Position Summary Sr. Scientist:
Perform formulation and process development studies, scale-up processes in support of ANDA filings, and train technicians in the same. Prepare submission batches in a regulated manufacturing environment.
Responsibilities: Responsibilities include, but are not limited to:
· Through understanding of solid dose product development and manufacturing scale-up
· Operate as the subject matter expert (SME) on formulation and process development.
· Work on the Products range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
· Review and analyze relevant development data a from lab-scale, Exhibit-scale and commercial-scale
· Lead and/or participate in activities related to process development, Exhibit batch manufacturing, process verification/qualification, process pre-validation, process validation, equipment qualification in collaboration with relevant stakeholders
· Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Analytical development Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.
· Draft and review high-quality industry standard technical documents in appropriate format acceptable to FDA (Product development reports (PDR), protocols, reports, technical memorandums).
· Maintain effective and proactive communication and coordination of activities with multi-functional stakeholders.
· Accurately prepare and review R&D, exhibit batch and production work-orders (MMRs).
· Operational understanding of blenders, compression machines, encapsulation machines, dry/wet granulation machines and coating machines.
· Maintain proper documentation of product development process and results
· Provide support to production in process improvement and troubleshooting.
· Modify formulations and processes to enhance the functionality of existing products.
· Interaction with raw material manufacturers and other vendors as needed.
· Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
· Manage, coach, mentor and motivate junior scientists, operators and technicians for exceptional performance
· Other responsibilities as assigned by Senior Management
Education and Experience:
· 3-5 years of successful product development experience from within in ANDA Environment.
· MS degree in Pharmaceutical Sciences or related field is required
· Knowledge of CGMP’s, FDA, DEA, and OSHA regulations.
· Outstanding oral, written and computer skills are required
· Desire to work in a fast-paced manufacturing facility with unlimited career growth potential
Skills and Abilities:
· Excellent oral and written communications skills, working knowledge of MS Office
· Ability to prioritize and multitask
· Motivated, detailed, organized
· Knowledge of cGMP, computer software including word processing, Excel, and PowerPoint.
· Understands timelines and demonstrates a sense of urgency in work and in responding to customers and colleagues.
· Hours/Travel may be subject to change based on management/company discretion.
· While performing the duties of this job, the employee is regularly required to sit, stand or walk for long periods. The employee may lift and/or move up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
· For exempt employees, casual or incidental overtime worked is not compensable. When these extra efforts are either infrequent or of short duration, it is expected that exempt Employees will consider these extra hours per day, part of their professional employee/Company relationship and extend their efforts without additional compensation.
Personnel Protective Equipment or Attire Required for Position:
· As needed