UPM Pharmaceuticals Seeking to Fill 8 Positions

Qualified candidates please reference job title and email resume and salary requirements to:humanresources@upm-inc.com

UPM Pharmaceuticals, Inc. (www.upm-inc.com), a growing contract drug development and manufacturing company, located at Bristol TN, is seeking applicants for the following 8 positions.

​

Formulation Associate

Desired Attributes

-Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, and biochemistry

-Skill in the science & art of pharmaceutical product development

-Experience & knowledge of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, & GLP

-Knowledge of programs like Outlook, Word, Excel, and Access

-Detail oriented, a self-starter, excellent organization & communication skills

-Ability to handle multiple tasks involving various departments in a fast-paced environment

-Effective interpersonal skills; ability to read, analyze, interpret, & write scientific documents/reports

-The will & ability to achieve success.

GMP Training Manager

Essential Duties & Responsibilities

Manage the development and administration of the training processes and systems to enable UPM to maintain compliance with all GMP training requirements. Collect, analyze and report on training key performance indicators for the training program and control and maintain inventory over the storage and movement of personnel training records in compliance with regulatory and internal record retention policies. Assess the training needs (metrics, surveys, interviews) to develop and deliver appropriate training on current GMP topics as well as Quality Systems tools and methodologies. Administer Train-the Trainer program and support regulatory inspections and audits.

Qualifications

-Education/Experience: BS/BA degree in scientific, education or teaching discipline.

-Minimum of 5 years experience in relevant pharmaceutical industry, Quality Assurance, and/or GMP training experience.

-Must have strong understanding of Quality Systems and cGMP.

-Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools.

Pharmaceutical Tech Engineer

Essential Duties & Responsibilities

Design testing methods and test finished products or process capabilities to establish standards or validate process requirements. Communicate manufacturing capabilities production schedules or other information to facilitate production process. Identify opportunities or implement changes to improve products or reduce cost using knowledge of fabrication processes, tooling and production equipment, assembly methods, quality control standards or product design, materials and parts. Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability or cost-effectiveness. Incorporate new methods and processes to improve existing operations. Prepare technical reports, data summary documents, or research articles for regulatory submissions or patent applications. Implement FDA regulations, validation assurance (VA) quality control and maintain Good Manufacturing Principles (GMP) within the facility.

Qualifications

-Education/Experience: Minimum education requirements; Bachelor’s of Science.

-Knowledge of the practical application of engineering science and technology to include applying principles, techniques, procedures and equipment to the design and production of various goods.

-Knowledge of raw materials, production processes, quality control, costs and other techniques for maximizing the effective manufacture and distribution of goods.

-Knowledge of design techniques, tools and principles involved in production of precision technical plan, blueprints, drawings and models.

-Knowledge of machines and tools, including their designs, uses, repair and maintenance

-Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools.

Production Planner

Essential Duties & Responsibilities

Implements production planning policies and procedures. Prepares production schedules for manufacturing and ensures that the consensus plan is effectively communicated both within all business units (Manufacturing, Analytical, Project Management) ensuring that company objectives are met for customer satisfaction and business revenues. Enters specific sales orders into the master schedule based on requested customer delivery dates, availability of raw materials and equipment. Monitors process work from start to finish ensuring on time execution to process timelines. Evaluates forecasts and net demand to determine production requirements and scheduling deadlines. Communicates operations that delay schedules and alters schedules to meet unforeseen conditions under the direction of the VP of Manufacturing. Communicates with various internal units and resolves concerns regarding schedules, orders, and special needs. Generates and publishes daily/weekly/monthly reports on production and supply performance. Advises management of the status of work in progress, material availability, capacity load and potential manufacturing constraint and prepares production reports. Assesses capacity bottleneck and ensures appropriate available capacities & capability to meet customer service requirements. Summarizes labor hours and material dollar costs on each job to prepare workforce projections and budget estimates in order to meet accounting requirements. Assists in price quoting potential work.

Qualifications

-Minimum of a Bachelor Degree in a business related area, Logistics, Engineering or equivalent is required.

-Minimum of 3 yrs. experience in a manufacturing environment is preferred.

-Experience in Supply Chain Management, Logistics or Industrial Engineering is preferred.

-Excellent written and verbal communications skills are required.

-Experience in planning, scheduling, capacity analysis, capacity planning, production and materials scheduling is preferred.

-Proficiency in Microsoft Office and Advanced Excel knowledge are required.

-Experience with a computerized production planning system preferred.

-Demonstrated ability to balance multiple projects and priorities at the same time is preferred.

-Experience with Quality and Document Management Systems is preferred.

-Knowledge of planning systems and/or similar systems to forecast demand, plan inventory and production planning.

-Strong analytical skills with capability to query systems in order to extract sets of data for analysis required.

Project Leader

Desired Attributes

-Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, and biochemistry

-Skill in the science & art of pharmaceutical product development

-Experience & knowledge of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, & GLP

-Knowledge of programs like Outlook, Word, Excel, and Access

-Detail oriented, a self-starter, excellent organization & communication skills

-Ability to handle multiple tasks involving various departments in a fast-paced environment

-Effective interpersonal skills; ability to read, analyze, interpret, & write scientific documents/reports

-The will & ability to achieve success.

