Job description
The Senior Formulation Scientist will work in a team environment and is responsible for helping to guide the Formulation Development group as well as lending support to the Operations group when conducting manufacturing operations. The fundamental duties include guiding the execution of projects, preparing or reviewing all related SOPs, maintaining cGMP operations, helping to manage staff, and providing technical support to Sales and Marketing.
Essential Duties and Responsibilities
- Develop formulations, primarily tablets and capsules, for clinical trials. Development efforts must balance speed and technical soundness.
- Lend support to manufacturing efforts carried out in Production operations.
- Function with reasonable independence and contribute significantly to the planning of research and development programs.
- Apply extensive knowledge to the development, planning and management of multiple research projects in Formulation Development.
- Correlate and interpret complex results and reach logical conclusions through the use of ingenuity and creativity in ideas. Recommend and initiate further projects/actions within existing programs. Contribute and implement new ideas/concepts and present in oral and written form, cogent research results to internal/external professionals. Provide advice, counsel and services used by others in taking action.
- Keep abreast of regulatory and related scientific enhancements, trends and advancements through independent reading and training.
- Ensure formulation development actions are in accordance with methods, protocols, SOPs and cGMP guidelines.
- Provide input to the development and implementation of installation, operation and performance qualifications on new and current manufacturing equipment in accordance with cGMPs.
- Design protocols necessary to complete projects. Also, provide advice and counsel to internal team and external professionals with projects.
- Prepare written reports for regulatory filings, publications, patent applications and the like in a timely and efficient manner.
- Advise management of significant observations, recommendations and conclusions pertaining to areas of responsibility and recommend potential actions to correct deviations from the norm or non-compliance.
- Review documentation such as laboratory notebooks, validation, analysis and regulatory reports, SOPs, methods and monographs.
- Provide technical support to Sales and Marketing to successfully establish Research Services as a new business.
- Attend trade shows as necessary in support of our sales effort.
- Interact professionally and effectively with business partners, assigned teams, management from different disciplines and all levels of company personnel.
- Develop systems that are cost effective and increase efficiency.
- Cooperate with other management personnel in formulating, establishing and implementing company policies, operating procedures and goals.
- Promote communication among the team by participating in meetings with pertinent updates and other developmental activities.
- Assess current model of business operations and develop appropriate new models as needed by monitoring and reviewing current manufacturing equipment and techniques.
- Ensure that new inventions and experimental evidence are properly documented as evidence of invention and reduction to practice.
- Adhere to set safety standards.
- Participate as a team member, support the company mission and vision and contribute to the pursuit of the company's goals.
- Achieve expected performance measures.
- Other duties as assigned.
Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.
Job Type: Full-time
Pay: $110,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person
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