Microbiology Lead, Quality Control

Organization
Catalent Pharma Solutions
Job Location
Madison, WI
Job Description

This position will perform a variety of laboratory procedures in the Quality Control group at the Catalent Madison site. The basic function is to perform high throughput micro/molecular biological sample analysis, oversee/coordinate the environmental monitoring program day to day activities and assist the QC Manager with resource planning. The QC Micro Lead will also drive process, safety and efficiency improvements; provide line level mentorship to junior analysts in scientific and regulatory activities.

Primary Location
United States-WI-Madison

Organization
Advanced Delivery Technologies (ADT)

Schedule
Full-time

Requirements: 

Qualifications

- Ph.D. in Microbiology, or related field with at least 4 years of laboratory experience.

- MS in Microbiology, or related field with at least 6 years of laboratory experience.

- B.S/B.A. in Microbiology, or related field with at least 8 years of laboratory experience.

Experience:

- cGMP documentation and experience

- Environmental Monitoring experience

- Experience writing Standard Operating Procedures and methods

- Experience with Microbiological OOS and atypical investigations (including root cause analysis).

Knowledge/Skills Requirements:

- Monitor/Oversee bioburden, endotoxin and mycoplasma testing of raw materials, in-process samples and bulk products.

- Monitor/evaluate process water for bioburden, endotoxin, TOC and conductivity as per USP requirements.

- Ensure and maintain QC equipment – qualification, calibration and maintenance.

- Proven track record to troubleshoot assays and various analytical equipment.

- Drive the development and validation of QC micro methods. Work in conjunction with other departments to develop, qualify and transfer QC methods.

- Required to communicate effectively and follow detailed written and verbal instruction.

- Ability to integrate timelines, devise batch records and meet milestones for successful project completion.

- Ability to set deadlines and prioritize work for self, group members and support groups involved.

- Write, edit and review Standard Operating Procedures (SOPs)

- Ability to peer review laboratory records to ensure data is well organized and documentation is complete.

- Independent data interpretation, trend analysis and ability to provide consultation into potential issues and solutions.

- Positive attitude and ability to work with others.

- Ability to independently complete investigation, deviation and change control forms

- Monitors quality of analyst lab work within the group and provides mentorship on scientific and regulatory conduct.

- Ability to identify and drive process improvements.

- Ability to work both independently and with a team of individuals to meet goals

- Strong organizational skills.

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Job
Quality/Regulatory

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