Associate Director – Technical Services/Manufacturing Science

Published: December 22, 2022
Location
PR, Puerto Rico
Job Type
Category
Job Code
00448-MFG
Years of Experience
5
Salary
Commensurate with candidate experience.
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

We are searching for an Associate Director eager for a challenging and rewarding new career within a global biopharmaceutical manufacturing company. This is a key role that will lead Technical Services/Manufacturing Science scientific teams on the technical oversight of the manufacturing process. Ensures the reliable and compliant manufacturing of bulk drug substances. This person partners with other roles within the TS/MS organization and other functional disciplines to support the functional and site objectives.  The successful candidate is responsible for:

 

  • Ensures the team has a full understanding of the protein chemistry, control strategy, and manufacturing platform related to the purification process of drug bulk substance.
  • Responsible for the prioritization, execution of routine process monitoring, and manufacturing support that processes remain in control and capable in accordance with regulatory requirements and cGMPs.
  • Develops technical capabilities within the technical staff and performance management.
  • Provides technical leadership for the preparation, review, and approval of technical documents including investigations, change controls, manufacturing tickets, periodic product reviews, process validation, and other technical documents.
  • Acts as the primary technical representative in a cross-functional setting on Flow Team Meetings Deviation Board, etc.
  • Leads the development and execution of process validation, process changes, and implementation of technical projects with the collaboration of the secondary loop and other functions.

Requirements

  • Bachelor’s or master’s or Ph.D. Degree or equivalent in scientific disciplines of Chemistry, Biochemistry, Microbiology, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio/Chemical Engineering.
  • Relevant industrial experience (greater than 5 years) in any of the following disciplines such as: Technical Services, Pharmaceutical Manufacturing, Protein Manufacturing, Quality Control, Quality Assurance, product and/or process development, or Engineering is required.
  • At least 1 year of experience in a supervisory role in the pharmaceutical industry.
  • Knowledge of cGMP, applicable global regulatory manufacturing guidance, and the process/cleaning validation in drug substance pharmaceutical manufacturing.
  • Flexibility is required to support site needs in a 24/7 environment
  • Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.
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