Job description

Job Description

Title: Associate Director, ATS

Reports to: Director, Quality Control

Department: Quality Operations

Location: Indianapolis

FLSA Status: Exempt

Position Overview:

This position will manage all aspects of the QC Analytical Technical Services function that supports development, early phase, and commercial products. This includes analytical method trouble shooting, analytical method development, optimization, qualification, and validation, and managing special projects assigned by the head of Quality Operations and Exelead management. This position manages a staff of approximately 10-12 analytical scientists, who have a dedicated development laboratory space and share equipment / lab space with the commercial QC Chemistry group.

Major Position Activities & Responsibilities:

• Major Position Activities & Responsibilities: o Manage group of analytical scientists and chemists in the Analytical Technical Services group. Supervisory responsibilities include:

Scheduling / assigning projects and project specific tasks to the scientists in the
Analytical Technical Services group

Working with clients to communicate timelines and develop, qualify, and validate methods

Monitoring the status and progress of the assignments given to each scientist

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.

• Collaborating with the manager of Quality Control regarding scheduling of analytical equipment use
• 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 development, early phase and commercial drug products and raw materials
• Responsible for the technical transfer of all CDMO and Exelead analytical methods
• Provide support for Process Development group, by performing analytical methods that are required for development of new product processes
• 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

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• 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 of

Exelead and CMO products and processes

• Participate in regulatory inspections of the facility (e.g. FDA, MHRA, ANVISA) and customer inspections of the facility

Scope:

• Responsible for managing 10 - 12 analytical scientists, including managing goals, objectives, and performance.
• Responsible for managing Analytical Technical Services annual budget; will have manager level approval authority for purchasing equipment and lab supplies

Background Qualifications:

• 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, nucleic acid and lipid testing required.
• Experience in analytical method validation and method development/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.

Page 2 of 2 JD-10182-00

INDY

6925 Guion Road

Indianapolis

IN

Document Detail 9/30/2022

1

Type: JD

Document No.: JD-10182[00]

Title: Associate Director, ATS Job Description

Owner: DCOLES David Coles

Status: CURRENT

Effective Date: 30-Sep-2022 Expiration Date: 30-Sep-2025

Job Type: Full-time

Pay: From $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay
• Signing bonus

Ability to commute/relocate:

• Indianapolis, IN 46268: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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