What are the responsibilities and job description for the Formulation Scientist position at Havix Group LLC?
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider. Aavis Pharmaceuticals. We currently have an exciting opportunity available for a Formulation Scientist.
The Formulation Scientist is responsible for the development of the formulation for various pharmaceutical products. The Formulation Scientist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.
Key Responsibilities include but are not limited to:
- Responsible for developing various pharmaceutical products leading to successful NDA/ANDA filings and approval in a timely manner through internal or external sources.
- Responsible for handling multiple projects, prioritizing activities to meet the milestones in a fast pace environment.
- Responsible for reviewing literature and patents and work on the technical approaches for pharmaceutical/ ANDA product development.
- Designing and conducting experiments for pre-formulation, formulation/process development, scale-up for various drug dosage forms by following appropriate GMP regulations and safety requirements.
- Responsible for execution of Registration batches and technology-transfer/ process development batches.
- Responsible for preparation / review of product batch records and protocols for different product development stages, including from R&D prototype formulation, scale-up to process validation by following related SOPs and procedures, ensuring the detailed record and data keeping.
- Responsible for characterization of API, excipients, compatibility studies, conduct formulation trials, compile & review data to support successful development.
- Supporting R&D function, select proper equipment for various dosage form product development; developing SOPs and technical documents to support IQ/OQ/PQ processes of equipment.
- Ensure all equipment is in a good condition to safely and effectively conduct product development experiments in a timely manner; maintaining formulation Lab in a clean and safe working environment.
- Write / record development work and draft technical reports to support product development, specifications, and stability in NDAs/ANDA and other regulatory submissions.
- Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
- Maintaining compliance with GMP, SOPs and DEA regulations.
- Other duties as assigned.
Qualifications and Requirement:
- Master’s degree in Pharmaceutical Sciences or related discipline.
- At least 2 years relevant work experience in Generic/ ANDA pharmaceutical product development.
- In-depth theoretical and hands on experience in pharmaceutical technologies and equipment for various dosage forms (mainly oral solids like tablets, capsules etc.), including sustained release (MR/DR) formulations.
- May handle hazardous materials and may require wearing personal protective equipment as needed
- Must be able to move about the laboratory and the facility
- Must be able to remain in an upright position for periods of time.
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more...