Scientist I, Process Analytical Technology

We are seeking a talented and motivated Process Analytic Technology (PAT) Scientist in the Analytic Development Group. This position will have an integral part in PAT method development and in the incorporation of new technologies to provide inline monitoring and process understanding in the development of large molecule (Mab's, Fusion Proteins, Bi-specific antibodies, etc.) products. The target candidate for this role is expected to show strong lab skills, have deep understanding of PAT concepts, have comprehensive data analysis skills and be capable of delivering scientific presentations and writing technical reports.

Job Responsibilities

• Develop and qualify on-line, in-line, and at-line PAT methods.

• Transfer and validate methods and models for real time in-process control.

• Collaborate with Process Engineers and Analytic Scientists to deploy online performance indicators, implement PAT testing and enable enhanced process control strategies.

• Coordinate and participate in cross-functional projects.

• Writing technical protocols and reports ensuring compliance with applicable regulatory guidelines.

Qualifications

• Ph.D. or M.S. in Chemistry, Chemical Engineering, Analytic Chemistry, Biochemistry, Pharmaceutical Science, or related field with 0-3 relevant postdoctoral or industry experience.

• Familiar with FTIR, NIR, Raman, particle size, UV and other measurement techniques that are suitable for PAT applications.

• Demonstrated experience with statistics, chemometrics, programming and data modeling packages such as Matlab, Unscrambler, Eigenvector PLS Toolbox, JMP etc.

• The ability to work successfully in both a team environment as well as independently is essential

• The ability to work in a fast-paced environment, manage priorities, and maintain time lines for multiple projects is essential

• Excellent written and verbal communication skills.

Preferred Experience

• Understanding of cGMPs and ICH guidelines.

• Prior experience with Continuous Manufacturing as well as Batch and Fed-batch manufacturing for Biologic

Other Ideal Personal Characteristics

• Self-motivated with the ability to act with urgency and passion

• Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership

Indeed_Resilience_R100796_Scientist

Posted
10/06/2021
Type
Full time
Salary Range
$58,000.00 - 91,000.00
per Year
Salary range estimated by
Location
Waltham, MA 02254, US
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