(423) 989-8000     info@upm-inc.com

Professional Careers

UPM is a service organization and our employees are our greatest asset. This is why we seek highly skilled and highly motivated individuals to become a part of our team. We look for people that share a passion for the pharmaceutical industry as well as for hard work, creativity, and growth. Our employees are devoted to our mission of rapidly advancing pharmaceutical technologies and products on behalf of our clients. At the same time, we work in an enriching environment, work as a team where initiative and performance is rewarded. If you share our commitment to teamwork, enjoy a challenge, and want to feel good about the work you do, please contact UPM at humanresources@upm-inc.com to discuss our current open positions.

UPM offers:

  • Health and Dental Insurance
  • Life/Disability Insurance
  • Competitive Salaries
  • 401k Program

QC Data Reviewer

Job Posted: 07-22-2016

UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a QC Data Reviewer.

Under the direction of QC Management, performs review of analytical data and calculations associated with but not limited to material testing and analytical method transfer, optimization, development and validation.  Performs these goals by reviewing raw data, chromatograms, reports and results sheets, calculations, notebooks and logbooks associated with testing and generation of results in accordance with laboratory SOPs.

Essential Duties and Responsibilities:

  • Performs review of analytical data and calculations associated with, but not limited to material testing, 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 and in accordance with laboratory SOPs.
  • Reviews documented laboratory activity and data filed in appropriate log books, records, files and equipment calibration logs.
  • Reviews maintenance/qualification data for laboratory equipment such as balances, pH-meters, HPLCs, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs.
  • Conducts peer reviews of other analytical chemists and scientists’ work prior to submission to quality assurance.
  • Reviews technical reports, protocols, final reports, stability reports and other forms of documentation as required. This will include the preparation and review of all data supporting regulatory filings, such as CMCs and NDAs; with the preparation, review, auditing and control of Methods Development documents including, but not limited to protocols, reports, laboratory notebooks, general practices, batch cards, test request, material specifications, certificates of analysis & compliance, and standard operating procedures; and to issue progress reports regarding the results and status of the review and audits of these documents.

Knowledge Necessary to Perform the Job:

  • Must possess a command of cGMP requirements as it applies to pharmaceutical analytical data for test samples, and demonstrate attention to detail.
  • Possess an understanding of cGMPs relating to documentation requirements for the final release of analytical test data.
  • Knowledge of Company laboratory SOPs, good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA and DEA regulations, and MSDSs essential.
  • Knowledge of the operation of modern analytical instrumentation and software.
  • Understanding of analytical method development/validation.
  • Must have strong scientific writing and reviewing experience.

Education:

Requires a BS in Chemistry or related scientific field and minimum 1 – 3  years of pharmaceutical experience using analytical instrumentation and/or data review experience.  Knowledge of pharmaceutical GMP required.  Equivalent combination of education and experience or training is acceptable.

Please submit your resume and salary requirements to: humanresources@upm-inc.com 

EOE

 

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Label Associate I

Job Posted: 07-22-2016

UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a Label Associate I.

The Label Associate works daily in Label Office with the Label Control Supervisor to perform all job functions necessary to ensure that Printed Labeling is properly stored, inventoried and prepared for each batch to be packaged.  Assembles and stages Mobile Security Cages stocked with batch specific labeling components for all scheduled orders.  Monitors and adjusts the staging and issuance of labeling to accommodate schedule changes as needed.  Using company designated computers, printers and software, the associate prints serialized barcode container, carton and case labels, and sets up case label printers on packaging lines (when applicable) for commercial products.  The Associate ensures that all Label Control Limited Access Areas are properly and carefully maintained in keeping with CGMP standards and SOPs.

Essential Duties and Responsibilities:

  • Operates Label Counting and Rewinding Equipment, Zebra and Page Printers, Scanners and other equipment used for production and inventory of printed labeling materials.
  • Stages, issues, and reconciles printed components for each batch of product to be packaged.
  • Creates new label formats with approved company software and computers for container, carton and shipper labels as necessary to comply with Global Serialization Standards for Commercial Pharmaceutical products.
  • Communicates problems, concerns and solutions in a clear and appropriate manner to Supervision to minimize bottle necks and prevent investigations. Must be able to read, analyze and interpret CGMPs, SOPs, Pick Lists, Equipment Manuals, Schedules and Batch Records.
  • Maintains labeling inventories through manual stock counts and meticulous record keeping.
  • Transports approved materials to and from Label Control Areas and Packaging Department for use and storage as needed.
  • Insures the accuracy of each item dispensed and the correct copy code for all labeling issued.
  • Assists in the developing of SOPs, standard ways of working, and Label Control processes.
  • Completes all assigned tasks and duties in a professional and timely manner.
  • Supports electronic document management processes on an as needed basis.

