Essential Duties and Responsibilities:

The individual will be a member of the Product Development team and will support the development and testing of drug products under the guidance of senior staff. He or She will be responsible for the close and effective coordination and tracking of formulation activities under tight program timelines with cross-functional accountability and interdependence. The ideal candidate will leverage existing experience to manage formulation activities for many active projects from early to late stage of drug product development.

•Develop and scale up formulations and manufacturing processes for complex dosage forms with minimal guidance, including pre-formulation, formulation, and process development

•Familiar or capable of independent operation of commonly used equipment in formulation development lab

•To write up and review protocol, batch records and product development report with high quality

•Be able to show flexibility and ability to work on ad-hoc assignment

Qualifications:

•MS with 0-3 years of experience or PhD with 0-1 years of experience in pharmaceutical industry or otherdirectly related science discipline, preferably be trained in formulation/dose development & process development of pharmaceutical drug products

•Strong scientific background and working knowledge of conducting pharmaceutical pre-formulation, formulation, and process development studies of various complex dosage forms

•Experience in manufacturing process unit operations, scale-up, technology transfer, and in-process control testing.

•Familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines and experience in FDAANDA regulatory submission.

•Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.

•Be able to work in a team-oriented manner to accomplish performance objectives.

•Be accountable and demonstrate good working ethics, integrity, ownership, and leadership.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Education:

• Master's (Preferred)

Work Location: In person