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 competitive salaries and an excellent benefit package.

 

Current Open Positions at UPM Pharmaceuticals (6 August 2019)

Chemist III
The role will be responsible for, but are not limited to:

•  Performs raw material, in process, residual, finished product, component, validation, stability and special testing per specification, procedures, protocols, and current Standard       Operating Procedures (SOPs).
•  Performs testing with a high degree of efficiency, reliability, and accuracy.
•  Prepares necessary solutions and standardizes volumetric solutions. Participates in standard qualifications.
•  Maintains accurate/concise records of test data, charts, graphs, chromatograms, etc. following approved procedures. Tabulates and reports results in timely manner and immediately reports analytical issues, questionable results and out of specification results to laboratory management.
•  Generally, tests products that require the use of instrumentation and may involve more complex analytical techniques.
•  Performs appropriate maintenance and calibrations on different types of laboratory equipment properly documenting actions.
•  Performs assigned work meeting deadlines as instructed.
•  Reviews work of other analysts, which may include approval of laboratory data.
•  Participates and may conduct laboratory investigations using knowledge gained to determine causes and/or appropriate corrective actions.
•  Provides leadership in training less experienced laboratory staff.
•  Provides leadership in departmental projects such as method transfers or instrument validations, carrying out the projects from planning to completion.
•  Promotes safety in the laboratory and works in a safe manner complying with all safety regulations.
•  Continues to learn industry regulations, is familiar with USP/NF and other pharmacopeias (as applicable), FDA and ICH guidelines to assure that changes to procedures and policies continue to be compliant.
•  Assists with the development of new approaches by identifying potential problems during quality testing and providing potential solutions.
•  May assist in scheduling and coordinating testing activities, manpower, and equipment to service testing requirements of production, material management, stability and other objectives of the laboratory.
•  May serve on company committees to investigate problems or update procedures or practices to meet objectives of the company.
•  May serve on corporate committees to harmonize procedures and practices.
•  Assists in responding to audit observations.
•  Maintains professional and scientific competency in analytical chemistry by reading scientific literature and/or attending seminars, training sessions, workshops, or classes.
•  Employee should be trained in the handling of controlled substances.

Knowledge Necessary to Perform the Job:

Experience in analytical methods, laboratory instrumentation and techniques.
Possess fundamental concept of analytical chemistry, separation techniques, inorganic and organic chemistry principles.
Possess knowledge of USP/NF and other pharmacopeias (as applicable), cGMPs, FDA, and ICH regulations and guidelines, laboratory safety procedures, company policies and safety regulations.
Possess basic knowledge of computer programs such as instrumentation software and Microsoft office.

Education/Experience:

Bachelor’s Degree in Chemistry or related science field and 8 years of related experience; or an equivalent combination of education and experience/training; advanced degree in Chemistry or closely related field is desirable, but not required; pharmaceutical laboratory experience is required.

 

Product Development 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. 

Qualifications:

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.

 

 

Senior Product Development Scientist

The role will be responsible for:

  • Formulation of tablet, capsule, and semisolid products. 
  • 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.  Formulation of immediate and modified release tablet and capsule products by QBD principles to meet clinical and regulatory requirements for submissions to FDA.  Conduct required pre-formulation and formulation stability studies, hold time studies, excipient compatibility studies, process development and optimization studies.  Write experimental reports, product development reports, and required technical portions of client CTD filings and Response Letters.  Prepare equipment equivalency reports for regulatory filings; recommend equipment purchases for new processes and to improve existing processes.  Manufacturing experimental, clinical, registration, and validation batches of tablets, capsules, semisolids, and liquids.  Operating high shear mixers, mills, fluid bed dryers, V-blenders, bin blenders, roller compactors, tablet presses, encapsulators, Wurster particle coaters, tablet coaters.  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.  Training and mentoring of new scientists and technical staff in product development, formulation, principles of experimental design.  Support Business Development in responding to Requests for Proposals from clients, and in technical support for contract preparation.

