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Senior Associate Scientist

  • Location: East Syracuse
  • Job Type:Contract

Posted 5 days ago

  • Expiry Date: 22 December 2022
  • Referral: 219814@accuick.com

Job Description: 

Comments: This assignment could last as long as 3 years--with the assignment being in 12 month intervals.

The Senior Scientist Person in Plant (PIP) is considered the primary MS&T representative at the external manufacturing facility and works from our Syracuse facility.

This is a Hybrid Role- 50/50(Hybrid)

  • This position is responsible for providing technical support to commercial operations.

  • The position will be responsible for monitoring daily activities at our external manufacturing organization, interfacing with technical, quality and manufacturing representatives at site.

  • This position will support all MS&T related activities at the CMO site and forms part of the MS&T external manufacturing team.

Responsibilities:

  • Responsible for supporting commercial manufacturing performance at the external manufacturing sire.

  • Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.

  • Maintains strong working relationships with external partner(s).

  • Interface with internal functions such as MS&T, Quality, supplier Change Manager and Supply Chain.

  • Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.

  • Tracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.

  • Ensures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.

  •  Ensures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.

  •  Lead/support technology transfer activities as applicable.

  • Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.

Required Experience and Education:

  • Science or engineering degree in biotechnology, biochemical or related discipline.

  • Experience in drug substance manufacturing essential to the role.

  • A strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.

  • Demonstrated ability to work independently and prioritize activities

  • A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential.

  • Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements.

  • Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions Demonstrated ability in technical writing, computer-based knowledge and communication skills.

Top 5 Measurable skills and experiences a candidate must have to be successful in this role:

  •  +5 years of experience with a strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.

  • Demonstrated ability to work independently and prioritize activities

  • A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential

  • Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions

  • Demonstrated ability in technical writing, computer-based knowledge and communication skills.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.