Chemist (Manufacturing Associate)

Responsibilities

• Research, develop and execute all activities relating to the manufacturing/packing of various pharmaceutical dosage forms by performing scientific analysis/lab testing/validations etc. while working under the supervision of Sr. Manufacturing Scientist/Manager.
• Follow guidance to review and perform execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of production equipment to meet validation and regulatory requirements. Will perform installation and operation qualifications for all injectable equipment.
• Conduct qualification and performance verification of dry powder injectable facilities and equipment as instructed.
• Assist Sr. Scientists/Manufacturing Manager to plan and execute batch dispensing and manufacturing activities. Will compile scientific/technical documentation involved in execution of commercial & validation batches & draft documents for regulatory aduits, ANDA submissions to US FDA and cGMP documentation with reference to manufacturing department.
• Follow established guidelines/plans to ensure effective implementation of quality management system (QMS) as per CGMP and regulatory requirements at all levels of manufacturing by collecting/researching/analyzing scientific data/reports, recording scientific evidence/results from development/manufacturing activities etc.
• Draft manufacturing department SOPs for manager’s review and approval.

Qualifications

• Hands-on experience in sterile manufacturing support, validation activities, and cross-functional collaboration within a regulated pharmaceutical environment.

Skills

• Strong scientific background in chemistry and related fields.
• Experience with sterile manufacturing processes and cGMP regulations.
• Excellent organizational and problem-solving skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Benefits

• Flexible schedule
• Competitive compensation package
• Professional development opportunities
• Health insurance benefits
• Employee discounts

Pay

• $60,000 - $70,000 annually

Schedule

• Full-time