Technical Services Scientist III

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Technical Services Scientist IIIJob Summary:This position is viewed as a technical resource in process development and/or daily commercial support. A Technical Services Scientist applies a thorough understanding of technical principles, theories, and concepts in solid dosage manufacturing. The scientist will apply technical knowledge, creativity, and company practices with limited supervision and directions from the management supporting the new process development through commercial launch, commercial manufacturing support throughout product life cycle, technology transfers and process improvement/optimization activities while meeting project timelines.The scientist will identify and evaluate critical process parameters, conduct statistical analyses, and utilize experimental design techniques and apply technical knowledge, creativity, and company practices to obtain solutions to complex problems while meeting project time lines.The scientist will work in partnership with Research & Development, 3rd party customers or Manufacturing at various stages of product lifecycle.Perform technology transfer, process development, commercial support, and related activities required to concurrently supportu00A0 up to 8 new and/or existing commercial drug products at various stages of product lifecycle.u00A0 No P&L or budget responsibilities.Responsibilities: Design and conduct studies for solid-dosage products (qualification of new equipment and new materials, process development/improvement/scale-up, and technology transfer) in compliance with established SOPs, FDA/ICH guidelines, DEA regulations and safety requirements with limited supervision and directions from the management. Performs scientific literature searches and evaluations as required. Provides analysis, evaluation and interpretation of varied data including technical assessments of products and manufacturing processes. Performs root cause analysis for product/process related investigations. Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions. Provide technical evaluation and/or batch execution for alternate source projects for Active Pharmaceutical Ingredients (APIu2019s) and excipients. Effectively leads technicians and technical associates in conducting batch manufacturing and in-process sampling/testing. Provides off hour on-call support to manufacturing. Works with Engineering to design new equipment/process requirements.Author/Review GMP documents (MBRs, PBRs, Validation protocols/reports, SOPs) and generates change controls.Author technical assessments for required standalone data analysisDevelop and author statistical justifications/rationalAuthor/Review development documents (MBR, Protocols, Control Strategy Reports, and Investigation/Assessment Reports).Write eCTD sections and provide written justifications and answers to complete response letters and information requests from agencies.Ensure all documents are maintained in a complete and orderly manner.Maintain integrity of records, documents, and data at all times.Follow company policies as outlined in the employee handbook. Provide technical assistance to Validation in identifying critical process parameters. Assist the Manufacturing, Validation, Compliance and Regulatory Affairs groups with technical input. Collaborate with cross-functional groups within the site to achieve project goals and meet the timelines. Prepares and presents data and recommendations at internal meetings. Able to lead effective cross-functional meetings when deemed necessary.Take personal responsibility for defining, communicating, and implementing decisions with limited direction from management in support of project objectives.Provide guidance and necessary training for manufacturing personnel for new/optimized processes/products. Provide timely effective resolution to manufacturing problems of a technical nature. Other duties as assignedEducation/Qualifications: Bacheloru2019s degree in Science, Engineering, or Pharmaceutics. 7 u2013 12 years of pharmaceutical solid dosage manufacturing experience: formulation/process development, commercial support, and/or technology transfer.Possesses project management and facilitation skills and technical competence.Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills.u00A0 Able to generate high quality technical documentation (Protocols, Reports, MBRs, etc.).Proficiency with MS Office. Knowledge of data management systems (Master Control, SAP, etc.) commensurate with job expectations are preferred.Understanding of pharmaceutical manufacturing concepts.u00A0 Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA).Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques.Demonstrate adherence to company policies/procedures, compliance/regulatory mandates and quality requirements.Team Player with great communication skills. Able to lead effective cross-functional meetings when deemed necessary. Business travel less than 5% anticipated Will be required to wear a variety of PPE (e.g. PAPR, loose and/or tight fitting respirators, etc.).

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