EmployIndy
  • Immediate Opportunities - Life Sciences
  • Indianapolis, IN, USA
  • Full Time

ATS Manager - NW Indy

EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking an ATS Manager.


POSITION OVERVIEW: This position will manage all aspects of the QC Analytical Technical Services function that supports commercial and investigational products. This includes leading and managing special testing related to QC Lab investigations, analytical method trouble shooting, analytical method optimization and validation, and managing special projects assigned by the head of Quality Operations and management. This position manages a staff of approximately 4-6 analytical chemists, who share equipment / lab space with the commercial QC Chemistry group.

MAJOR RESPONSIBILITIES:
o Supervise the sub-group of QC Chemistry Analysts who are designated as the Analytical Technical Services group. Supervisory responsibilities include:
 Scheduling / assigning projects and project specific tasks to the analysts in the Analytical Technical Services group
 Monitoring the status and progress of the assignments given to each analyst
 Reviewing, commenting, and editing protocols and reports generated by the Analytical Technical Services group
 Ensuring that project and special study deadlines are met by the Analytical Technical Services group
 Developing the technical skills and expertise of the Analytical Technical Services group
 Establishing goals and objectives for each member of the Analytical Technical Services group
 Performing periodic performance reviews for each member of the Analytical Technical Services group and holding each individual accountable for completing their assignments, goals, and objectives
• Serves as proxy and has signature authority for Director, Quality Control when Director, Quality Control is unavailable.
• Provide analytical technical support to with the Director of QC and Manager of QC Chemistry on complex laboratory investigations and analytical method trouble shooting, as needed
• Collaborating with the Manager of QC Microbiology on Technical Services projects that include microbiology lab resources
• Designing special study protocols as needed, managing their execution, and ensuring summary reports are issued in a timely manner
• Managing analytical method optimization and validation for all new analytical chemistry methods, for investigational and commercial drug products and raw materials (including CMO products)
• Responsible for the technical transfer of all CMO
• Notifying the heads of Quality Control, Quality Assurance, and Quality Operations of significant analytical testing issues that may adversely affect the supply of clinical supplies, supply of commercial product, or deadlines for ongoing projects
• Provide input to site wide investigations (NC, Issues, LIR) to ensure compliance with CFR, FDA Guidance, and global regulatory expectations
• Identifying new analytical technologies that can be utilized to improve the analytical controls and CMO products and processes
• Participate in regulatory inspections of the facility (e.g. FDA, MHRA, ANVISA) and customer inspections of the facility

REQUIREMENTS:
• Position requires a Master's Degree in chemistry, biochemistry, or similar life sciences area; Ph.D. is preferred
• Minimum 10 years pharmaceutical laboratory experience required, 5 years at supervisor / manager level
• The position requires proven ability and skill in analyzing, understanding and presenting technical data.
• Extensive knowledge and experience in analytical methodology used for protein and lipid testing required.
• Experience in analytical method validation and method optimization required.
• Extensive experience and knowledge of cGMPs and industry best practices for pharmaceutical laboratory systems
• Experience in technical writing, communicating across organizational levels, and data analysis are required.

 


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