Manufacturing Specialist II – 2nd Shift

Initial Therapeutics, Inc.; Petersburg (VA); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Manufacturing Specialist II to support the startup of their facility. This role is crucial for ensuring the smooth operation of daily manufacturing processes and the timely production of pharmaceuticals. You will collaborate with various teams, provide training, and manage manufacturing documentation while maintaining high-quality standards. The ideal candidate will have extensive experience in a cGMP environment, demonstrating strong communication and problem-solving skills. If you thrive in a fast-paced setting and are passionate about quality in production, this is the opportunity for you.

Qualifications

• 6+ years in a cGMP production environment or 8+ years with a High School diploma.
• Strong communication and collaboration skills required.

Responsibilities

• Support daily manufacturing operations and timely production of pharmaceuticals.
• Collaborate with cross-functional teams to meet production needs.

Skills

cGMP production experience

Attention to detail

Communication skills

Collaboration skills

Basic math skills

Education

Associate degree

High School diploma

Tools

Microsoft Office suite

ERP systems

Job description

Position Summary

We are looking for a Manufacturing Specialist II – 2^nd shift who will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the nested line and the timely production of pharmaceuticals.

Duties & Responsibilities

• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.
• Support onboarding and provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
• Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
• Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.
• Lead efficient GMP document and record reviews to minimize routing time.
• Provide technical expertise and support regulatory inspections as an SME for the area.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.
• Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration.
• Develop and track KPI metrics to identify opportunities, failure points, and trending models.
• Flex schedule to work outside routine 2nd shift hours at times to accommodate activities as needed.

Required Qualifications

• Associate degree with 6+ years demonstrated ability in a cGMP production environment. High School degree with 8+ years of experience of cGMP production experience may be considered.
• Experience with sterile fill finish manufacturing.
• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Proficiency in Microsoft Office suite. Strong communication and collaboration skills, with a commitment to meeting high-quality standards.
• Must be able to complete eye exam and have the visual ability to detect defects.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Basic math skills to perform required calculations (multiplication/division),
• Good deviation and investigation writing skills.
• Ability to work autonomously and within established guidelines, procedures, and practices.

Preferred Qualifications

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Equipment qualification experience.
• Experience in using ERP systems.