Sr. Manager - Microbiology
This is where
This is where your creativity addresses challenges
Your Team at Baxter
What you'll be doing
- Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished good products.
- Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
- Ensure compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and other relevant regulations and standards.
- Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
- Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
- Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
- Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
- Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
- Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
- Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
- Manages the coaching, training and development process of subordinates.
- Sustain a clean and safe work area using 6S principles.
What you'll bring
- Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
- Minimum 10 years professional experience in Quality, Manufacturing, Engineering or related field.
- Minimum 7 years confirmed experience in cGMP related industry.
- Minimum 5 years proven leadership/supervision and experience within an aseptic or sterile manufacturing site.
- Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
- Familiarity with regulatory requirements including USP, FDA, and ISO standards.
- Demonstration of leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving skills.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentives. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Other Duties as Assigned
US Benefits at Baxter (except for Puerto Rico)
Equal Employment Opportunity
Reasonable Accommodations
Recruitment Fraud Notice
Not included in the source posting: what you'll do, qualifications.
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
Read automatically from the employer's posting text. Always confirm with the employer — requirements can change after a job is published.