Technical Services Scientist

Manufacturing Process Development Expert

To provide expertise in the process development; scale-up and product transfer functions related to manufacturing operations at PAI

Duties and Responsibilities:

• 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.
• 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. This duty is performed weekly, about 50% of the time.
• Troubleshoot process and procedural issues during the manufacturing operations. This duty is performed weekly, about 50% of the time.
• Generate, edit and issue master batch documentation (MBRs) for process, equipment and cleaning activities. This duty is performed weekly, about 30% of the time.
• 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. This duty is performed weekly, about 30% of the time.
• 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. This duty is performed weekly, about 30% of the time.
• Lead and assist in demonstration/scale up/pilot batch manufacture, engineering studies, equipment upgrades, etc. This duty is performed weekly, about 30% of the time.
• Identify and suggest process, equipment and efficiency improvements in the operational area. This duty is performed weekly, about 20% of the time.
• Prepare and present training presentations for technical training of operations personnel. This duty is performed weekly, about 20% of the time.
• Review executed batch documentation as needed. This duty is performed weekly, about 10% of the time.
• Work in multi-functional teams (Validation, QA, QC, SCM) to enhance and facilitate overall operational success. This duty is performed weekly, about 50% of the time.
• Perform any other related duties as required or assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and Experience:

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. Oral liquid pharmaceutical experience preferred.

Communication Skills:

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.

Mathematical Skills:

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.

Critical Thinking Skills:

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.

About PAI Pharma:

PAI offers a broad portfolio of more than 60 prescription and over-the-counter therapies to treat patients. Some of our core strengths include brain, immune, metabolic and digestive health. For the OTC market, we provide a wide variety of affordable medications to treat allergies and upper respiratory symptoms, minor aches and pains, constipation and more.

To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities and government agencies, PAI offers standard bottle packaging and ready-to-dispense packaging. In fact, PAI was the first independent manufacturer to develop vertically-integrated unit dose (UD) packaging, and the first to offer complete lines of hard-to-find liquid products in both out-patient and UD packaging.

Additional Information:

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

PAI uses E-Verify.

EEO Employer / Veteran / Disabled