Job Snapshot
Location:
Cambridge, MA
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Industry:
Healthcare - Health Services
Biotechnology
Pharmaceutical
Education:
Graduate Degree
Experience:
At least 5 year(s)
Contact Information
Description
Primary Role:
This person will lead a small 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:
⢠Lead root cause analysis for process discrepancies and quality investigations with technical nature;
⢠Lead 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.
In addition, this person will provide technical guidance to junior staffs.
Responsibilities:
⢠Group management (10%)
⢠Lead root cause analysis for process discrepancies and quality investigations with technical nature (20%)
⢠Lead data analysis and execution of experiments aimed at reducing recurring deviations, improving process robustness/capacity/productivity, and increasing level of safety and or compliance; (30%)
⢠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%)
⢠Support of regulatory inspection and filings; (5%)
⢠Training of operation technicians. (10%)
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements
Education & Experience Requirements:
This person will have a minimum of : MS degree with 8-12 years or BS degree with 12-16 years professional experience in Biochemistry/Protein Chemistry, Chemical Engineering or related fields.
Hands-on experience with chromatography, filtration, and UF/DF development or manufacturing support.
Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics is a plus.
Prior experience in leading technical staffs and group management is a plus.
Key Skills and Competencies:
This person will have been involved in purification process development or manufacturing support, have technical leadership including the ability to influence, motivate, and drive technical rigor.
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.