Associate Director Manufacturing
4 weeks ago
Provide an overview of the role, including job scope / responsibilities, impact, decision authority, problem solving, level of influence, etc. The Associate Director of Manufacturing will have full day-to-day responsibility for sterile product manufacturing operations and provide strategic direction, leadership, and development of the Manufacturing team. The Associate Director will be responsible for establishing an employee-friendly, high-performance, and quality focused work culture using Lean manufacturing principles. They will ensure compliance with regulatory guidelines, i.e., cGMP, FDA, DEA. They will utilize Lean concepts in the development of a problem-solving culture and teach associates how to identify and eradicate waste, and complete root cause analysis to drive daily continuous improvement, identify and develop new product opportunities, specifically in sterile products such as injectables (liquid and lyophilized), ophthalmic and controlled substances.
Provides strategic leadership for bulk formulation, aseptic filling, and manufacturing functions, focused on safety in operations, product quality (cGMP), efficiency, and compliance (FDA, DEA, OSHA) for a portfolio of sterile pharmaceutical products.
Responsible for the delivery of product by managing daily operations with input from client/customer, Process Development, Manufacturing, Engineering, Validation, Quality Control, Microbiology / Environmental Monitoring and Quality Assurance.
Manage team to ensure safety, compliance, and production goals are reached.
Collaborate with Technical Operations to manage the workflows associated with new product introduction and product reintroduction including design of process flow, special handling requirements, equipment fit versus qualified components and processes, bill of materials (BOM) generation, process parameters, automation requirements.
Review and approve batch records, solution records, and other SOPs and protocols for new/existing products.
Review and approve deviation investigations, CAPAs, technical documents, and Change Controls associated with production. Ensure appropriate root cause investigations are completed and effective corrective/preventative actions are implemented.
Provide support to the Engineering and Validations teams in preventive maintenance, calibration and equipment and process validation / re-validation activities.
Identify and support new manufacturing equipment selection, user requirement specification development, protocol development, review and approval and qualification execution.
Provide on-the-floor technical oversight and manage client interactions as required during cGMP manufacturing runs.
Serve as SME as required during regulatory inspections for manufacturing operations, departmental training, and associated department deviations, change controls, and process documentation.
Compile, analyze, and present manufacturing process data to internal and external program teams.
Manage production deliverables associated with active campaigns in assigned manufacturing area. Ensure production teams are meeting safety, compliance, and schedule objectives.
Collaborate with Technical Operations and Quality Assurance for batch record review and release timelines. (Repeat of above so is below)
Provide on-the-floor support as required and serve as primary contact for technical aspects within each product campaign.
Hire, develop and motivate the team. Serve as a coach and mentor for reports meeting with them at a minimum frequency based on experience to assure objectives are met.
In cooperation with customer representatives, process development, engineering, and management personnel, look for opportunities to improve operational efficiencies.
Development and adherence to manufacturing department budget.
Closely coordinate potential process improvements with quality and regulatory to assure cGMP and DEA product handling compliance.
Position Requirements:
Education:
Required:
Bachelors degree in manufacturing, Operations, Mechanical or Industrial Engineering, science discipline or similar field preferred.
Minimum 10 to 15 years experience in pharmaceutical manufacturing preferred.
Experience:
Required:
Minimum five (5) years leadership experience.
Experience with glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing a plus.
Experience working/scheduling in a multiple shift, multiple product and multiple product container size change-over environment.
Strong manufacturing leadership experience in discrete manufacturing environments with demonstrable results. (Both are stated above)
Five-plus years working in strong Lean cultures.
Must have had roles with P&L responsibility and must have working knowledge of budgets and financial statements.
Skills:
Required:
cGMP, DEA, and OSHA compliance
Glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing
Strong project management abilities
Capable of interaction at all levels of the organization
Ability to manage and execute several activities at once.
Proven strategic leadership and enterprise mindset.
High level of financial acuity.
Must have a strong drive to understand unknowns, comfortable challenging status quo, prone to ask questions.
Strong understanding of US and international regulations cGMPs a plus.
Ability to translate complex concepts and information into an easy-to-understand manner to external and internal teams.
Demonstrated drive to identify improvement opportunities in products, processes, and people. Ability to provide strong rational and supporting case for proposed improvements.
