Contract Manufacturing Job Description
Contract Manufacturing Duties & Responsibilities
To write an effective contract manufacturing job description, begin by listing detailed duties, responsibilities and expectations. We have included contract manufacturing job description templates that you can modify and use.
Sample responsibilities for this position include:
Contract Manufacturing Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Contract Manufacturing
List any licenses or certifications required by the position: APICS, PPI, HACCP, NITEC, LEAN, PCQI, AIRS, CPM, AX, SQF
Education for Contract Manufacturing
Typically a job would require a certain level of education.
Employers hiring for the contract manufacturing job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Manufacturing, Associates, Chemistry, Business, Biology, Science, Chemical Engineering, Biochemistry, Biomedical Engineering
Skills for Contract Manufacturing
Desired skills for contract manufacturing include:
Desired experience for contract manufacturing includes:
Contract Manufacturing Examples
Contract Manufacturing Job Description
- Troubleshoot equipment and process failures
- Contribute to the selection contract manufacturers for audit
- Collaborates with internal cross-functional teams and CMOs to determine manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended
- Drives contract manufacturer capability and capacity to enable on-time and predictable delivery of products and projects
- Identifies and champions process improvement, and solutions to complex issues at the CMOs
- Provides visibility to key stakeholders on all CMO matters, tactical & strategic, and manages stakeholder priorities across all Neurocrine activities at the CMOs
- Manages the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met
- Develops, executes and owns the supplier selection and management processes including relevant scorecards, to ensure appropriate controls, oversight and monitoring are in place
- Partners with key stakeholders in the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
- Partners with Neurocrine Quality Assurance to ensure CMOs are in compliance with all cGMP guidelines and Neurocrine SOP requirements
- Align with the Business Unit defining key elements of success
- Profile and understand our leverage in the market
- Demonstrated strong communication and negotiation skills are required
- Operational Excellence Certification (Process Excellence, Lean)
- The Senior Manufacturing Engineer shall possess a third level degree qualification in an Engineering, Manufacturing, or other technical field
- Ability to develop complex contracts and work with legal counsel
Contract Manufacturing Job Description
- Collaborate with manufacturing engineering and program manager to prepare engine workscope in order to estimate engine shop visit cost and Lead Time
- Collaborate with manufacturing engineering to keep aligned MRP data and BOM (Bill of Materials)
- Expedite orders to meet production scheduled date
- Collaborate with logistic to ensure a smooth customs and receiving process
- Verify materials conformity to engine configuration
- Support supervisor during engines accumulation process
- Plan the development and/or acquisition of required talent though development of skills and capabilities in the appropriate Manufacturing OEM field
- Lead the Lean Six Sigma and continuous improvement initiatives within Manufacturing including project tracking and mentoring of other team members projects and facilitating colleagues through lean six sigma green belt programs
- Report, Presentation and action key departmental KPI’s
- Change management inclusive of implementing end to end process changes within the quality systems including the creating of BOM’s, Master Batch record and SOP changes
- Master’s Degree (preferably engineering, business administration, operations management, supply chain or related field)
- Must have demonstrated businesses acumen coupled with a strong attention to detail
- Solid modeling experience (ProE, SolidWorks)
- Direct and proven CMO and Manufacturing Operations experience, including tech transfer, validation and commercial scale production
- Demonstrated success in project planning, resource management, and collaboration with Development, Quality and CMC
- Demonstrated ability to negotiate and manage contracts, and establish and control budgets
Contract Manufacturing Job Description
- Interface with supply chain on planning the manufacture schedule within a multiproduct facility to drive efficient manufacture campaigns to the customer schedule
- SAP local key user including administration and optimization
- Coordinate with Design Engineers to ensure the manufacturability and producibility of high quality detail design and manufacturing drawings within schedule requirements
- Reviews and ensures tool, manufacturing process design, production facility layout and production flow, test and support production of MLS’ family of products
- Participate in component design, systems and sub-assemblies new design, product improvements or enhancements, identify production problems and recommend resolution
- Create tooling model and drawing in Solid Works or CAD system using digital mockup to aid manufacturing in animation, interference analysis, validate for models based assembly and evaluate massive assembly options
- Perform basic engineering calculations, failure analysis, cost and scheduling estimates and write manufacturing specifications, shop order, and formulate sketches
- Provide manufacturing producibility support to designers, draftsmen, and engineers for technical data package delivery
- Must respond positively to changing roles/responsibilities while working in a high-paced, challenging work environment
- Primary contact and relationship manager to specified Contract Manufacturing Organization(s) for a single product or for the entire relationship depending on the size and tier of the supplier
- Demonstrated ability to lead a team, and get things done through influence in a matrix environment
- Strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations
- Strong compliance orientation and attention to detail within a cGMP environment
- Experience with manufacturing of solid oral dosage products, including API, drug product and packaging
- Direct experience with new product launches
- Knowledge of Lean / Six Sigma and risk management tools (e.g., FMEA)
Contract Manufacturing Job Description
- Strive to ensure lowest delivered cost whether turn-key vs
- Knowledge of financial budgeting processes with cost control and expense management acumen
- Maintain a running status for each contract manufacturing Order from the time it is issued until it is completed and the finished product is in stock and the costs correct on the order
- Coordinate CM Order requirements related to material movement and requirements, inventory usage, material lot numbers and system transactions with various departments, , Planning, Production, Purchasing, Inventory, Shipping, Inventory and suppliers/vendors
- Review emails throughout the day for vendors requesting more quantities or what quantities were sent for a certain order
- OWork in compliance with the provisions of the Act and the regulations
- OUse or wear the equipment, protective devices or clothing that his employer requires to be used or worn
- OReport to his or her employer or supervisor the absence of or defect in any equipment or protective device of which the worker is aware and which may endanger himself, herself or another worker
- OReport to his or her employer or supervisor any contravention of the Act or the regulations or the existence of any hazard of which he or she knows
- OShall not remove or make ineffective any protective device
- BS degree in Engineering discipline (Manufacturing, Mechanical, Industrial, Operations Research)
- 2+ years of increasingly complex engineering responsibilities
- IQ, PC, OQ, PQ
- DOE, SPC, FMEA, GMP, QSR
- A minimum of 10 years of experience as a Role Model Leader, including at least 5 years of experience as a senior functional leader in a manufacturing environment
- Comprehensive experience with a wide range of electro-mechanical products and manufacturing methods
Contract Manufacturing Job Description
- Evaluate and approve designs for new stamping dies and automated equipment
- Investigate and recommend new manufacturing methods and technologies
- Reduce costs when possible
- Provide technical assistance for fabrication and assembly process problems
- Evaluate product sourcing networks and vendors to ensure best service & quality at a competitive price
- Resolve inventory, service and cost issues by working with Plants, Divisions and R&D
- Provide regulatory filing supports (IND, BLA, MAA)
- Understand the key performance metrics and the implication
- Collaborate with CM managers to build up metrics to measure the performance for internal and external parties involved
- Automate the report to provide regular update on the metrics
- Relevant 3rd Level Qualification (Ideally Engineering)
- 2-3 years’ experience working in a front line role (such as supervisor, coordinator or specialist etc) within a production manufacturing environment (Oral Solid Dosage ideally)
- Experience in Project Management (Advantage)
- Proven ability to Lead Equipment/Production Improvement Initiatives
- Proven ability to generate or develop production/equipment performance KPIs
- Three plus years of related manufacturing engineering experience in a shipbuilding or marine industry