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.