About the Position:
Ascendia Pharma is looking for formulation associate scientist, scientist for its Pharmaceutical R&D. This position will conduct activities related to formulation development under research and development settings. The successful candidate will be actively involved in developing formulation and manufacturing process and transferring these methods and processes to drug product manufacturers. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role with the expectation that this scientist will interact with all disciplines of drug development, including discovery, pre-clinical, clinical, pre-formulation, analytical R&D, and regulatory. A thorough understanding of pharmaceutical development process from discovery to commercialization is highly desirable.
Principal Responsibilities:
Design formulations and process for complex and challenging compounds.
Actively involved in project management and product development strategies. Handle all technical, legal, and regulatory aspects of development projects.
Participate in discovery and clinical development project team to inform and update the team on the status of all active projects
Write and review CMC reports and documentation for regulatory filings.
Keep current with regulatory guidelines, technical innovations, and new developments within pharmaceutical industry.
Qualifications
The position requires a B.S or M.S. degree in Pharmaceutics, Chemistry, Physical Pharmacy, Chemical Engineering, or Pharmaceutical sciences with relevant pharmaceutical industry experience.
Industrial experience in oral, parenteral, or others dosage form development, process optimization and scale-up
Experience in Innovative approaches to solving formulations challenges and formulation technologies to improve solubility and bioavailability of poorly water-soluble drug is preferred.
In-depth understanding of preformulation, formulation, biopharmaceutics principles required to get a drug from discovery through clinical development is desirable.
Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents. Proficient in using computer to write and review technical reports and scientific judgment in data evaluation.
Excellent communication skills, problem solving, critical thinking, and organization skills. Ability to work in a fast-paced organization with diverse project teams and personnel.
Knowledge in pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.
EEO/AA M/F/V/D
Please visit our website at www.ascendiapharma.com for more information.
Job Type: Full-time, Contract, Temporary
Job Types: Temporary, Internship, Contract, Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Supplemental pay types:
Education:
Experience:
- pharmaceutical: 1 year (Preferred)
Work Location: In person