Education/Experience:

High School Diploma or GED required; Must have at least 1 year of Pharmaceutical documentation, inventory or warehouse experience.  An equivalent combination of education and experience is also acceptable.

Please submit your resume and salary requirements to: humanresources@upm-inc.com  

EOE

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Formulation Associate

Job Posted: 07-19-2016

UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a Formulation Associate.

Formulation Associate:  a hands-on support scientist role in pharmaceutical formulation and process development. Will have responsibility to support client projects in various product development and manufacturing activities within time and budget constraints.

Desired attributes include:  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.

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

EOE

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Vice President of Quality Control

Job Posted: 06-28-2016

UPM Pharmaceuticals, Inc., a mid-sized contract drug development and manufacturing company, located in Bristol, Tennessee is seeking a Vice President of Quality Control.   This position reports to the Senior Vice President of Quality Operations and will be located in Bristol, Tennessee.

Key Responsibilities:

  1. Develops, initiates, maintains and revises policies and procedures for assuring that the QC labs (analytical development, microbiology, release raw material and stability) all operate according to FDA and internal quality assurance policies.
  2. Oversees all quality control lab operations including the planning, coordination, and implementation efforts for compliance with all cGMPs, regulations, laws, and internal Standard Operating Procedures through audits, inspections, and training of personnel.
  3. Directs and supervises all employees in the Quality Control department; hires, plans, directs and assigns workload, conducts performance appraisals, makes promotional and salary increase recommendations, takes disciplinary action as needed and resolves personnel issues.
  4. Reviews all annual budget submissions and expenditure plans for the department, makes decisions regarding the use of financial resources allocated to the department.
  5. Develops and oversees the objectives and program to insure FDA and DEA regulatory compliance that results in receiving and maintaining the capability to conduct analytical testing of Phase I, II, III, clinical and commercial manufactured products.
  6. Develops approaches to solve problems identified during daily activities and for quality and agency audits.
  7. Serves as the management lead in dealing with all regulatory agency and client representatives regarding QC Operations.
  8. Recruits, hires and monitors the use of consultants in providing quality and regulatory services to the company.
  9. Prepare and review documentation for FDA and DEA submissions for UPM and its clients.
  10. Determines scheduling priorities and workload allocations to maintain company revenue targets and client timelines in accordance with protocols and SOPs.
  11. Ensures that the design of the process for analytical method transfer, optimization, development and validation of drug substances, drug product and cleaning residue testing is being conducted in accordance with UPM SOP using USP and ICH guidelines.
  12. Participates in laboratory investigations and assists in writing investigation reports.
  13. Provides and maintains trending and metrics data to include but not limited to analyst error rates, sample testing timelines, investigations and CAPA effectiveness

Knowledge Necessary to Perform the Job:

  • Strong knowledge of laboratory operations, good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA and DEA regulations, and MDSDs essential.
  • Knowledge of computer operations procedures essential.
  • Knowledge of the operation of modern analytical instrumentation and software, including Empower® Chromatography Software.
  • Knowledge of analytical method development/validation procedures.
  • Knowledge of fundamental concepts of analytical chemistry.

Education / Experience:

Master’s Degree with emphasis on Analytical Chemistry. 15-20 years in a laboratory setting.  10-12 years of management experience in a pharmaceutical environment required.  Prior work experience in pharmaceutical RD method development and validation laboratory preferred.

Qualified candidates please reference job title and email resume and salary requirements to: humanresources@upm-inc.com or fax: 423-989-8042.

EOE

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Technical Services Engineer

Job Posted: 04-21-2016

UPM Pharmaceuticals, Inc., (upm-inc.com) a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a Technical Services Engineer.

