Senior Scientist, CMC Analytical Development

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Full Time Exton, PA, US

9 days ago Requisition

Sr. Scientist – CMC Analytical Services

Title :
Sr. Scientist

Location: Exton, PA

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Job Description :

• Provide analytical support for developing and manufacturing active pharmaceutical ingredients (API).
• Conduct analytical method development and validation for drug substance and drug product.
• Draft and review analytical methods and method validation/verification/transfer protocols and reports.
• Draft and review other technical study protocols and reports.
• Perform identification of unknown impurities in drug substances and drug products.
• Coordinate with team members to execute studies and lead studies when required.
• Communicate and work closely with team leader to complete projects in a timely manner.
• Evaluate and resolve technical and instrumental issues.
• Comply with internal standard operating procedures, all relevant cGxP regulatory requirements.

Qualifications:

• Ph.D. degree in synthetic organic chemistry or related fields.
• M.S. degree in organic chemistry or related fields with minimum three years of industrial experience.
• Experience in HPLC and LC/MS instruments is desirable.
• Good verbal and written communication skills.
• Good analytical, logical thinking and problem-solving skills, and the ability to adapt to changing priorities and deadlines.
• Strong planning and organization abilities.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.