Supply Chain Specialist

Nesher Pharmaceuticals (Usa) LLC Saint Louis , MO 63150

Posted 3 days ago

summary

Lead materials resource planning (MRP) process and work with Procurement and quality teams to make materials available per set inventory norms to support firm production cycle. Develop and monitor monthly and weekly end to end operational schedules by integrating demand and operational efficiency. Proactively evaluate schedule attainment and work with Supply Chain, Operations, and Quality groups to minimize operational interruptions.

essential Duties and Responsibilities

  • Convert demand requirements into detailed plans and schedules for materials and operations.

  • Run and analyze ERP based materials resource planning (MRP) process.

  • Monitor materials and component inventories and collaborate with Procurement, Warehouse and Quality teams to ensure materials availability to support firm zone production cycle.

  • Monitor and analyze orders, receipt, sampling and release of raw materials and components. Proactively identify and inform gaps if any, to Supply Chain and Operation management for the risk assessment and mitigation.

  • Provide inputs for production planning governance.

  • Identify non/slow moving, obsolete inventories and provide monthly analysis to the management for the decision making.

  • Work with management to improve and integrate data processing systems to track and manage inventories and lead monthly material review governance.

  • Serve as business lead on implementing AMVL changes and associated change control requirements.

  • Serve as business lead on new product and material master management in the ERP system.

  • Exercise judgment within defined procedures and policies to determine appropriate action.

  • Acts as an advisor to a unit or sub-unit.

  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.

  • Perform other related duties as assigned to meet departmental and Company objectives.

  • Develop monthly and weekly end to end operations schedules in line with the agreed production plan from the production and capacity planning governance.

  • Timely release of monthly and weekly production schedule in co-ordination with supply chain, production, quality assurance, quality control, maintenance and R&D teams.

  • Maintain reports and key supply metrics, adjust production schedule as required.

  • Plan and monitor release and movement of bulk and finished goods in co-operation with warehouse personnel to support production schedule requirement.

  • Assist in identifying manufacturing and packaging batch record requirements.

  • Co-ordinate with Contract packaging organizations for monthly schedules and deliverables.

  • Lead weekly scheduling meetings to evaluate schedule adherence and coordinate any schedule change with all departments to firm up upcoming week's schedule.

  • Support Supply Chain lead preparing for Operation and management governance.

  • Monitor alignment of the schedule with the plan and commitments to the customers.

KNOWLEDGE/SKILLS/ABILITIES

  • Working knowledge of standard planning, production practices and capacity analysis.

  • Effective interpersonal skills, to include negotiation and conflict resolution.

  • Meticulous in following verbal and written instructions.

  • Accurate and precise in recording information.

  • Effective oral and written communication skills.

  • PC proficiency using Microsoft Office suite.

  • Ability to handle multiple tasks and challenges.

  • Ability to follow directives and procedures, along with ensuring compliance to the same.

  • Ability to understand the flow of production through the manufacturing plant

  • Ability to make decisions based on product need, personnel, and machine time.

  • Strong mathematical and analytical skills.

  • Ability to understand complex forecasting and inventory models.

EDUCATION/EXPERIENCE

  • Bachelor's degree; or equivalent combination of Associate's degree and pertinent, progressive experience with increasing levels of responsibility; preferably in pharmaceutical or other highly regulated industry.

  • Three years' pertinent experience in pharmaceutical or technical manufacturing environment.

  • Experienced in the use of MRP, inventory management, and purchasing systems.

  • Professional certifications, such as APICS, CPM, CPIM, CPP, and/or CPSM are preferred.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  • Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.

  • Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

  • Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  • Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.

  • Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.

  • Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.

  • Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

SUMMARY

Provide formulation/process development/scale-up expertise for the development of immediate release and extended-release oral solid dosage forms. Perform scale-up for oral solid dosage forms. Provide support to product lifecycle development and ongoing efforts for process improvements. Write experimental protocols, and assist in equipment set-up and the manufacture of pilot /manufacturing scale batches. Execute experimental protocols, assist in sample collection and submission for testing, and perform physical tests as required. Write and issue protocol summary reports and assist in Technology Transfer of products from Development to Operations. Provide support to Quality Assurance and Operations with respect to major process/product problems. Initiate and monitor stability studies pertaining to new product development.

ESSENTIAL Duties and Responsibilities

  • Support Quality by Design (QbD) efforts for the reintroduction of previously approved and manufactured products and new products.

  • Write experimental protocols and protocol summary reports.

  • Assist in equipment set-up and manufacture of pilot/manufacturing scale batches.

  • Write development Master Batch Records and development Master Packaging Records.

  • Provide input and support to Formulations Group in prototype, scale-up and exhibit batch manufacture.

  • Provide input and assistance to Operations and Quality Assurance Validation in the scale-up, validation and launch for the reintroduction of previously approved and manufactured products, and new products.

  • Provide input and assistance to Quality Assurance and Operations for major process/product problems. Carry out experimental studies to support vendor qualification efforts.

  • Recommend and justify the purchase of new equipment for Research & Development. Assist Engineering in the Installation and Qualification of Research & Development equipment

  • Establish/maintain outside contacts for information exchange regarding manufacturing technologies, theories and developments.

  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.

  • Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

  • Thorough knowledge of Pharmaceutical Technology and Pharmacy, Chemistry and/or Chemical Engineering.

  • Demonstrated and applied knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate and extended -release oral solid dosage forms.

  • Broad knowledge of development and manufacturing procedures gained through education and experience.

  • Thorough knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.

  • Good communication and analysis skills.

  • PC proficiency using Microsoft Office.

Education/Experience

  • Bachelor's degree in pharmacy, chemistry or chemical engineering.

  • Five years' experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of immediate and extended-release oral solid dosage forms.

  • Experience with dry blending, wet granulation, compression and tablet film coating, and powder encapsulation required.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  • Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.

  • Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

  • Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  • Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.

  • Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.

  • Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.

  • Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

We are an equal opportunity employer M/F/D/V.


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Supply Chain Specialist

Nesher Pharmaceuticals (Usa) LLC