Senior Manager of Manufacturing

Nature and Scope

• The Senior Manager of manufacturing will be responsible for managing and leading the day-to-day operations for the commercial aseptic manufacturing of drug and device products. The position scope can include any arrangement of the following departments: Compounding, Equipment/ Component Preparation, Sterile Filling, Inspection and Packaging.

• Ensure that supervisors provide daily oversight of their process to reinforce that department remains in compliance with all company SOPS, maintaining data integrity for all GMP processes and any department-specific requirements. Additional compliance must be met for all regulatory requirements – FDA, OSHA, OFCCP, EPA, etc.

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.

Strategic Focus

• Drives operational excellence in accordance with short and long-term organizational objectives and strategic focus through leadership & technical expertise for continuous development of people & team, quality expectations, compliance, safety, customer and financial goals.

• Provides leadership and technical guidance for all manufacturing personnel in order to foster a healthy environment and culture that is collaborative, innovative and which promotes operational excellence.

People / Team Development

• Responsible for providing key leadership, communication, and organizational management of both non-exempt & exempt personnel including, process supervisors.

• Responsible for the hiring, development and coaching of employees in order to ensure optimal level of performance by all manufacturing personnel.

• Ensure that prospective candidates, who are hired into the business, align with the strategic direction of the manufacturing organization and to help foster a learning organization that exhibits leadership, personal accountability, and a strong sense of purpose and urgency.

• Commit to employee feedback and developmental processes through a communication plan, mentoring, technical acumen, and leadership development.

Operational Excellence

• Foster a culture of continuous improvement through employee selection, training and mentoring whilst focusing on operational efficiency and the elimination of “non-value added” activities.

• Support plant-wide strategic plans, programs and activities.

• Work collaboratively with inter- department and cross-functional teams and to act as a change agent whilst leading in a timely and productive manner.

• Identify and follow up/lead opportunities that contribute to the improvement of current manufacturing processes and practices.

• Manage and lead the daily manufacturing operations across a single or multiple value streams.

Quality, Compliance & Safety

• Responsible for assuring compliances with all regulatory requirements – FDA, OSHA, OFCCP, EPA, etc.

• Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any department-specific requirements.

• Ensures adherence to production schedules, while holding Supervisors and teams responsible for compliance with all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet scheduled attainment objectives.

• Ensuring inspection readiness of all manufacturing areas.

• Participates in inspections conducted by external / internal regulators and ensures the success of departmental audits.

• Interfaces directly with customers and regulatory personnel during plant audits and inspections.

• Is responsible for “on-time” completion of investigations, CAPA’s for major and critical deviations and QE’s.

• Reviews and approves Quality Reports, validation protocols and reports.

• Manages Change Controls

• Complies with requirements from American Regent’s Safety Program, including Health and Safety mandates and OSHA requirements.

• Ensures the accuracy of all manufacturing management tools/systems and documentation (eg. SOP’s, OJT’s).

• Partners with Manufacturing Engineering/Product Manager in order to troubleshoot and foster the resolution of process issues by continuously and proactively driving projects to improve manufacturing processes.

• Ensures consistency in the adherence of personnel policy administration including attendance control and Disciplinary Policy.

Customer

• Ensures timely deliverance of products to internal & external customers so that product quality, yield, operating costs and process efficiencies/expectations are satisfied.

• Interfaces with the other managers/customers to ensure our quality commitments are satisfied.

• Participates/leads the scheduling of projects and staff meetings in conjunction with providing updates on departmental activities and project statuses.

• Ensures timely escalation of manufacturing issue(s) related to management and other cross-functional support teams as may be necessary.

• Advises senior management on production issues and vulnerabilities. Develop proposals for improvement and risk mitigation.

Financial

• Ensures profitability [EBITDA] by challenging the status quo and striving for operational excellence for 1st time right product lots/Batch Records, utilization of labor thereby increasing acceptable units and finished good yields, throughput and Overall Equipment Effectiveness [OEE].

• Increase efficiency and profitability through the minimization of production downtime, WIP Inventory, manufacturing cycle time and “set-up” reduction.

• Optimize resources within assigned areas in order to adhere to compliance standards and cost discipline.

Job Complexity

• The Senior Manager of Manufacturing will be responsible for the manufacture and delivery of drug products that meets internal and external customer expectations. This job requires leadership, interpersonal, organizational and team-building skills.

• Erroneous or mistimed decisions may result in critical delays thereby negatively impacting cost and may have an immediate effect on the company’s success.

Supervisory Responsibilities

• Responsible for the managers and supervisors in the manufacturing of all commercial filled products that are aseptically and terminally sterilized.

• 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.

• B.A. or B.S. degree, required. Master’s degree, preferred.

• Minimum of 5 years of previous supervisory experience in a cGMP regulated industry.

• Minimum of 7 years of experience in aseptic manufacturing, pharmaceutical or medical industry and with a progressive experience leading to a management position.

• Ability to work autonomously, manages time effectively and deliver results in a timely manner.

• Strong oral and written communication skills.

• Strong time management, organizational and project management skills.

• Knowledge of MS Applications (Word/Excel/Outlook/Power Point).

• Aseptic manufacturing, isolator technology and cleanroom experience.

Expected Salary Range:

$156,000 - $185,000

The salary range, displayed is the minimum and maximum annual salary range of compensation 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

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