Immatics NV
Senior Operational Quality Assurance Specialist - 2nd Shift (1012)
Immatics NV, Houston, Texas, United States, 77246
FLSA Classification : Exempt/Salary
Schedule:
Monday - Friday; 1400 - 2230; On-Site (Eligible for one day of WFH per week after the successful completion of the 90-day probationary period).
Department:
Global Quality Operations
Reports to:
Operational Quality Assurance Manager
Supervisory responsibilities:
No
Location:
13203 Murphy Road Suite 100 Stafford, TX 77477
Position Summary/objective:
The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release.
Essential functions:
Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations.Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assuranceCompetencies:
Ability to make sound decisions and approach problems with curiosity and open-mindednessHigh degree of independent working, analytical reasoning, and the ability to communicate effectivelyCareful editing and documenting of resultsAbility to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellenceAbility to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skillsAbility to effectively collaborate with members from other departments
Work environment:
This is a sedentary position (at least 50% of time) in a typical office environment and/or clinical lab environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.
Physical demands:
Communicating Verbally
- expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.Hearing
- the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.Keyboarding
- entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.Lifting
- raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.Near Visual Acuity
- clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).Pushing
- Exerting force upon an object so that the object moves away from the object.Pulling
- Exerting force upon an object so that the object moves toward the force.Sitting
- remaining in a sitting position for at least 50% of the time.Standing/Walking
- remain on one's feet in an upright position at a workstation.Stooping
- occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Required education and experience:
The job title will be determined based on the candidate's qualifications and years of experience.Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field. A higher degree is preferred.Extensive experience (4+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch releaseAt least 4+ years of Biotechnology and/or pharmaceutical industry experience is required.Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.Familiarity with relevant standards, such as cGMP (current Good Manufacturing Practice) and GCP (Good Clinical Practice).In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams and interact with regulatory agencies.Strong attention to detail, problem-solving abilities, and the ability to prioritize and manage multiple tasks simultaneously.Proactive mindset and a commitment to continuous improvement in quality assurance processes and practices.
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for 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. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.
Schedule:
Monday - Friday; 1400 - 2230; On-Site (Eligible for one day of WFH per week after the successful completion of the 90-day probationary period).
Department:
Global Quality Operations
Reports to:
Operational Quality Assurance Manager
Supervisory responsibilities:
No
Location:
13203 Murphy Road Suite 100 Stafford, TX 77477
Position Summary/objective:
The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release.
Essential functions:
Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations.Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assuranceCompetencies:
Ability to make sound decisions and approach problems with curiosity and open-mindednessHigh degree of independent working, analytical reasoning, and the ability to communicate effectivelyCareful editing and documenting of resultsAbility to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellenceAbility to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skillsAbility to effectively collaborate with members from other departments
Work environment:
This is a sedentary position (at least 50% of time) in a typical office environment and/or clinical lab environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.
Physical demands:
Communicating Verbally
- expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.Hearing
- the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.Keyboarding
- entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.Lifting
- raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.Near Visual Acuity
- clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).Pushing
- Exerting force upon an object so that the object moves away from the object.Pulling
- Exerting force upon an object so that the object moves toward the force.Sitting
- remaining in a sitting position for at least 50% of the time.Standing/Walking
- remain on one's feet in an upright position at a workstation.Stooping
- occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Required education and experience:
The job title will be determined based on the candidate's qualifications and years of experience.Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field. A higher degree is preferred.Extensive experience (4+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch releaseAt least 4+ years of Biotechnology and/or pharmaceutical industry experience is required.Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.Familiarity with relevant standards, such as cGMP (current Good Manufacturing Practice) and GCP (Good Clinical Practice).In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams and interact with regulatory agencies.Strong attention to detail, problem-solving abilities, and the ability to prioritize and manage multiple tasks simultaneously.Proactive mindset and a commitment to continuous improvement in quality assurance processes and practices.
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for 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. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.