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 firstname.lastname@example.org to discuss our current open positions.
UPM offers competitive salaries and an excellent benefit package.
Current Open Positions at UPM Pharmaceuticals
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:
|Education: 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.|
Analytical Development Scientist (Pharma)
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
Minimum of Bachelor’s Degree in Chemistry or related science field and 4 years relevant experience including method development work (university internships do not meet this criteria). Additional years of non-method development work experience will be considered in determining qualification for the position. 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.
Manufacturing Quality Assurance Specialist
Essential Duties and Responsibilities
Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in real time during operations including:
- 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. Recommend product disposition from attribute evaluation.
- Leads or responds to quality audits when applicable to assure conformance with regulatory and internal requirements. Has the skill 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.
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.
Technical Services Process Scientist
- Responsible for technology transfer of solid dose products into Bristol site commercial manufacturing, site transfer of existing commercial products, and 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. Plan and conduct required pre-formulation and formulation stability studies, hold time studies, excipient compatibility studies, process development and optimization studies.
- Write experimental reports and product development reports to support 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, and capsules.
- 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, process development reports, investigation reports.
- Training and mentoring of new scientists and technical staff in product development, formulation, principles of experimental design.
Requirements: Master's degree in Chemistry, Pharmaceutics, or Industrial Pharmacy and three years of experience OR Bachelor's degree plus five years of experience in pharmaceutical solid dose formulation and process development. The position requires knowledge of pharmaceutical formulation, scale-up, technology transfer, process development, operation of solid-dose manufacturing equipment, investigations, and equipment and process validation.
Apply to email@example.com or fax to 423-989-8042, Gregory Pharmaceutical Holdings, Inc., 501 5th St., Bristol, TN 37620.