Description:
This position is viewed as a technical resource in process development and/or daily commercial support. A Technical Services Pr. Scientist applies a thorough understanding and a wide application of technical principles, theories, and concepts in solid dosage manufacturing. The scientist will apply and mentor Jr. Scientists in technical knowledge, creativity, and company practices to support the new process development through commercial launch, commercial manufacturing support through product lifecycle, technology transfers and process improvement/optimization activities while meeting project timelines.
A Pr. Scientist performs daily functions with minimum to no input from management and generates and drive implementation of novel ideas to improve systems and/or processes. The scientist will identify and evaluate critical process parameters, conduct statistical analyses, and utilize experimental design techniques, obtain solutions to complex problems.
The scientist will work in partnership with Research & Development, 3rd party customers or Manufacturing at various stages of product lifecycle.
Scope of Job - size of organization, P&L responsibility, budget responsibility
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Perform technology transfer, process development, commercial support, and related activities required to concurrently support up to 10-plus new and/or existing commercial drug products at various stages of product lifecycle.
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No P&L or budget responsibilities.
Accountability & Responsibilities
Technology Transfer, Process Development, and/or Commercial Support
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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.
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Performs scientific literature searches and evaluations as required.
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Provides analysis, evaluation and initial interpretation of varied data including technical assessments of products and manufacturing processes.
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Performs root cause analysis for product/process related investigations. Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions.
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Provide technical evaluation and/or batch execution for alternate source projects for Active Pharmaceutical Ingredients (API’s) and excipients.
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Effectively leads technicians and technical associates in conducting batch manufacturing and in-process sampling/testing.
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Provides off hour on-call support to manufacturing.
Documentation
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Author/Review GMP documents (MBRs, PBRs, Validation protocols/reports, SOPs) and generates change controls.
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Author/Review development documents (MBR, Protocols, Control Strategy Reports, and Investigation/Assessment Reports).
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Write eCTD sections and provide written justifications and answers to complete response letters and information requests from agencies.
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Ensure all documents are maintained in a complete and orderly manner.
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Maintain integrity of records, documents, and data at all times.
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Follow company policies as outlined in the employee handbook.
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Author technical assessments for required standalone data analysis and present to upper management
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Author statistical rational with proper tools applied
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Review eCTD sections for accuracy and data integrity
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Approve documentation in managers absence
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Attend meetings and speak on behalf of manager in their absence
Other
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Provide Validation critical process parameters.
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Provide Manufacturing, Validation, Compliance and Regulatory Affairs groups with technical input.
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Collaborate with cross-functional groups across the network to achieve project goals and meet the timelines.
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Prepares and presents data and recommendations at internal and cross-site meetings.
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Lead effective cross-functional meetings.
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Takes personal responsibility for defining, communicating, and implementing decisions in support of project objectives.
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Motivate and improve the performance of others through mentoring. Review the work of lower-level technical staff.
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Identify and lead department initiatives to build or optimize internal systems.
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Provide guidance and necessary training for manufacturing personnel for new/optimized processes/products.
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Provide timely effective resolution to manufacturing problems of a technical nature.
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Mentor Jr. Scientists and act/fill in for lead in absence
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Other duties as assigned
Requirements:
Work experience (type of industry and years of experience) and certifications required for the job
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15+ years pharmaceutical manufacturing experience in solid-dosage formulation/process development, manufacturing support, scale-up, and technology transfer.
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Bachelor’s or advanced degree in Science, Engineering, or Pharmaceutics
Specific Skills
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Possesses project management and facilitation skills and technical competence.
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Competent in English (both written and verbal). Excellent technical writing skills with attention to detail and verbal/written communication skills. Able to generate high quality technical documentation (Protocols, Reports, MBRs, etc.).
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Proficiency with MS Office. Knowledge of data management systems (Master Control, SAP, etc.) commensurate with job expectations are preferred.
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Strong understanding of pharmaceutical solid dose manufacturing concepts. Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA).
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Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques.
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Demonstrate adherence to company policies/procedures, compliance/regulatory mandates and quality requirements.
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Team Player with great communication skills. Able to lead effective cross-functional meetings when deemed necessary.
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Ability to cross boundaries and sites
Physical Requirements
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Business travel less than 5% anticipated
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Will be required to wear a variety of PPE (e.g. PAPR, loose and/or tight fitting respirators, etc.).
