The main role of the Microbiology Manager within the Quality Control Team is to provide daily operational support and manage the Microbiology Laboratory and Environmental Monitoring (EM) Program. The Microbiology Manager will lead a team and will provide EM services to the Immatics aseptic production areas, monitor manufacturing batches, and perform/provide safety testing results for final drug product release.
- Scheduling testing programs (sterility, endotoxin, and mycoplasma) and performing microbial testing
- EM of the classified aseptic production areas including incubation of samples, reading of results, reporting, and approving data (EM activities include but are not limited to contact plates, viable/non-viable counts, microbial ID testing/send-outs, and operator monitoring)
- Performing trending of data for quarterly reports and investigating EM excursions including OOS results
- Authoring or reviewing study plans and research reports
- Performing sterility, endotoxin, and mycoplasma matrix verifications as per USP and EP guidelines
- Writing and reviewing SOPs and other documentation under cGMP environments
- Performing microbial method qualification and growth promotion.
- Supporting aseptic media fill process simulation validations.
- Overseeing QC micro equipment validation, maintenance and calibration
- General laboratory operations (ordering supplies and culture media, operating laboratory equipment, sample receipt, lab notebooks, authoring/reviewing/checking for integrity of records and data)
- Assisting with microbial testing for raw materials where applicable
- Maintaining departmental stock cultures
- Works independently
- Strong communicator and collaborates effectively with coworkers and between departments
- Leadership and management skills and ability to foster a team environment
- Flexible and able to work under pressure and meet project timelines
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 the office building could involve exposure to manufacturing operations, along with outdoor conditions and temperatures
- Must be able to bend to perform aseptic gowning and lift up to 25lbs
Required education and experience
- BS/MS/PhD in Microbiology/Biology. PhD 3-5 years, MS 7+ or BS with 10+ years of relevant experience in QC or equivalent experience in GMP/pharmaceutical industry is required
- Working knowledge of aseptic manufacturing environmental monitoring of sterile areas is required
- Prior management of direct reports is required
- Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin, Morphology, Gram Stain and Microbial Identification) and managing testing by compendial methods
- Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance
Preferred education and experience
- Knowledge of cGMP regulations and FDA guidance related to manufacturing of sterile and non-sterile pharmaceutical products is a plus
- Prior experience with data review, writing SOPS, Change Controls, out of specification investigations and report writing under cGMP is recommended.
- Previous experience assisting with Facility Validation and EMPQ is strongly recommended
Additional eligibility requirements:
Must be eligible to work in the US
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.”
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.
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)
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.
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.