Technical Services Scientist I
TECHNICAL SERVICES SCIENTIST I
This position is viewed as a technical resource in process development and/or daily commercial support. A Technical Services Scientist understands and applies technical principles, theories, and concepts in solid dosage manufacturing. The scientist will apply technical knowledge, creativity, and company practices under supervision and directions from the management to support the new process development through commercial launch, commercial manufacturing support throughout product life cycle, technology transfers and process improvement/optimization activities while meeting project time lines.
The scientist will identify and evaluate critical process parameters, conduct statistical analyses, and utilize experimental design techniques.
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 support up to 4 new and/or existing commercial drug products at various product lifecycle stages.
No P&L or budget 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 supervision and directions from the management.
- Performs scientific literature searches and evaluations as required.
- Provides analysis, evaluation and initial 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 (API’s) and excipients.
- Lead technicians and technical associates in conducting batch manufacturing and in-process sampling/testing.
- Provides off hour on-call support to manufacturing.
- Author/Review GMP documents (MBRs, PBRs, Validation protocols/reports) and generates change controls.
- Author/Review development documents (MBR, Protocols, Control Strategy Reports, Investigation/Assessment Reports).
- Assist with writing eCTD sections and justifications to support 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 information/data for internal meetings as deemed necessary.
- 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 assigned
- Bachelor’s Degree Required
- 0-4 years of pharmaceutical experience or appropriate degree in-lieu of experience.
- Experience in solid-dosage manufacturing is highly preferred: formulation/process development, commercial support, and/or technology transfer.
- Possesses facilitation skills and technical competence.
- Competent in English (both written and verbal). Technical writing skills with attention to detail and verbal/written communication skills. Able to generate 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 GMP concepts, and regulatory requirements (FDA, DEA, OSHA).
- 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.
- 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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