Quality Associate

Essential Duties & Responsibilities

Assists and supports the manufacturing, packaging, and laboratory staff in detecting and solving compliance errors in real time during operations. Evaluates deviations through notice of event reports and investigations; assigns and communicates corrective and preventative actions (CAPA) to responsible departments; provides follow-up on CAPA and assesses effectiveness of CAPA. Assign disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards, and company specifications. This activity provides authorization for the transfer or use of product or components at significant evaluation points in the manufacturing process and ultimately for the release to distribution. It involves review of the batch record for the completeness and accuracy of entries, adequacy of investigation of deviations and conformance to test results with the established standards. Review investigations from operations and the laboratory. Evaluate and approve in-process data in accordance with the established specifications to measure conformance of final container contents to label claim. Make decisions concerning out of limits or out of trend in-process situations. Determine need, schedule, prepare protocols, and evaluate attribute inspections associated with batch deviations. Evaluate attribute failures. Recommend product disposition from attribute evaluation. Leads or responds to quality audits when applicable to assure conformance with regulatory and internal requirements. Has the skills necessary to conduct own internal audits. Participates in and provides leadership for Projects as designated by upper management. Revises, evaluates, and approves SOPs, as necessary. Compile Annual Product Reviews for the commercial market, and evaluate stability data and trends; identify any preventative or corrective actions that would lead to product quality improvements and report them to upper management. Participate in customer complaint investigations, as necessary and maintain a working knowledge of government and industry Quality standards.

Qualifications

-Education/Experience: Bachelor’s degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and four to eight years of related experience and /or training; or equivalent combination of education and experience.

-A thorough understanding of 21 CFR 210 and 211 cGMPs and prior experience in regulated industry and knowledge or expertise in cGMP manufacturing or quality control is preferred.

-Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to us internet tools.

Quality Assurance Auditor

Essential Duties & Responsibilities

Proficient in the manufacturing operations and quality procedures for the area (s) to facilitate compliance to regulations. Participates in, or conducts, quality audits when applicable to assure conformance with regulatory and internal requirements. Participates in supplier qualification program and audits suppliers as necessary. Assists and supports the manufacturing/packaging/laboratory staff in detecting and solving compliance errors in real time during operations. Participates in understanding failures and resulting corrective and preventative actions (CAPAs) through notice of event reports. Participates in batch record review for compliance to the current Good Manufacturing Practices, compendia standards, and company specifications. It involves review of the batch record for the completeness and accuracy of entries, adequacy of investigation of deviations and conformance to test results with the established standards. Evaluate and approve in-process data in accordance with the established specifications to measure conformance of final container contents to label claim. Reports to management any observed NOEs for procedural deviations. Coordinates and maintains the stability studies.

Qualifications

-Education/Experience: Bachelor’s Degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and 0-4 years of related experience and/or training; or equivalent combination of education and experience.

-Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine disposition of product batches and raw materials.

-Knowledge of manufacturing and laboratory operations.

-Also, should possess basic computer skills with knowledge of Word, Excel, Access,
Outlook and the ability to use internet tools.

Senior Scientist

Essential Duties & Responsibilities

Performs analytical method transfer, optimization, and development/validation design and analytical methods development/validation of drug substances, drug product and residual testing, using guidelines from USP and ICH. Plays a lead role in the development of new methods. Develops protocols under which the methods transfer, optimization, and development are conducted. Evaluates statistically the validation data and writes the method validation report for submission. Writes, edits, and revises test methods and procedures into company SOPs; reviews, writes, or assists in writing SOPs for analytical development. Participates in the planning and execution of raw material, components, and vendor qualification or alternate supplier qualification studies. Participates in laboratory investigations and assists in writing investigation reports. Performs US Compendial testing and other Compendial testing as required. Consults with scientific professionals and scientific literature for problem solving assistance. Provides analytical testing support for manufacturing process validation. Documents laboratory activity and files all data using appropriate log books, records, files, and equipment calibration logs. Observes safety rules and assists in keeping the laboratory a safe environment. Operates laboratory equipment such as balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs. Performs routine sample processing and dosage form analysis using HPLC, Dissolution and UV-Vis analysis equipment. Performs routine maintenance, calibration, and performance verification on applicable instruments. Conducts peer reviews of other analytical chemists and scientist’s work prior to submission to quality assurance. Maintains professional and scientific competence in analytical chemistry by reading scientific literature and/or attending seminars, training sessions, workshops or classes.

Qualifications

-Education/Experience: Bachelor’s degree in Chemistry or related scientific field with at least 8 years of analytical chemistry experience. Advanced degree preferred.

-Pharmaceutical laboratory experience in analytical methods development and validation is required.

-Equivalent combination of education and experience or training is acceptable.

-Knowledge of company laboratory SOPs, good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs essential.

-Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools.