Manager Technical Support

Merck•Indianapolis, IN

4d•Onsite

About The Position

This position is responsible for the day to day management of the Technical Support team in a highly complex pharmaceutical manufacturing facility. This individual will be a working manager expected to provide hands-on technical support as well as leadership of a team of engineering professionals.

Requirements

B.S. in Chemistry, Biology, Engineering, or related discipline required.
Minimum of 5 years of experience in pharmaceutical/biotech operations in technical support, process validation, new product transfer, or similar capacity.
Five years or more management or technical leadership experience or demonstrated skills and experience.
In-depth knowledge of current GMP requirements (US and European), FDA guidelines, and industry standards is required.
Previous experience with direct project oversight including developing and executing equipment qualifications and/or process validations is required.
Working knowledge of process equipment, manufacturing operations, process control systems, process hazards and safety.
Advanced computer skills (spreadsheets, word processing, PowerPoint presentations and databases).
Must thrive in technically and mentally demanding situations.
Strong verbal and written communications skills are required.
Must be well-organized to effectively coordinate multiple projects concurrently.
While performing the duties of this job, the employee is regularly required to use their hands and arms.
The employee is frequently required to stand.
The employee is occasionally required to sit; walk; stoop, kneel, bend, crouch, or crawl, talk or hear.
The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision and peripheral vision.

Nice To Haves

Advanced degree a plus
Strong leadership and sound decision-making.

Responsibilities

Ensure compliance with Corporate and Regulatory Agency policies/regulations throughout all Technical Support operations.
Develop personnel by providing ongoing training, feedback and coaching.
Recruit and hire new employees to meet staffing requirements.
Provide technical leadership and input with respect to new GMP product tech transfer scope definition, estimating, and execution.
Provide direct oversight and coordination of technical personnel supporting GMP manufacturing.
Perform the following as well as schedule, prioritize, and supervise employees for the following activities: Support contract manufacturing business for existing and new clients. Functions include responding to external client requests for contract manufacturing services and execution of special manufacturing assignments.
Coordinate and execute manufacturing projects. Assignments include; project estimating and budgeting, developing Capital Appropriation Requests, scheduling and overall project coordination and oversight.
Individual will be required to coordinate multiple projects of varying scope and size concurrently.
Oversee and conduct deviation investigations and identify/implement corrective actions.
Execute tech transfer projects in support of clinical and commercial products.
Provide manufacturing support for technical projects. Associated tasks include equipment procurement, protocol development and execution.
Oversee and execute creation of Standard Operating Procedures (SOPs), batch records, specifications in support of process changes, installation of new equipment, process validation and new product transfers.
Review/revise raw material specifications in response to supplier changes.
Provide floor support for individual product manufacturing activities.
Lead investigations, review and/or author complex investigation technical memorandums.
Lead and support safety, quality and operability risk reviews.
Supervise and support the manufacturing/technical training and document coordinator.
Create and/or coordinate technical training programs for IMF staff.
Ensure timely completion of quarterly process monitoring reviews and annual product quality reviews.
Provide technical review and approval of manufacturing batch records, raw material and product specification, material evaluation forms, protocols and SOPs.