Qualifications:

  • Essential Skills: Knowledge of solid-dose unit operations, problem-solving ability, technical writing, project management, 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.
  • Ability to strategize and develop project plans and timelines for development projects. Project management skills.
  • Experience with controlled substances is preferred. Experience with Wurster processing is preferred.  Experience with formulation of tablets and capsules is preferred.

Education / Experience:

Minimum education requirements: Masters degree in Chemistry, Pharmaceutics,  Industrial Pharmacy, or related discipline, and ten years of direct pharmaceutical industry experience; or Bachelors degree and more than fifteen years; or equivalent combination of education and direct pharmaceutical experience.

 

 

Pharmaceutical Facilities Engineer

This position will be responsible for engineering projects focused on the equipment, utility, and facility systems utilized in the solid and semi-solid operations at UPM Pharmaceuticals. This individual must have a background in mechanical engineering/HVAC/process utilities and a thorough understanding of engineering practice within FDA regulated industries. We are looking for a resourceful and goal-oriented individual who desires challenging work in a dynamic environment.

Essential Duties and Responsibilities:

  • Provide mechanical engineering services supporting projects from conceptual through detailed design, commissioning and qualification of pharmaceutical manufacturing facilities.
  • Interface with other designers and client representatives to supervise and coordinate the development of design deliverables.
  • Develop User Requirement Specifications for equipment, systems and utilities.
  • Develop equipment specifications, protocols and other design deliverables supporting facility capital expansions, renovations, new equipment and remediation projects.
  • Supply feasibility studies, concept development, safety/risk analysis, equipment/utilities capacity analysis and sizing.
  • Provide commissioning and troubleshooting support for equipment, facility and utility systems.
  • Identification, analysis and recommendation of state-of-the-art facility / utility / equipment alternatives to current site technology – that represent potential quality, cost and / or productivity improvements.
  • Directs and manages outside contractors for related engineering work.
  • Develops site / departmental Standard Operating Procedures (within the established quality system and change control process) as needed to address internal engineering programming criteria.
  • Participates in engineering, utilities and facilities qualifications as required.
  • Assists Director of Facilities Engineering and Maintenance in managing facility engineering capital project plans

Qualifications:

  • Bachelor’s degree in Chemical or Mechanical Engineering required.
  • Minimum 3 years of mechanical, electrical and plumbing (MEP) engineering experience required.
  • Process engineering experience a plus.
  • Minimum of 3 years’ experience in the design of FDA regulated facilities is required with an emphasis on pharmaceutical facility design is preferred.
  • Experience with managing and executing GMP projects by overseeing external design and construction management firms, plant utilities, clean utilities, clean rooms, airlocks and HVAC equipment is desirable.
  • Knowledge of applicable codes and standards required
  • Strong computer literacy, good written & verbal communication skills.
  • Moderate to good proficiency with Microsoft Project, Word, Excel, and AutoCAD
  • EIT or Registered P.E. is a plus

 

Manufacturing Operator

The Manufacturing Operator performs manufacturing processes of solid dose tablets and capsules, and liquid dose, in accordance with SOPs, approved batch records, and cGMP procedures.

Essential Duties and Responsibilities:

  1. Weighs and samples development and commercial manufacturing batches in accordance with applicable SOPs.
  2. Sets up, operates, breaks down and cleans equipment to be used in manufacturing activities in accordance with SOPs and equipment specifications.
  3. Performs scheduled manufacturing activities in accordance with approved batch records.
  4. Performs appropriate in-process tests of manufactured products during the manufacturing process.
  5. 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.
  6. Performs appropriate cleaning of equipment and the facility in accordance with SOPs and cGMP procedures.
  7. Troubleshoots equipment/processes during the manufacturing process.
  8. Performs other duties as assigned.

Knowledge Necessary to Perform the Job:

  • 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.

Education/Experience:

High School Diploma or GED required.

 

To apply, send resume and salary requirements to: humanresources@upm-inc.com
EOE