Technical Services Scientist

PAI Holdings LLC•Greenville, SC

7h•Onsite

About The Position

To provide expertise in the process development; scale-up and product transfer functions related to manufacturing operations at PAI. This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPs, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time. To provide overall support in the safe and compliant manufacture of commercial pharmaceutical products. This duty is performed daily, about 100% of the time.

Requirements

Four year technical degree (I.E. bachelors) or equivalent experience required. In such fields such as engineering, science (Chemistry, Biology), etc, plus 7 years Pharmaceutical manufacturing experience and/or training. Or equivalent combination of education and experience.
Ability to read, analyze, and understand common scientific and technical journals, financial reports, and legal documents.
Ability to respond to complex or difficult inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Nice To Haves

Oral liquid pharmaceutical experience preferred.

Responsibilities

Define and assist in the development of manufacturing processes of pharmaceutical products. This includes process scale-up, product transfer, new product development and existing product and process improvement.
Troubleshoot process and procedural issues during the manufacturing operations.
Generate, edit and issue master batch documentation (MBRs) for process, equipment and cleaning activities.
Investigate deviations and variances in both manufacturing and packaging. Generate deviation reports and identify long term corrective and preventative actions. Assure implementation of such solutions in a timely manner.
Lead and assist in all technical process enhancements and ancillary activities such as but not limited to: Process and equipment validation, implementation of new equipment, changes to existing manufacturing process, etc.
Lead and assist in demonstration/scale up/pilot batch manufacture, engineering studies, equipment upgrades, etc.
Identify and suggest process, equipment and efficiency improvements in the operational area.
Prepare and present training presentations for technical training of operations personnel.
Review executed batch documentation as needed.
Work in multi-functional teams (Validation, QA, QC, SCM) to enhance and facilitate overall operational success.
Perform any other related duties as required or assigned.