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@example.com 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 Quality Assurance SpecialistJob Posted: 4-20-2017
UPM Pharmaceuticals, Inc., a mid-sized contract drug development and manufacturing company, located in Bristol, Tennessee is seeking a Manufacturing Quality Assurance Specialist.
- Assists and supports the manufacturing/packaging/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.
- Makes decisions of acceptability/rejectability of 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 referred by SQC . 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.
- Maintain a working knowledge of government and industry Quality standards.
Knowledge necessary to perform the job:
- 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, company business plan, validation plan and financial plan.
Education / Experience:
Bachelor's degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and six to eight years of related experience and/or training; or equivalent combination of education and experience. Pharmaceutical experience preferred.
Qualified candidates please reference job title and email resume and salary requirements to: firstname.lastname@example.org. EOE.
Analytical ChemistJob Posted: 12-01-2016
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.
Bachelor’s degree in Chemistry or related scientific field. At least two years of analytical chemical experience preferred. Pharmaceutical laboratory experience preferred. Equivalent combination of education and experience or training is acceptable.
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: email@example.com or fax: 423-989-8042.
EOE.Inquire about This Job >>
Technical Services Process ScientistJob Posted: 09-30-2016
UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a Technical Services Process Scientist.
The role will be responsible for:
- Scale-up, tech transfer, and process development of tablet and capsule products.
- Execution of equipment and facility qualifications and process validations.
- Process optimization, trouble-shooting, investigation, and support for commercial manufacturing.
- Writing manufacturing records, development plans, protocols, and reports for process development, equipment qualification, process validation, deviations, and investigations.
Essential Duties and Responsibilities:
Technology transfer of solid dose products into Bristol site commercial manufacturing. Site transfer of existing commercial products; scale-up and process development for new formulations. Prepare equipment equivalency reports for regulatory filings; recommend equipment purchases for new processes and to improve existing processes. Work with QA, Validation, Engineering, Purchasing, Regulatory, R & D, and Manufacturing on project teams. Write, review, and execute validation protocols (equipment IQ, OQ, and PQ; process validations). Provide technical support to Manufacturing for the resolution of deviations, investigations, and process issues. Perform process monitoring using statistical analysis. Evaluate and develop process improvements for manufacturing processes. Write Master Batch Records, development reports, investigation reports.
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. Essential skills are knowledge of solid-dose unit operations, problem-solving ability, technical writing, project management, and ability to learn on the job. Knowledge of cGMPs and internal SOPs. Knowledge of pharmaceutical formulations and scale-up principles. Extensive knowledge of tablet and capsule process equipment and unit operations. Knowledge of current FDA validation requirements. Experience with controlled substances is preferred. Experience with Wurster processing is preferred. Experience with formulation of tablets and capsules is preferred.
Qualified candidates please submit your resume and salary requirements to: firstname.lastname@example.orgInquire about This Job >>
Senior ScientistJob 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.
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:
email@example.com or fax: 423-989-8042. EOE.Inquire about This Job >>