Excellent written and oral proficiency in English
Strong personal presence with excellent leadership, communication, interpersonal and relationship building skills.
Working knowledge of MS Word, Excel, Outlook, and Power Point
Functional Knowledge:
Excellent conceptualizing, analytical and problem-solving skills
Company / Industry Related Knowledge:
cGMP, DEA, and OSHA compliance
Glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing
Effective written and oral communication skills
Strong organizational, planning and communication skills.
Demonstrates exceptional time management skills.
Using logic and reasoning to identify solutions to problems.
Ability to multi-task, set priorities and meet strict deadlines.
Ability to lead, motivate, coach, and teach others
Rising Pharmaceuticals Launches Edetate Calcium Disodium Injection, an Important Antidote Treatment to Address Lead Poisoning.
From our manufacturers, partners and pharmacies to physicians and their patients, our goal is to make life better for everyone we impact.
#J-18808-Ljbffr
-
Director of Manufacturing
4 weeks ago
Decatur, United States Align Production Systems Full timeABOUT ALIGN PRODUCTION SYSTEMS For 50+ years, Align Production Systems (“Align”) has partnered with Fortune 100 customers across the automotive, aerospace, heavy construction, and electrical industries to design and produce custom solutions that move heavy loads throughout a diverse base of manufacturing and plant facilities. Serving as a design and...
-
Associate Director of validations
4 weeks ago
Decatur, United States Rising Pharma Holdings, Inc. Full timeAssociate Director of Validations and Qualifications Position Title: Associate Director of Validations and Qualifications Department: Quality Reports To: VP and GM of Operations Work Location: Decatur, Illinois Position Summary: The Associate Director of Validation will be an integral part in the re-opening of our Manufacturing facility in Decatur Illinois....
-
Manufacturing Engineer
2 days ago
Decatur, United States Caterpillar Full timeCareer Area: Manufacturing Job Description: Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about...
-
Design Manufacturing Engineer
2 days ago
Decatur, United States Meridian Technologies Full timeManufacturing Design Engineer - W2 Contract Business Unit RI Operations and Products Business Center Wheeled Products Engineering Department Description Wheeled Products Light Fab Position’s Contributions to Work Group • First responder for Large Mining Truck and Large Wheel Loader manufacturing issues. • Engineering changes for manufacturing issues...
-
Design Manufacturing Engineer
16 hours ago
Decatur, United States Meridian Technologies Full timeManufacturing Design Engineer - W2 Contract Business Unit RI Operations and Products Business Center Wheeled Products Engineering Department Description Wheeled Products Light Fab Positions Contributions to Work Group First responder for Large Mining Truck and Large Wheel Loader manufacturing issues. Engineering changes for manufacturing issues and...
-
Design Manufacturing Engineer
3 days ago
Decatur, United States Meridian Technologies Full timeManufacturing Design Engineer - W2 Contract Business Unit RI Operations and Products Business Center Wheeled Products Engineering Department Description Wheeled Products Light Fab Position’s Contributions to Work Group • First responder for Large Mining Truck and Large Wheel Loader manufacturing issues.• Engineering changes for manufacturing issues and...
-
Design Manufacturing Engineer
2 days ago
Decatur, United States Meridian Technologies Full timeManufacturing Design Engineer - W2 Contract Business Unit RI Operations and Products Business Center Wheeled Products Engineering Department Description Wheeled Products Light Fab Position’s Contributions to Work Group • First responder for Large Mining Truck and Large Wheel Loader manufacturing issues.• Engineering changes for manufacturing issues and...
-
Warehouse Associate
1 week ago
Decatur, United States PrideStaff Full timePosition: Warehouse Associate. Hours: Monday - Friday, 7 AM - 3:30 PM overtime when needed. Pay Rate: $16 per hour. Dress Code: Hard sole shoes, jeans/work pants, PPE is provided. Our client is looking for warehouse associates who will be respons Warehouse Associate, Warehouse, Associate, Manufacturing, Staffing
-
Warehouse Associate
4 weeks ago
Decatur, United States The Adecco Group Full timeAdecco is seeking a dependable Warehouse Associate to join our team in Decatur, AL. The primary responsibilities include picking products, receiving materials, putting away items, labeling, unloading shipments from UPS and FedEx, and operating a fork Warehouse Associate, Warehouse, Associate, Forklift Operator, Lift Operator, Manufacturing, Staffing
-
Wellness Director
4 weeks ago
Decatur, United States Phoenix Senior Living Full timeJob DescriptionJob DescriptionDescription:The Retreat at Cascade is seeking an RN/LPN to join their team as a Wellness Director!The Wellness Director is responsible for providing overall leadership and management of the health and well-being of the residents within the community. Responsibilities include but are not limited to all clinical programs, quality...
