Job Summary:
Responsible for supervising manufacturing operations in a 24 hour shift based manufacturing plant. Assigns and deploys shift leads to meet operational goals which include driving process excellence, process improvement, reducing variation in production processes and resource utilization to efficiently meet or exceed the production schedule. Directly responsible for managing operations floor, data review and trending to drive process improvement, coordinating all support activities while driving plant efficiency, fulfilling corporate and functional objectives and developing a team with a focus on excellence and continuous improvement as a core competency and culture within a multi country regulated pharmaceutical manufacturing environment.
Job Responsibilities:
- Supervise Manufacturing and Packaging departments in achieving expected levels of safety, quality, productivity, cost and customer service over two manufacturing plant locations.
- Identify performance gaps, and develop and implement appropriate corrective actions.
- Develop, implement and manage continuous improvement plans (Lean) within the function in support of the company's overall objectives and goals for growth, opex, profitability, productivity, reliability, labor utilization, product quality and GMP compliance
- Manage the timely introduction and technical transfer of new products into the commercial environment
- Work with customers and internal functions to effectively transfer and validate new or revised manufacturing/packaging processes and technologies
- Ensure that production schedules meet both internal and external customer service commitments
- Participate in the development of the necessary metrics and key performance indicators to monitor and ensure actions are taken to achieve or exceed the goals and objectives
- Manage functional assets and overall capacity needs effectively and economically
- Identify and correct constraints
- Provide direct supervision and coaching of staff
- Conduct annual performance reviews of staff ensuring the performance management process is strictly adhered to
- Participate in budget review in accordance with organizational strategies and goals
- Review staffing, capital and expense budget items on a continuous basis to ensure cost effective and GMP compliant operations
- Ensure that the workplace is maintained in a GMP-compliant and safe operating condition and that all colleagues are following all required policies and procedures
- Ensure the efficient and economical utilization of all labor resources and equipment assets
- Ensure that daily operating results are reported and communicated to the operations colleagues through daily shift communication/exchange meetings and that gaps are identified and action is taken
- Complete all manufacturing processes and documentation (batch records) with "right the first time" in being accurately documented and reviewed on time
- Ensure that SOPs/WIs are developed, maintained and revisions are completed and approved within expected time lines
- Ensure all Production related Events are complete and have effective and timely CAPA implementations and follow-up is done accurately and on a timely basis partnering with Quality and the Investigation Manager
- Review and approve manufacturing labor reports for commercial production to ensure cost-effective operations
- Support the development of new or revised manufacturing instructions and ensure that manufacturing master batch records are approved and maintained current
- Manage operations training, colleague relations and company policies, including scorecard program, recruitment and hiring, performance appraisals, salary review and progressive discipline
- Responsible for meeting production goals and personal objectives
- Responsible for directing shift leads in shift schedule to include: work assignments, colleague training, colleague vacations, colleague breaks, overtime assignment, back-up for absent colleagues, etc
- Partners with QA, Maintenance, Engineering, and QC to accomplish site objectives.
- Other duties as assigned.
Job Qualifications:
- Bachelor's Degree or Associates degree in scientific field preferred
- 3+ years leading, managing or supervising direct reports in a manufacturing environment (regulated manufacturing experience in pharmaceutical, food, or medical device strongly preferred)
- Proven leadership and management skills
- Must be detailed oriented
- Self-starter with good time management skills
- Diplomatic problem solving skills
- Strong organizational and communication skills
- Must be able to multi-task and prioritize workloads effectively
- Have a collaborative management style
- Statistical Process Analytics including spread sheet and data base applications.
- Experienced in problem solving techniques
- Opex experience including Lean Manufacturing or Six Sigma
- Technical writing
- Able to thrive and adapt in a dynamic environment
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.