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.  To learn more, click here to download our Benefit Summary. 

Commercial Project Manager

Essential Duties and Responsibilities

Leadership abilities in dealing with details around commercial production (ex: materials, documentation, scheduling, etc.) as well as administrative requirements for tracking KPI's and deliverables. In addition both oral and written skills are required for leading meetings (internal, external, and joint) which would include: scheduling, preparing agendas, collecting and issuing minutes, defining and tracking actions, etc. Interacts with clients in problem solving and status meetings.

Internal requirements include ability to work with others, understanding technical requirements of material receipt, manufacture, test and release as well as GMP requirements for commercial production. Reviews and acts as liaison for manufacturing and packaging batch records, analytical documents, release documents and NOP's concerning commercial manufacturing operations. Assists sales staff in estimating costs and timelines associated with product changes (outside of commercial supply agreement). Provides relevant financial data on the project to the Finance Department to assist in appropriate revenue recognition and client invoicing activities

Key attributes required

  • Management, Organization and Communication Skills
  • Lab Knowledge
  • Technical Manufacturing Knowledge
  • Team Leadership
  • Independent Thinking
  • Decision Making
  • Knowledge of Commercial GMP Requirements
  • Prepares, monitors, and updates product timelines
  • Ability to multi-tasks is essential

Education/Experience

Applicable Bachelors in Business, Science or Engineering degree or related scientific field with at least 5 years of pharmaceutical related commercial manufacture experience. Equivalent combination of education and experience or training is acceptable. Five (5) years of supervised project coordination and management experience, both internal and external preferred.

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Chemist

Essential Duties and Responsibilities

The Pharmaceutical Chemist performs set up, calibration, operation, and maintenance of laboratory test equipment. Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements. Adheres to cGMP, which include, but is not limited to, proper laboratory documentation and maintenance, and archiving of paperwork. Compiles reports of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment, and reagents used in analytical testing. Develops proficient practical laboratory skills, a thorough knowledge of chemistry theories, analytical techniques, and adopts site procedures as required. Assists in the execution of protocols, method transfers, and validation studies under the guidance of more experienced analysts. May need training in the handling of controlled substances. The Pharmaceutical Chemist performs routine and non-routine quality control testing of raw materials, in process, residual, finished product, and stability testing within the framework of the site policies and cGMP regulations. Participates in special studies to accomplish company and departmental goals. Records and reports data accurately and in compliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP. Performs duties under the guidance of laboratory management or designee.

Education/Experience

Bachelor’s Degree in Chemistry or related science field is required with 2 years of pharmaceutical experience in a professional setting is preferred (university internships do not meet this criteria).

Computer Skills

To perform this job successfully, an individual should have competent computer skills including knowledge of Word, Excel, Access, Outlook, and ability to use internet tools. Empower Chromatography software experience is highly desirable.

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Director of Analytical Development, Quality Control

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

Essential Duties and Responsibilities

  1. Provides leadership and supervision to a talented and diverse group of scientists responsible for analytical method development, method transfer, optimization and method validation services. Responsibilities additionally include carrying out management duties, in accordance with company policies, such as hiring support, mentoring, assignment of work duties, directing work, appraising performance and disciplinary evaluation.
  2. Lead laboratory investigations, deviations, CAPAs and change controls related to the analytical development group. Serve as expert reviewer of generated reports.
  3. Performs analytical method transfer, optimization, and development/validation design for analytical methods development/validation of drug substances, drug product, and cleaning residue testing, using guidelines from USP and ICH.
  4. Review laboratory analytical protocols and reports for accuracy and compliance with company SOPs, USP, ICH, and cGMP guidelines, as required, prior to submission for approval.
  5. Periodically reviews laboratory equipment qualifications, method validation protocols and executed protocol reports for accuracy and compliance with cGMP, GLP and company SOPs.
  6. Provide GDP, GLP, and cGMP training to personnel and enforces compliance, as applicable, of the same.
  7. Author and/or review company Standard Operating Procedures (SOPs) as related to the analytical development group.
  8. Develops and maintains professional and scientific competencies for self and within group by mentoring, seminar attendance, workshops and classes.
  9. Responsible for high level analytical representation for client business development. Additionally, required to be a subject matter expert in support of development group and client interactions.
  10. Enforces compliance with all safety and environmental requirements associated with laboratory activities.

Knowledge Necessary to Perform the Job

  1. Expert knowledge of FDA regulations 21 CFR Part 210 & 211, OSHA, EU, JP, USP, and ICH.
  2. Expert knowledge of oral dose and semi-solid manufacturing processes essential.
  3. Knowledge of QC inspection and QC lab processes are essential.
  4. Advanced knowledge of analytical test methods are required (HPLC, dissolution, content uniformity, etc.)
  5. Extensive knowledge of analytical method validation requirements.
  6. Knowledge of computer operations essential.

Education/Experience

Bachelor’s Degree in Chemistry, Engineering or related scientific field. Advanced degree and leadership experience is highly desirable. Minimum of 8 years’ experience in Quality Control management in a GMP pharmaceutical manufacturing environment required. Equivalent combination of education and experience or training is acceptable.

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Analytical Development Scientist

UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking an Analytical Development Scientist that leads in the development of new analytical methods.

Essential Duties and Responsibilities

  • Transfers or develops & validates analytical methods including requisite method protocols, optimization and technical reporting for APIs, drug products, excipients, and raw materials
  • Assists with or develops Standard Operating Procedures, robust Quality Control testing methods/procedures and coordinates transfer of methods into Quality Control group
  • Participates in the planning and execution of raw material, components, and vendor qualification or alternate supplier analytical qualification studies.
  • Critical scientific/technical data analysis and presentation including analytical development representation on customer-focused project teams, as appropriate
  • Often assists with drug product, stability and residual testing under applicable regulations (e.g. ICH, FDA, EMA) or analytical testing for manufacturing process validation
  • Stays up-to-date on current research literature, industry practice and applicable regulatory requirements
  • Assists routine maintenance, calibration, and performance verification on applicable instruments
  • Complies with all applicable policies regarding health, safety and environment

Education/Experience

Bachelor’s Degree in Chemistry or related science field and a minimum of 2 years relevant experience including method development (university internships do not meet this criteria). Knowledge of good laboratory practices, cGMP, USP methodology, FDA, ICH, OSHA, DEA regulations, and MSDSs are desired.

Qualifications and Skills

Technical Knowledge – Strong theoretical and practical knowledge of analytical method development under cGMP regulated processes. Experience with HPLC, GC, UV/VIS, wet chemistry and USP/NF compendial methods are highly desirable. Experience with Empower chromatography software is a major bonus.

Computer Skills – Familiar with MS Office applications and data analysis software.

Communication – Strong interpersonal skills with excellent oral and written communication skill is required.

Adaptability – Ability to think critically and creatively in a highly dynamic environment to solve serious scientific problems. Effectively manages competing demands; able to deal with unexpected delays or events.

Dependability – Perfect candidate must be highly self-motivated and organized with demonstrated ability to prioritize, manage and schedule work within a high performing, high throughput laboratory environment to meet project deadlines in a Quality fashion. Attention to detail is a must.

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