We are currently seeking a Full Time
Associate Director to support our
Quality Control Team. This position is responsible for oversight of QC personnel who conduct in-process and final product testing for Immatics’ GMP products, assay qualifications/validations, and equipment qualifications. Additionally, this position is responsible for working with other departments (e.g., QMS) to perform and approve computer systems validations, and ensuring compliance within the QC department.
Essential functions: - Ensure appropriate staffing of QC department.
- Ensure the QC group functions in a timely, effective manner; and performs in compliance with current regulatory and company expectations.
- Assure effective communication of cGMP testing trends, interpret implications for the site, assist and coordinate implementation of action plans.
- Develop and maintain appropriate metrics to benchmark and track product testing results.
- Act as SME in external audits as necessary.
- Manage product in-process and release testing in accordance with Standard Operating Procedures and Test Methods in compliance with Good Manufacturing Practices.
- Manage the qualification/validation of QC assays and equipment in preparation for further clinical phase development.
Secondary functions: - Review internal audit reports, inspection reports, and nonconformances and develop related corrective action plans.
- Initiate, review and approve relevant controlled documents.
- Analyze data and prepare technical reports summarizing quality control results.
- Initiate and assist with deviation and OOS investigations.
- Assist with department budgeting.
Competencies - Knowledge of flow-based, cell-based, and molecular assays
- Management of QC personnel
- Assay validation
- Knowledge of GMP as it relates to QC
- Ability to multi-task a large number of projects and evaluate priorities with minimal supervision.
- Possess strong verbal, leadership and communication skills, ability to work across functional areas to achieve results.
Work environment: This position works in a typical office and lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Other duties performed while outside of office building could involve exposure to manufacturing operations, along with outdoor conditions and temperatures
Physical demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hear, use hands to finger, grasp, handle, feel or operate objects, tools or controls. The employee is occasionally required to climb, balance, stoop, kneel, crouch, reach with hands
and arms, walk; lift push or pull objects up to 20 pounds. Hand-eye coordination necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Travel required: Occasional travel for external audits and similar may be required (about 10%)
Required education and experience - Bachelor's degree in Scientific discipline
- At least 5 years of personnel management experience
- At least 8 years in a GMP regulated Biologics or Pharmaceutical environment
- Knowledge of GMP regulations
Preferred education and experience :- Master’s degree in Life Sciences discipline
- Experience with molecular assays such as qPCR
- Experience with flow cytometers and tissue culture
Additional eligibility requirements: - Possess knowledge of Quality systems for the Pharmaceutical Industry, cGMPs, and Pharmacopoeia (USP, EP) requirements.
- In-depth knowledge of current expectations and trends of FDA and other regulatory authorities in the areas of cGMPs.
- Understand operations of a pharmaceutical analytical testing laboratory, and manufacturing facility.
- Maintain good working relationships with individuals within the company and external vendors to ensure goals achievements
Work authorization/security clearance requirements Must be eligible to work in the US legally at any time during employment.
Affirmative Action/EEO statement
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”
Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
