Job Information
Mallinckrodt Pharmaceuticals Senior Manager, Manufacturing in Port Allen, Louisiana
Job Title
Senior Manager, Manufacturing
Requisition
JR000014237 Senior Manager, Manufacturing (Open)
Location
CC-Port Allen - USA502
Additional Locations
Port Allen, LA
Job Description
The Senior Manager, Manufacturing oversees resources to ensure manufacturing and packaging systems meet standards, regulatory requirements, and business goals. The Senior Manager, Manufacturing manages production supervisors and teams across multiple shifts, contribute to the site's strategic direction, implement operational standards, and drive initiatives to enhance safety, quality, cost, and customer service across Mallinckrodt sites.
Responsibilities:
Oversee resources for INOmax product manufacturing, medical device, and gas standards production, ensuring compliance with cGMP, safety, and environmental policies.
Drive proactive planning, continuous quality improvement, and cost-effective problem-solving.
Provide technical leadership and collaborate with engineering for efficient processes.
Lead process improvement projects to reduce costs, enhance quality, and increase efficiency and capacity.
Manage manufacturing budgets and activities, including product investigations and process expertise.
Maintain 24/7 availability for facility advocacy and improvement as a pharmaceutical production expert.
Essential Functions
Coordinate with Planning and Scheduling to develop an executable schedule to meet company needs. Communicate and ensure understanding of area objectives, schedules, procedures, and issues.
Implement and drive performance metrics that are related to Right First Time (RFT) goals. Partner with Quality Assurance to develop and maintain metrics to ensure a holistic approach to meeting site RFT goals.
Conduct Gemba walks to monitor activities on the floor and accomplish area objectives as well as to identify and resolve issues.
Evaluate deviations and trends to assure the quality and integrity of equipment, processes, and final products.
Work cross functionally with area leaders in the resolution of daily production/equipment issues, improving equipment and processes, and establishing metrics.
Proactively interact with support functions to ensure achievement of production schedule and overall business objectives. Ensure that the production groups are properly trained, and employees perform duties according to approved Manufacturing policies, Standard Operating Procedures, guidelines for Safety, and all applicable current Good Manufacturing Practices.
Ensure ongoing performance and coaching dialogue between supervisors and team members.
Identify and implement changes to improve the quality of products, processes & services.
Foster, build & support collaborative relationships at all levels of the organization as well as within external constituents through coordinated systems of training and development.
Provide leadership and execution expertise in the following areas: Production of the bulk drug substance; Production of finished products; Safety and Health of Employees; Compliance Documentation Lifecycle; Validation Lifecycle Support; Environmental Compliance; Staff Development; Budget Management; Technology/Efficiency Improvements
Minimum Requirements
High School Diploma or equivalent, with a minimum of 15 years of relevant supervisory experience in a cGMP pharmaceutical environment or other FDA regulated manufacturing environment, including at least 5 years leading managerial and staff-level personnel in major packaging/manufacturing or quality operations.
Strong understanding of cGMP and other government regulations appropriate to pharmaceutical manufacturing while successfully leading cGMP-compliant operations.
Demonstrated record of achievement with respect to the consumer elements relating to safety, quality, customer service, EHS, product cost, bringing new products to market, and new product introductions.
Proven leadership, management, and supervisory skills with a strong track record in developing leaders, adept at change management, and a strong commitment to mutual accountability.
Demonstrated capability to lead, align, and motivate personnel across different spheres to achieve common goals and objectives, coupled with the ability to inspire and manage employees, showcasing business acumen, leadership, effective communication, technical issue analysis, and conflict resolution.
Ability to develop long -range plans and implement projects (both technical and non-technical) to achieve objectives in a fast-paced manufacturing environment.
Demonstrated ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
Preferred:
- Bachelors or Masters in Engineering or related Scientific discipline or equivalent with 10 years relevant supervisory experience in a cGMP pharmaceutical environment or other FDA regulated manufacturing environment including at least 3 years leading managerial and staff-level personnel in major packaging/manufacturing or quality operations
Organizational Relationship/Scope:
Senior Manager Manufacturing is part of the Site Leadership Team and reports to the Site Director (General Manager). Manages a group of 20+ employees consisting of Manufacturing Leads and individual contributors
Working Conditions:
40 hours / 5-day work week in office and light industrial environment
Occasional travel (5-15%) will be required
#LI-LM1
Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.