Lead Analytical Chemist – API Development

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical benefits

401(k)

Job summary

Merck & Co. in Rahway, NJ, seeks a senior scientist to lead analytical efforts within the SAS-ACDS organization. The role focuses on analytical deliverables for API and drug substance manufacture in a fast-paced, multidisciplinary team.

Responsibilities include authoring procedures and reports, performing investigations, and contributing to regulatory submissions. Travel to represent the company may be required; strong ALCOA+ and communication skills are essential.

Qualifications

• Master of Science (MS) in Chemistry or related discipline with at least eight (8) years of relevant pharmaceutical development experience; PhD in Analytical Chemistry or related discipline with two or more (2+) years of experience.
• Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances.
• Strong verbal and written communication skills as well as flexibility to work in a dynamic environment (internal and external communications).
• Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• Ability to quickly adapt to changes and develop appropriate plans for managing risks.
• Advanced knowledge of ALCOA+ principles.
• Must be able to travel on our company's behalf.

Responsibilities

• Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity.
• Evaluate analytical methods associated with the critical quality attributes of cGMP materials.
• Responsible for technical training of staff, as needed, on analytical techniques and problem solving once established within our department.

Job description

Merck & Co. in Rahway, NJ, seeks a senior scientist to lead analytical efforts within the SAS-ACDS organization. The role focuses on analytical deliverables for API and drug substance manufacture in a fast-paced, multidisciplinary team.

Responsibilities include authoring procedures and reports, performing investigations, and contributing to regulatory submissions. Travel to represent the company may be required; strong ALCOA+ and communication skills are essential.