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 [email protected] to discuss our current open positions.

UPM offers competitive salaries and an excellent benefit package.  To learn more, click here to download our Benefit Summary. 

Manufacturing Operator

Essential Duties and Responsibilities

Weighs and samples development and commercial manufacturing batches in accordance with applicable SOPs. Sets up, operates, breaks down and cleans equipment to be used in manufacturing activities in accordance with SOPs and equipment specifications. Performs scheduled manufacturing activities in accordance with approved batch records. Performs appropriate in-process tests of manufactured products during the manufacturing process. Provides appropriate documentation of manufacturing processes and test results including maintaining and reconciling equipment and room use log books, batch records, and inventory records in accordance with SOPs. Performs appropriate cleaning of equipment and the facility in accordance with SOPs and cGMP procedures. Troubleshoots equipment/processes during the manufacturing process. Performs other duties as assigned.

Education/Experience

Moderate knowledge of cGMP practices required. Moderate knowledge of operation of technical equipment required. Knowledge of processes related to the production of solid dose pharmaceutical manufacturing REQUIRED. Knowledge of process related to the production of liquid dose pharmaceutical manufacturing required. Knowledge of electronic data acquisitions systems to include ADP, Documentum, and FormWeigh. High School Diploma or GED required

Inquire about This Job >>

Analytical Development Chemist

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. 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. 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 analytical qualification studies. Consults with scientific professionals and scientific literature for problem solving assistance. Provides analytical testing support for manufacturing process validation. Observes safety rules and assists in keeping the laboratory a safe environment. Assists 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.

Education/Experience

Bachelor’s Degree in Chemistry or related science field and a minimum of 2 years of pharmaceutical experience. Knowledge of good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs.

Computer Skills:

Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools. Empower Chromatography software experience is highly desirable.

Inquire about This Job >>

QC Data Reviewer

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. 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.

Education/Experience

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. Knowledge of the operation of modern analytical instrumentation and software. Understanding of analytical method development/validation. Must have strong scientific writing and reviewing experience. 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.

Inquire about This Job >>

Vice President of Quality Control

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 Chief Operating Officer and will be located in Bristol, Tennessee.

Key Responsibilities:

  1. Manages a full service Quality Control Lab of approximately 60 employees, that perform raw materials, stability, product release, analytical method transfer / development, and micro services in a CDMO environment.
  2. 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.
  3. Oversees all quality control lab operations including the planning, coordination, and implementation efforts for all compliance with all cGMPs, regulations, laws, and internal Standard Operating Procedures through audits, inspections, and training of personnel.
  4. 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.
  5. Reviews all annual budget submissions and expenditure plans for the department, makes decisions regarding the use of financial resources allocated to the department.
  6. 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.
  7. Develops approaches to solve problems identified during daily activities and for quality and agency audits.
  8. Serves as the management lead in dealing with all regulatory agency and client representatives regarding QC Operations.
  9. Recruits, hires and monitors the use of consultants in providing quality and regulatory services to the company.
  10. Prepare and review documentation for FDA and DEA submissions for UPM and its clients.
  11. Determines scheduling priorities and workload allocations to maintain company revenue targets and client timelines in accordance with protocols and SOPs.
  12. 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.
  13. Participates in laboratory investigations and assists in writing investigation reports.
  14. 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:

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

Qualified candidates please reference job title and email resume and salary requirements to: [email protected] or fax: 423-989-8042.

EOE

Inquire about This Job >>

Chemist

Essential Duties and Responsibilities

Performs pre developed analytical methods on drug substances and products. Conducts residual testing using guidelines from USP and ICH. Assists in the development of protocols under which the methods transfer, optimization development, and validation are conducted. Writes test methods into company SOPs. Reviews, writes, or assists in writing SOPs for analytical development. Performs USP Compendia testing and other Compendia testing as required. Consults with scientific professionals and scientific literature for problem solving assistance. Provides analytical testing support for manufacturing. 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 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 reviews of other chemists and scientists work. Observes safety rules and assists in keeping the laboratory a safe environment. Able to operate analytical balance, HPLC, GC, UV/VIS Spectrophotometer, pH meter, FTIR, Karl Fischer Titrator, Automatic Titrator, Polarimeter, Specific Gravity Meter, 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 required. Equivalent combination of education and experience or training is acceptable. Knowledge of good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs. Empower Chromatography software experience is valuable

Inquire about This Job >>

Pharmaceutical Formulation Development Advisor/Guide

Essential Duties and Responsibilities

This role requires experience with the formulation and process development of pharmaceuticals. Assists scientists with project leadership experience in the development of pharmaceutical solid oral dosage form products and manufacturing processes. Will provide science & technology guidance in support of client projects in various product development and manufacturing activities within time and budget constraints. Guidance will be provided to all levels within R&D, Manufacturing, Business Development, Quality, and Executive Management. Major activities include contract proposal review, business development support, technical guidance for project leaders, and participation in design of formulations and manufacturing processes. Assists in the evaluation & implementation of new technology & equipment, attends team meetings, reviews documents, answers technical questions, and participates in discussions. Provides presence on manufacturing floor or lab during critical operations, writes technical reports, advises on procedural, document, and batch record questions; advises on registration and validation activities, and many other lesser activities.

Education/Experience

Pharmaceutical formulation development experience is required. Preference for CDMO (contract development and manufacturing operation) experience with solid oral dosage forms and a PhD, but not required. Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, or biochemistry required. Skilled in the science & art of pharmaceutical product development. Experience & knowledge of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, & GLP procedures. Knowledge of programs like TrackWise and Documentum; knowledge of contract development, concept product development, clinical phase 1, 2, and 3, biobatch, registration, and validation. Experienced with IND/NDA/ANDA, QBD, CPP, DOE, and RLD activities. Detail oriented, a self-starter, excellent organization & communication skills, able to handle multiple tasks involving various departments in a fast-paced environment. Effective interpersonal skills. Able to read, analyze, interpret, & write scientific documents and reports. The will & ability to achieve success.

Inquire about This Job >>

Formulation Associate

Essential Duties and Responsibilities

The Formulation Associate is 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.

Education/Experience

Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, and biochemistry. Skilled in the science & art of pharmaceutical product development, experienced & knowledgeable of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, and GLP. Detail oriented, a self-starter, excellent organization, great communication skills, able to handle multiple tasks involving various departments in a fast-paced environment, effective interpersonal skills, abile to read, analyze, interpret, & write scientific documents/reports.

Inquire about This Job >>