-
SI RCM Director
4 weeks ago
Decatur, Illinois, United States Archer Daniels Midland Company (ADM) Full timeSI RCM DirectorThis is a full time, exempt level position Position Summary:The RCM Director is a key leader in building and leading change in the organization. They are considered a leader in the operations management team and are responsible for driving step change improvement of plant reliability, championing the continued move from reactive to proactive...
-
Leasing Director
2 weeks ago
Decatur, United States GrayCo Properties Full timeJob DescriptionJob DescriptionThe job of the Leasing Director for GrayCo Properties is broadly different from that of most companies. At GrayCo, the role of our leasing teams is key to the success of our company. This is a powerful position and one GrayCo strongly supports with training, operational guidelines, rewards, and incentives.QUALIFICATIONS...
-
SI RCM Director
3 days ago
Decatur, United States Limitless Decatur Full timeSI RCM Director - Decatur, IL Decatur IL - Illinois Operations: Manufacturing, Production, Maintenance, Utilities Job Description SI RCM Director This is a full time, exempt level position Position Summary: The RCM Director is a key leader in building and leading change in the organization. They are considered a leader in the operations management team and...
-
Executive Administrative Assistant
1 month ago
Decatur, United States GeorgiaGov Full timeThe Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD) is currently seeking candidates for the position of Executive Administrative Assistant to the AMH Program Director at Georgia Regional Hospital - Atlanta, located in Decatur, GA. Salary:$45, Job Grade F Job Summary : This administrative position directly reports to...
-
Senior Director/Director of Donor Relations
4 weeks ago
Decatur, Georgia, United States Northern Illinois University Foundation Full timeNIU Division of AdvancementThe division of University Advancement (UA) exists to energizeand rally the private sector to partner with the NIU community,harnessing crucial resources for our collective future. Our missionis all about empowering these connections to drive NIU's growth andinnovation. Our focus includes amplifying our students' influencelocally,...
-
Early Childhood Director
2 weeks ago
Decatur, United States dReam Kids Academy, Inc. Full timeJob DescriptionJob DescriptionPurpose of the Job:The Early Childhood Director is responsible for overseeing the daily operations of dReam Kids Academy, servicing children between the ages of 6 weeks to 4 years old. This also includes curriculum development and management, as well as staff management. The Early Childhood director will be responsible for...
-
Customization Associate
2 weeks ago
Decatur, Illinois, United States Lakeland Industries Full timeAt Lakeland Industries, our number one priority is creating protective garments that protect people from fire, hazardous chemicals, and diseases throughout the world. We design and manufacture a wide variety of technologically advanced protective clothing for workers in several industries in which hazardous materials must be handled. Lakeland Industries'...
-
Customization Associate
1 month ago
Decatur, United States Lakeland Industries Full timeJob DescriptionJob DescriptionAt Lakeland Industries, our number one priority is creating protective garments that protect people from fire, hazardous chemicals, and diseases throughout the world. We design and manufacture a wide variety of technologically advanced protective clothing for workers in several industries in which hazardous materials must be...
-
Marketing Director
4 weeks ago
Decatur, United States CareerBuilder Full timeYou have a proven track record developing and executing successful marketing strategies, with hands-on experience in state-specific marketing, you possess a nuanced understanding of cannabis markets You have exceptional communication and interpersonal skills Your strong analytical and financial skills empower you to measure success effectively, manage...
-
Director of Quality Control
2 weeks ago
Decatur, United States Rising Pharma Holdings, Inc. Full timeThe Head of Quality Control will be an instrumental part in the re-opening of our Manufacturing facility in Decatur, Illinois. This individual will be responsible for building a new QC team and a GLP compliant Quality control lab for the site. This position will also be responsible for developing QC systems and practices, maintaining cGMP Compliance,...