Senior Associate, Manufacturing

Job Description

This position will be responsible for managing manufacturing and development activities for pharmaceutical drug products. When required, this position will act as the Person-in-Plant during production runs. This role will also be responsible for working with internal supply chain, analytical development, quality assurance, and regulatory affairs for the oversight and coordination of activities related to scheduling, manufacturing, quality, supply chain, and regulatory.

Responsibilities

• Support management of drug product manufacturing at Contract Manufacturing Organizations (CMOs).
• Ensure that manufacturing activities comply with current Good Manufacturing Practice (cGMP) regulations and regulatory filings.
• Review and approve change controls, manufacturing batch records, protocols, and reports, and organize and archive documents in Veeva Quality Docs System.
• Collaborate with CMOs to troubleshoot, investigate, and resolve manufacturing issues and deviations. Ensure timely closure of deviations, investigations, corrective and preventative actions, effectiveness checks, and implementations at CMOs.
• Assist with drug product manufacturing and process development/optimization projects, and review/author protocols, reports, and regulatory submissions.
• Collate manufacturing data to develop metrics, control charts, and reports to improve manufacturing processes.
• Assist in drafting, formatting, and routing of manufacturing-related SOPs.
• Collaborate cross-functionally with the internal team and corresponding functional groups at the CMOs per the following:
  • Supply Chain: Ensure product shipments adhere to manufacturing schedules and forecasts
  • Quality Assurance: Ensure manufacturing activities adhere to cGMP standards
  • Regulatory Affairs: Assist in drafting/reviewing regulatory submissions and agency communications
• Act as a company liaison and Person-in-Plant for critical manufacturing runs. Position requires 10-20% travel.

Preferred Education and Experience

• BA/BS degree in relevant scientific/technical/engineering field.
• 3-5 years’ experience in pharmaceutical development and/or manufacturing, in an outsourced manufacturing environment.
• Must have basic knowledge of cGMP regulations and quality management systems.

Preferred Skills, Qualifications, or Technical Proficiencies

• Working knowledge of documents related to GMP and development regarding manufacturing, analytical development, and supply chain.
• Must have high proficiency in use of MS Office applications (Word, Excel, PowerPoint, Project) and have good working knowledge of basic statistics.
• Detail-oriented, highly organized, with good initiative and a customer-service attitude. Enjoy working independently.
• Interested in learning about technical aspects of CMC activities.