Supervisor Production Paliperidone (Onsite)

Description

Core Hours will be 9 : 00am - 5 : 30pm Monday - Friday throughout 2024. At the beginning of 2025, this role will move to 3rd Shift (Monday - Friday 10 : 00pm - 6 : 30am)

Purpose and Scope

The Production Supervisor performs activities related to supporting the injectable team, while ensuring that products are made with quality for our patients.

Supervises and coordinates shift production activities and related staffing, scheduling and planning in manufacturing.

Key Responsibilities

• Demonstrates a high degree of honesty, initiative, integrity, drive, reliability and trustworthiness.
• Actively models and fosters a positive, respectful, and harassment-free work environment for all employees.
• Actively supervises and manages the performance of hourly manufacturing employees in the aseptic manufacturing group.
• Conducts interviews and participates in making hiring decisions for hourly employees.
• Ensures open and transparent communication to the hourly employees about company priorities, policies and general company announcements.
• Identifies, proposes and supports implementation of process improvements and optimizations of the aseptic manufacturing processes.
• Communicates and sets daily production priorities with Process Leads and hourly employees.
• Responsible for the coordination of various processing steps for specialty injectable products to ensure critical time limits are adhered to and product quality meets specifications.
• Accurately evaluates and reviews technical process data and provides approval for further processing if process parameters are met.
• Monitors and tracks in-process and sterile hold times throughout critical manufacturing processes to ensure time limits are met.
• Oversees the work of the Process Lead and Specialty Injectable Bulk Operator who conducts or coordinates the in-process training, including line orientation and risk review, of all new team members.
• Responsible for monitoring the training progress and readiness to work independently for all direct reports.
• Ensures production team adheres to all quality standards and specifications.
• Creates, revises and implements Standard Operating Procedures (SOPs) and Production Batch Records.
• Performs Batch Record review, including prioritization, reviewing corrections, and following up to ensure timely completion.
• Performs transactions in the Inventory Control System (FourthShift) on a timely basis.
• Performs investigations and CAPA implementations for non-conforming events.
• Pre-approves expiration dates on batch records prior to manufacturing.
• Proactively and effectively manages performance of their team.
• Conducts employee performance evaluations.
• Reviews and approves direct report timesheets.
• Performs other related duties as assigned.

Special Skills and Knowledge

• Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to sterile injectable manufacturing.
• Ability to stand for extended periods of time (up to 8 hours or more).
• Proficient in Microsoft Office (Excel, Word, Outlook).
• Strong math, writing, and technical skills.
• Strong attention to detail.
• Full understanding of scientific units of measure and methods for converting units of measure.
• Working knowledge of proper rounding techniques for numerical data.
• Ability to evaluate graphical data plots to verify process parameters and processing end points.
• Ability to keep accurate records and able to perform mathematical calculation.
• Ability to quickly make decisions and understand the impact on processes and product quality.
• Strong understanding of how critical process parameters impact finished product quality attributes.
• Understanding of chemistry and microbiology concepts relevant to the manufacture of sterile, specialty injectable products in an aseptic clean room environment.
• Strong working knowledge of advanced pharmaceutical manufacturing.
• Excellent verbal and written communication skills.
• Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements.
• Ability to legibly complete required documentation.
• Strong analytical and problem solving skills.
• Ability to support management decisions and communicate change positively.
• Ability to demonstrate ownership for their responsibilities and their team's performance.
• Ability to complete donning of personal protective equipment and showering during the de-gowning process.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.

Core Values

• The Production Supervisor is expected to operate within the framework of Tolmar's Core Values :
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Communication

• Interacts with peers and members of other departments in team settings in a professional manner.
• Provides consistent coaching, guidance, development and mentorship to operators and technicians.
• Maintains open and constructive dialogue with other leaders.
• Ability to communicate technical details of manufacturing process to members of management.

Education & Experience

• High school diploma or equivalent required.
• Bachelor's degree in scientific discipline or related field or equivalent experience required.
• Three or more years of experience in a manufacturing role in regulated industry (food, aerospace, chemical, electronics), preferably the pharmaceutical industry.
• Experience in advanced or complex manufacturing processes preferred.

Additional Requirements

• Valid driver's license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.

Compensation and Benefits

• Pay range : $83,000 - $88,000 depending on experience
• Shift differential : 10%
• Bonus eligible
• Benefits summary : https : / / www.tolmar.com / careers / employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.

It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)