QC Particulate Manager

Nature and Scope

The QC Particulate Manager is responsible for providing leadership for planning and operations of the QC Particulate Laboratory.  The QC Particulate Laboratory performs both Quality Control, Forensic and R & D initiatives, and also encompasses a workstream for test set creation and certification.  Primary functions include staffing, mentoring, and managing the daily operations of the Laboratory.  Responsibilities extend to the particle related programs, test sets and events at the Ohio and California American Regent sites.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Guide Supervisors in daily lab operations.

• Monitor the product release and stability testing program and provide guidance on staff development.

• Stay current on industry guidance and compliance expectations for particulates in the pharmaceutical industry (USP 788 & 790).

• Develop and maintain a team of individuals proficient in forensic sciences.

• Demonstrate focused management skills with ability to define discrete goals, explain and deliver objectives, and evaluate technical equipment and lab capability.

• Apply scientific process to obtain information for unknowns using a Quality approach and draw sound conclusions.

• Understand current manufacturing processes for all ARI sites.

• Design experimental protocols, and author complex report documents.

• Support regulatory filings through container closure and delamination studies.

• Partner with R & D for the Development of new products, and difficult to inspect products.

• Perform appropriate investigations for atypical results.

• Review and Approve Internal and External Protocols and Reports.

• Provide guidance interdepartmentally for particulate related aspects and events.

• Work interactively with cross-functional teams (e.g., R&D, Production, Quality Assurance) to attain project goals.

• Develop programs/initiatives for information sharing and staff development.

• Working knowledge and application of analytical method validation.

• Working knowledge of Automated and Visual Inspection techniques.

• Stay current on emerging technologies for the inspection of difficult to inspect products.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor’s Degree in a scientific discipline, chemistry or microbiology required; master’s degree, preferred.

• Minimum 5 years’ experience with hands-on application in a pharmaceutical Quality laboratory environment, preferably with particulate testing or forensic analysis.

• Minimum of 3 years’ experience in leading teams in a pharmaceutical Quality laboratory environment.

• Knowledge of FDA, ICH (International Council for Harmonization), SOP & cGMP standards, guidelines and regulatory compliance regulations, preferred.

• Working knowledge of pharmaceutical laboratory and aseptic processes is required.

• Knowledge of MS Word, Excel and Outlook.

• Advanced problem-solving skills, attention to details.

• Demonstrated ability to utilize and integrate internal and external resources to meet analytical challenges for project timeline.

• Team-oriented and goal driven.

• Excellent organizational skills.

• Excellent verbal and written communication skills.

 Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

Expected Salary range:

$115,500 - $135,000

The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.  Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users.  If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

Salary : $115,500 - $135,000