Sr Scientist - Process Development
5 - 7 years experience •
The Sr. Scientist -Technical Services coordinates activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation. Directs monitoring, investigations, engagement of scale-up or post approval changes to support existing products. Renders technical expertise and coordinates activities with PD for new product scale-up and manufacturing ANDA submission batches.Contributes to oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product lifecycle. Lead change requests for resolution of production issues and deviations to ensure supply and business continuity. Supports Continuous process monitoring. Participates in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions. Ability to investigate deviations to determine product impact. Design and conduct scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints. Understand and execute operation of pilot scale & commercial pharmaceutical manufacturing equipment without supervision. Duties will include the evaluation of formulation and process to determine their effects in relation to final product specification. This includes evaluating equipment set points and process parameters for their impacts on final product characteristics. Participation in formulation process evaluation early in the process development stage and participate in project risk assessments with Pharmaceutical Development and Operations. Independently design, plan and execute scale up and robustness evaluation of formulation processes. Responsible for identifying and executing projects to reduce product cost, improve product quality, improve yield, and reduce material usage.Collaborates with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability. Responsible for process technology training, SOP writing, technical reports and Validations. Provide training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment. Conducts evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes. Coordinates, executes and provides the transfer of technology to the manufacturing department during the process validation. Directly involved in successive phases of developmental and transfer activities including production of R&D/DOE, scale-up, registration, component changes and process validation batches in a cGMP environment. Support CMO products for off-site process validation activities including the monitoring/execution of validation batches, technical support for deviations, change controls and technical audits. May provide work direction and mentoring to junior-level Scientists.Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team.Tabulate and perform statistical analysis of all study data. Present conclusions with clear, logical, scientific explanations and justifications via technical report. Supportinternal, external and regulatory inspections including FDA, EMEA, and third party inspections. Provide technical consultation and support to both Technical Services and external departments as required.
A Bachelor’s degree in a scientific or technical field (chemistry, engineering, chemicalengineering, life science) and a minimum of 6+ years of experience working in the pharmaceutical industry OR Master’s degree in a scientific or technical field and a minimum of 4years’ experience working in the pharmaceutical industry. 2+ years experienceworking with solid oral dosage forms required. At least 2+ years of experienceworking with formulation process development, process scale up, technology transfer, or ongoing pharmaceutical commercial product support.
Other Knowledge, Skills and Abilities:
Knowledge and experience with FDA requirements for commercialized products and awareness of current industry technology and validation practices; demonstrated project management skills; Oversee the strategies and execution of cleaning validation and packaging validation test protocols and support documentation for these activities; Ability to conduct due diligence for products/processes and make recommendations; Understanding of stability programs and specification changes to approve protocols or JOS change controls; Assist in the execution of equipment qualifications as needed; Serve as the project manager for CCMS or other related projects; Maintain familiarity and complies with USL safety requirements. Conducts department or external department GMP training as required; Complete understanding and wide application of technical principle, theories and concepts in the field of pharmaceutical manufacturing and pharmaceutical formulation development; Provides technical solutions to a wide range of difficult problems; Works only under general direction. Independently determines and develops approach to solutions; Contributes to the completion of specific programs and projects; Frequent internal and outside customer contact. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Upsher-Smith Laboratories, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category. Job ID 7001