Formulation Scientist/Senior Scientist Job Summary * Under general direction, manages, plans, and ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Quick apply
Formulation Scientist/Senior Scientist Job Summary * Under general direction, manages, plans, and ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Description Formulation Scientist/Senior Scientist Job Summary * Under general direction, manages ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Description Formulation Scientist/Senior Scientist Job Summary * Under general direction, manages ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Job Type Full-time Description Formulation Scientist/Senior Scientist Job Summary * Under general ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Job Type Full-time Description Formulation Scientist/Senior Scientist Job Summary * Under general ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...
Formulation Development Cmc information
What are the key skills and qualifications needed to thrive as a Formulation Development CMC specialist, and why are they important?
To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.
What are some typical challenges faced by professionals in Formulation Development CMC, and how are they addressed?
Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.
What is Formulation Development CMC?
Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.
What is the difference between Formulation Development Cmc vs Formulation Scientist?
| Aspect | Formulation Development Cmc | Formulation Scientist |
|---|---|---|
| Credentials | Bachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certifications | Bachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields |
| Work Environment | Pharmaceutical or biotech R&D labs, manufacturing settings | Research labs, development facilities, pharmaceutical companies |
| Industry Usage | Regulatory submissions, product development, manufacturing support | Formulation research, experimental design, product optimization |
Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.
What are popular job titles related to Formulation Development Cmc jobs in Virginia? For Formulation Development Cmc jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Formulation Development Cmc jobs in Virginia look for? The top searched job categories for Formulation Development Cmc jobs in Virginia are:
- Work From Home Formulation Scientist Pharmaceutical
- Telecommute Director Formulation Development
- Associate Process Development Scientist
- International Development Studies
- Phd Pharmacology Salary
- Director Assay Development
- Dietary Supplement Formulation Scientist
- Full Time Downstream Process Development Scientist
- Associate Purification Scientist
- Global Therapeutics
What cities in Virginia are hiring for Formulation Development Cmc jobs? Cities in Virginia with the most Formulation Development Cmc job openings:
Full-time
Posted 16 days ago
Job description
Description:
Formulation Scientist/Senior Scientist
Job Summary
- Under general direction, manages, plans, and executes projects for product development.
- Under limited direction and supervision, carries out design and development of solid oral dosage forms using quality by design (QbD concept) through ANDA filing and/or product launch.
- Under limited direction and supervision, carries out design and development of complex oral dosage forms using QbD concepts through ANDA filing and/or product launch.
- Develops and executes formulation strategies related to product development (i.e., project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions
- Coordinates studies with other technical groups (i.e., Analytical Sciences, Biopharmaceutics, Legal, Regulatory & Tech Services).
- Maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of oral controlled release drug products.
- Participates as a project leader, manager and/or ad hoc member in Product Development efforts, and identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.
Principal Accountabilities
JOB DUTIES & RESPONSIBILITIES
- Developing pharmaceutical products, leading to successful ANDA filings and approval in a timely manner.
- Managing and scheduling multiple projects, setting objectives, prioritizing activities to meet the milestones in a fast-paced environment.
- Designing, formulation and process development for various drug from project initiation to commercialization by following appropriate GMP regulations and safety requirements.
- Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs in collaboration with the R&D technician.
- Design and conduct pre-formulation and formulation studies, process development and optimization of prescription dosage form designs and ANDA oral Dosage forms using DOE
- Perform Literature search and Evaluate patents to develop non-infringing strategies
- Preparation of product manufacturing, batch records and protocols for different product development stages, including from R&D prototype formulations to process validations following SOPs and procedures, ensuring the detailed record and data keeping.
- Utilize formulation techniques, processing equipment and unit operations including Wurster Coating, Tablet Coating, Compression, Blending, Encapsulation, HPLC, Spectrophotometry, Dissolution, Viscometer to develop Bio-Equivalent products
- Review Analytical Data, draft SOP’s, Process Evaluation protocols, IQ, OQ, PQ protocols and GMP Manufacturing Batch records, Packaging Batch Records.
- Characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs.
- Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
- Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory requirement, and FDA onsite inspections.
- Comprehensive knowledge of IVIVC, QbD and Design of Experiments (DOE).
- Ensuring all regulatory documents in compliance with SOPs, FDA Regulations, and cGMP policy where applicable.
- Knowledge of manufacturing regulatory programs and objectives (cGMP, CFR 210 and 211).
- Maintaining compliance with GMP, SOPs and DEA regulations.
- Coordinate with Regulatory Affairs, Operations, QC/QA and Supply Departments to ensure that projects are planned and executed in a timely manner.
Management Responsibility
The Senior Scientist leads the assigned projects and guides the operation of the product development ranging from selection of staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, hours of operation, scheduling of staff, and utilization management.
Reports to
Sr. Vice President, R&D
Requirements:Minimum Requirements
Knowledge & Skills Good communication skills, critical thinking, flexibility, time management, self-motivation.
Minimum Experience & Education
- Ph.D. in pharmaceutical sciences with minimum of 2 years' experience OR;
- Masters in pharmaceutical sciences with minimum of 5 year' experience in generic product development, with emphasis in solid/liquid orals or an equivalent combination of education and experience.
Disclaimer:The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.