Parenteral Operations Scientist
1 day ago
A contract development and manufacturing organization (CDMO) focused on getting products to patients faster by being agile, accountable, and transparent. Our team of experts believe in collaboration and customizing our services to assist our clients through the drug development process.
Parenteral Product Development and Manufacturing Science is core to our competency and vision in service of clients advancing new therapeutic agents through the product life cycle.
The Manager, Parenteral Operations MST serves as a leader and technical expert responsible for transfer activities leading to a robust and reliable manufacturing of selected parenteral product presentations using our manufacturing technology platform. Together with his/her team, will advance and deploy manufacturing sciences expertise for end-to-end parenteral operations for formulation, filling, and inspection lines. Serves as technical parenteral operations resource for internal parties. This role’s objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. This role is expected to interface regularly with the manufacturing operations and engineering teams in support of day-to-day operations.
The following key functions will be carried out in accordance with the company’s vision, mission, standards, goals, objectives, and strategic direction.
- Ensure phase appropriate transfer and scale up/scale down for clinical material from our clients to internal manufacturing platforms
- Lead and ensures the success of new process and product presentations into manufacturing.
- Ensures that technology transfer documentation is completed timely and enables flawless execution.
- Drives the implementation of continual improvements documents associated with process transfer to manufacturing.
- Coordinates timely “Lessons Learned” reflecting and leveraging acquired outcomes to future activities
- Prepare and Review, as required, relevant technical documents, such as: Batch Records, Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFMEAs, etc.
- Performs assessments of incoming product and process knowledge available in scope of new technology transfers
- Provide input and requirements to drug product development in relation to materials in direct product contact (i.e single use materials, primary container closure systems)
- Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key document.
- Assess new technologies/applications: feasibility, business case, conceptual design, installation and implementation.
- Evaluates the required resources and timing necessary to execute clients’ studies.
- Designs process characterization studies and leads the team to complete execution of agreed upon work and milestones.
- Participates to knowledge generation and integration across R&D and Ops activities.
- Shares acquired knowledge internally and during client meetings ? Establish metrics on tasks, performance, and status of deliverables for Technical Operations activities.
- Performs data analytics to convert results into knowledge, provide useful and easy to use structured information than transferred into clients reports.
- Functions as department’s Parenteral Manufacturing Science subject matter expert.
- Leads and grows a team focused on support to manufacturing and prepares instructions and documents required for product manufacturing.
- Mentor scientists, MS&T and process engineers
- Manages the MST department and performs standard supervisory duties assigned by Human Resources, including by not limited to mentoring employees.
- Actively participates on the Leadership Team
- Manage the department’s budget. ? Provides ongoing support for building executable protocols, documenting with accuracy, execution and summarizing study outcomes. Shares results and outcomes internally and to clients.
- Supports Business Development and Client Services on new and repeated business.
- Participates in Client and Regulatory Audits and Inspections.
- Supports Business Development by attending trade shows and conferences.
Characteristics Required Include:
- Demonstrated proficiency and experience with pharmaceutical sterile process development and fill/finish operations, in particular isolators and robotic filling technologies
- Experience with clinical development and manufacturing
- Motivated with the ability to work independently and manage direct reports with demonstrated problem-solving skills is required.
- Strong experimental and technical writing and documentation skills, experiments in pharmaceutical regulated environment following (i.e 21CFR 211 )
- Strong interest and commitment to exceptional customer service and teamwork.
- Excellent time management, organization skills, and ability to manage multiple priorities
- Excellent communication and presentation skills – ability to communicate effectively across various audiences
Work Experience & Educational Requirements:
- PhD in Pharmaceutical, Biochemical, Chemical, Life Sciences, Engineering or a related field with 7+ years of experience. OR
- Master's degree with 10+ years of experience OR
- Bachelor's degree with 12+ years of experience is required.
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