The role will be responsible for:

  • Execution of equipment / facility qualifications,
  • Assisting with the transfer of products either from internal or external development into the Bristol site;
  • Preparing protocols and reports to document technical for the transfer of products, qualifications, etc. to support Engineering activities.

Essential Duties and Responsibilities:

Reviews/Revises Master Batch Records for clinical/commercial production. Participates on teams transferring products to Bristol or between contract sites.  Evaluates and develops process improvements for manufacturing processes. Supports changes in scale of processes to Manufacturing size including equipment sizing, formulation and equipment compatibility. Prepares equipment equivalency report for regulatory filings and recommends equipment purchases for new processes and to improve existing processes. Prepares, reviews, edits and executes validation documents (IQ, OQ and PQ). Provides manufacturing input to project time-lines for product transfers. Works with QA, Validation, Engineering, Purchasing, Regulatory, R & D and Manufacturing on projects. Prepares suitable protocols and reports on rojects/activities. Partner with Manufacturing and Quality organizations in daily operations to ensure the process is maintained in a GMP compliant, reliable state of control.  Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc). Participate in and provide technical support and analysis for the resolution of deviations, investigations, and process issues. Generate documents (technical memos, reports, protocols, etc.) related to process monitoring program and non-conformances.

Qualifications:

Pharmaceutical experience is required.

BS in Industrial Pharmacy, Chemical, Engineering, Chemistry or a science related field with six to eight years’ of direct pharmaceutical experience; or equivalent combination of education and direct pharmaceutical experience. Knowledge of basic math, algebra, geometry, calculus and statistics. Thorough knowledge of cGMPs and internal SOPs. Knowledge of pharmaceutical formulations and scale up principles. Extensive knowledge of equipment used in pharmaceutical manufacturing and packaging. Knowledge of validation in pharmaceutical manufacturing and statistical analysis of processes.

Qualified candidates please submit your resume and salary requirements to:  humanresources@upm-inc.com

EOE

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Analytical Chemist

Job Posted: 03-16-2016

UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking an Analytical Chemist.

Under the direction of analytical services management, performs analytical method transfer, optimization, development, and validation.  Performs chemical testing following developmental protocols or approved methods, and participates in instrument validation.  Conducts experiments using wet chemistry and appropriate laboratory instruments, collecting and interpreting analytical data and writing reports in accordance with laboratory SOPs.

Essential Duties and Responsibilities:

Performs analytical method transfer, optimization, development, and conducts analytical methods validation of drug substances, drug product, and residual testing, using guidelines from USP and ICH.   Develops protocols under which the methods transfer, optimization development, and validation are conducted.  Evaluates statistically the validation data and writes the method validation report for submission.  Writes test methods into company SOPs; reviews, writes, or assists in writing SOPs for analytical development.  Performs USP 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.  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, GC, UV-Vis, and other analytical instrumentation.  Collates test results and prepares certificates of analysis and stability reports. Conducts peer review of other analytical chemists and scientists work, prior to submission to quality assurance.

Technical Skills – Ability to operate analytical balance, computer, HPLC, GC, UV/VIS Spectrophotometer, pH meter, FTIR, Karl Fischer Titrator, Automatic Titrator, Polarimeter, Specific Gravity Meter, and Melting Point Apparatus, and other modern analytical equipment.

Education/Experience:

Bachelor’s degree in Chemistry or related scientific field with at least 2 years of analytical chemical experience.  Pharmaceutical laboratory experience preferred.  Equivalent combination of education and experience or training is acceptable.

Computer Skills:

To perform this job successfully, an individual should have computer skills with knowledge of Word, Excel, Access, Outlook, and ability to use internet tools.

Please submit your resume and salary requirements to: humanresources@upm-inc.com or fax: 423-989-8042. EOE.

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Senior Scientist

Job Posted: 03-16-2016

UPM Pharmaceuticals, a Division of Gregory Pharmaceutical Holdings, Inc., (www.upm-inc.com) located in Bristol, Tennessee, is seeking a Senior Scientist that leads in the development of new analytical methods and mentors other analysts to develop their technical skills.

 Essential Duties and 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 USP 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.

Qualified candidates please reference job title and email resume and salary requirements to:

humanresources@upm-inc.com or fax: 423-989-8042. EOE.

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