us as a Project Management Manager at our Menlo Park facility. This position reports to the Direct of Operations. Job responsibilities include the following:

  • Manage timelines for manufacturing-related activities, including product launch, facilities and equipment maintenance, process and method development, and analytical testing schedules.
  • Plan resources and tasks to ensure manufacturing readiness for new and recurring production to meet project timelines.
  • Interface with internal partners (Quality, Manufacturing, Validation, Supply Chain, Facilities and Operations) to ensure successful implementation of continuous improvement initiatives and activities.
  • Liaise with clients and vendors to provide regular project status updates and responses to inquires.
  • Drive project and goal alignments between different departments.
  • Identify and mitigate gaps in the Operations workflow among different departments and lead cross-functional process improvements.
  • Create and maintain project plans, project tracking reports, and Key Performance Indicator reports to drive improvements that achieve operational excellence.
  • Schedule and lead internal and external discussions, and capture meeting notes, action items, and decisions.
  • Communicate project progress and escalate project issues to Management when appropriate.
  • Manage, train, develop, and mentor staff.

Requirements

  • Bachelor’s degree in biotechnology, engineering, or related scientific discipline with 5 to 8 years relevant experience, or Master's degree in related scientific discipline with 3+ years relevant experience
  • 3+ years of project management and technical experience in production or Contract Manufacturing Organization development of pharmaceutical products
  • Excellent communication skills, self-motivated to learn and problem solve
  • Strong GMP knowledge and in-depth understanding of ICH and FDA regulations preferred
  • Able to work effectively and collaboratively in a cross-functional team within a fast-paced environment

Benefits

  • Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
  • Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
  • Disability insurance 50% standard employer paid.
  • 401k 10% 1:1 match
  • PTO policy. 10 days PTO
  • Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
  • Carpool, clean air vehicle, and cell phone reimbursement
  • Employee rewards and recognition program
  • Company organized social events
  • Quarterly sponsored team building activities

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