Development Specialist Process Development Commercial Support)

Primary Role:

This person will work with a group of scientists and engineers to provide technical support related to purification processes of commercial products and late stage clinical products of Shire Human Genetic Therapies.

Key actives include the following:

• Support root cause analysis for process discrepancies and quality investigations with technical nature;

• Data analysis and execution of experiments aimed at reducing recurring deviations, improving process robustness/capacity/productivity, and increasing level of safety and or compliance;

• Evaluating new technologies and practices to improve commercial production processes;

• Review GMP documents

• Support technology transfer to support clinical and commercial production;

• Support of regulatory inspection and filings;

• Training of operation technicians. This person will interact extensively with other departments within Shire HGT, including Manufacturing, MTS, PD, QA, Engineering, RA.

Responsibilities:

• Support root cause analysis for process discrepancies and quality investigations with technical nature (30%)

• Data analysis and execution of experiments aimed at reducing recurring deviations, improving process robustness/capacity/productivity, and increasing level of safety and or compliance; (40%)

• Evaluating new technologies and practices to improve commercial production processes; (10%)

• Review GMP documents (5%)

• Support technology transfer to support clinical and commercial production; (10%)

• Training of operation technicians. (5%)

Education & Experience Requirements:

This person will have a minimum of : BS with 0-5 years of professional experience or MS degree with 2-3 years in Biochemistry/Protein Chemistry, Chemical Engineering or related fields

Hands-on experience with chromatography, filtration, and UF/DF development or manufacturing support is a plus.

Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics is a plus.

Key Skills and Competencies:

Candidate will actively participate on multiple cross-functional teams, must demonstrate excellent written and verbal communication skills.

Complexity and Problem Solving:

This person may provide guidance to junior scientists' work, help experimental design, execution and data interpretation.

Internal and External Contacts:

This person will represent the group in support Manufacturing as internal business partner. Close interaction with PD, MFG, MTS, QA, RA and ENG. Externally, they will interact with vendors who may supply materials or equipment used in MFG.

Other Requirements:

Travel may be required for this position both domestic and international.