Working @ Immatics

Process Validation Manager

Permanent employee, Full-time · Houston (TX)

Overview
The Process Validation Manager will have a matrix leadership role that works with multiple groups including CMC Process Development, GMP manufacturing, Manufacturing Science and Technologies (MSAT), and Facilities & Operations.  
Your mission
Essential functions: 
  • The Process Validation Manager will have a matrix leadership role that works with multiple groups including CMC Process Development, GMP manufacturing, Manufacturing Science and Technologies (MSAT), and Facilities & Operations. Below are the responsibilities of this position: 
  • Responsible for establishing the process transfer and process validation framework including generating related Guidances/Policies/SOPs/Plans or Protocols and provide leadership, management, and oversight to day-to-day transfer and validation activities. 
  • Provide guidance on process transfer and support activities to junior members of the team. 
  • Own, manage, and monitor functional area/manufacturing projects and tasks and drive cross-functional projects to completion (such as Technology transfers, capital projects, campaign support, and readiness). 
  • Collaborate with Facility Manager and Equipment & Validation Manager to establish approved validation SOPs/Plans/Policies for a GMP cell therapy manufacturing facility with systems and people to ensure full cGMP compliance by operations launch.  
  • Responsible for owning and driving manufacturing improvement projects that support department KPI’s from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, innovation, on-time delivery and right first-time performance.  
  • Develop strategy, perform, and document detailed evaluation on critical validation processes and/or studies, including justification/rationale for approach, methodology, acceptance criteria and impact to product quality. 
  • Coordinate the validation, implementation, and maintenance of MES computer systems software, related interfaces, and infrastructure 
Competencies: 
  • Ability to be highly functional in a fast-paced dynamic company with the ability to prioritize issues under differing pressures and to work collaboratively with cross-functional teams. 
  • Excellent written and verbal communication skills. 
  • Highly organized and strong attention to detail 
  • Independent worker who works effectively in a team environment 
 Work environment: 
This position works in a typical office environment with moderate noise levels and uses phone, computer, office equipment, and supplies on a regular basis. 
 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 regularly required to talk, hear, and use his or her hands and fingers, to handle or feel. The employee is required to sit for extended periods of time, and occasionally required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl, lift, push or pull objects up to 10 pounds.  

 Travel required: 
This position requires occasional domestic travel 
Your profile
Required education and experience 
  • Bachelor's in engineering, biology or related science field 
  • Five (5) years of experience in pharmaceutical, biotechnology, or academic environment managing projects in CMC areas or formulation development. 
  • Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively create, review, and approve protocols and reports and support implementation activities 
  • Industry experience in manufacturing process scale up, process validation, and campaign readiness 
  • Advanced technical knowledge of manufacturing operations and understanding of batch record procedures, and other documentation required for manufacturing execution. 
  • Familiarity with QbD approach and creation of documentation such as QTPP, CQA, Process and Raw Material Risk Assessments, CPPs and Control Strategy. 
  • Demonstrated ability to manage medium to large sized projects within required timeframes 

Preferred education and experience 
  •  Knowledge of US/EU regulatory regulations and statistical data analysis is preferred 
  • Direct experience with Cell Therapy equipment such as LOVO, Sepax, CliniMACS, Prodigy, etc. is preferred 
  • Experience with Microsoft Project or other applicable Project Management tools 
  • Experience with Lean Manufacturing and/or Operation Excellence is preferred 

Additional eligibility requirements: 
 N/A 


Work authorization/security clearance requirements 
Must be authorized to work in the United States 
Why us?
What Immatics Offers 
We are a committed and inspired company and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills. In addition, we offer:  
  • Competitive Total Rewards package 
  • Base Salary  
  • Annual Bonus  
  • Stock Options – based on position level  
  • 401K plan with company match  
  • Generous Holiday Time  
  • Generous Paid Time Off (PTO) for ALL EMPLOYEES regardless of position level 
  • Full Benefits 
  • Health Insurance  
  • Dental/Vision insurance   
  • Short-Term and Long-Term Disability  
  • Other voluntary insurance (Pet, Legal Shield Identity Theft Protection, Travel Assistant, Accidental Injury and Critical Illness,) 
  • Family Medical Leave 
  • Parental Leave  
  • Employee Assistance Program 
  • Life Insurance policy  
  • Additional Voluntary Life Insurance 
  • Personal time with the CEO in your first 30 days  
  • Collaborative and family environment 
  • Monthly Site meetings with fun team building events 
  • Participation in the annual Houston BioChili Cookoff  
  • Themed Holiday party  
  • Social Community Outreach participation  
  • Development training and planning  
  • Various committees to foster collaboration and involvement within Immatics  
  • Hybrid work schedules (based on position need and supervisor’s approval) 
Notice
Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed.   
 
Immatics values diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.    
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.

This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.