Director of Manufacturing

Purpose and Scope

Provides management oversight and leadership for the General production and Aseptic Production areas. Ensures scheduling, budget, delivery, and other production objectives are met. Ensures compliance with FDA cGMP regulations and works cooperatively with Management team to plan and direct Tolmar operations in accordance with customer and partners needs.

Essential Duties & Responsibilities

• Responsible to identify training needs within the department and ensure training requirements are met
• Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate
• Manage the day-to-day activities of manufacturing operations
• Prepare weekly production schedules, communicate and monitor.
• Update MRP system with product forecast and sales orders.
• Coordinate activities related to availability of product between quality, process development, manufacturing and clinical.
• Interact with customers and vendors.
• Develop production records and work instructions in conjunction with process development.
• Project leader for new products being introduced to manufacturing.
• Ensure compliance to cGMP and ISO 9001.
• Manage cost and work with accounting on monthly closing.
• Maintain FourthShift Software (MRP system) – update Bills of Material add new items as needed.
• Perform other related duties as assigned..

Knowledge, Skills & Abilities

• Excellent knowledge of current Good Manufacturing Practices (cGMP)
• Working knowledge of purchasing, inventory flow, including receiving, issuance to manufacturing, and shipping, production planning and scheduling.
• Working knowledge of business financial fundamentals.
• Excellent oral and written communication skills
• Excellent supervisory and leadership skills.
• Skill in solving diverse and challenging problems.
• Ability to manage multiple projects concurrently and under tight time constraints
• Ability to work with MRP system.

Core Values

• The Director Manufacturing 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.

Education & Experience

• Bachelor’s degree or equivalent experience.
• Ten or more year’s experience in manufacturing in a regulated industry preferably in the pharmaceutical industry.
• Minimum six year’s experience in a management role specific to manufacturing.

Working Conditions

• Working conditions are normal for an office environment. Some overtime and weekends may be necessary.

Compensation and Benefits

• Pay: $175,000 - $210,000, depending on experience
• Bonus eligible
• Benefits information: 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.

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)