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Director Drug Product Formulation Development Jobs in Virginia

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Director Drug Product Formulation Development information

What does a director drug product formulation development do?

A Director of Drug Product Formulation Development leads teams responsible for designing and optimizing pharmaceutical formulations, ensuring that drugs are safe, effective, and manufacturable at scale. This role involves overseeing the development of drug products from early-stage research through to clinical trials and commercial manufacturing. The director collaborates with cross-functional teams, manages regulatory compliance, and ensures that product development aligns with company goals and industry standards.

What are the key skills and qualifications needed to thrive as a director drug product formulation development, and why are they important?

To thrive as a Director of Drug Product Formulation Development, you need an advanced degree in pharmaceutical sciences or a related field, extensive experience in formulation development, and a deep understanding of regulatory requirements. Familiarity with analytical instrumentation, formulation software, and quality management systems, as well as certifications like PMP or Six Sigma, are highly beneficial. Strong leadership, strategic thinking, and cross-functional communication skills set outstanding candidates apart. These competencies ensure the successful development, optimization, and regulatory approval of drug products in a highly competitive and regulated environment.

What are some typical challenges faced by a director drug product formulation development, and how are they addressed within the team?

A Director of Drug Product Formulation Development often encounters challenges such as balancing innovative formulation approaches with regulatory compliance, managing cross-functional timelines, and ensuring scalability from laboratory to commercial manufacturing. Addressing these challenges typically involves close collaboration with analytical, regulatory, and manufacturing teams to align goals and troubleshoot issues early. Open communication, regular project reviews, and fostering a culture of continuous learning help the team adapt quickly to evolving project requirements and industry standards.

What are popular job titles related to Director Drug Product Formulation Development jobs in Virginia?

For Director Drug Product Formulation Development jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Director Drug Product Formulation Development jobs in Virginia look for?

The top searched job categories for Director Drug Product Formulation Development jobs in Virginia are:

What cities in Virginia are hiring for Director Drug Product Formulation Development jobs?

Cities in Virginia with the most Director Drug Product Formulation Development job openings:

Equipment Technician - Sterile Drug Manufacturing, VA

Global Recruiters Network

Wakefield, VA

Other

Re-posted 16 days ago


Job description

Process and Equipment Maintenance Tech

1st and 2nd shift (2nd shift 10% shift diff)

Position Summary

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment operates in a highly technical environment requiring experience related specifically to maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment applies critical thinking and considers all business impact aspects before taking job-related actions that could cause unwanted consequences such as unsafe events, equipment failure and other risks. The Maintenance Technician, Process Equipment is able to apply independent judgment and perform in a small company environment, where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset and driving a positive team culture.

Essential Duties and Responsibilities

· Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.

· Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.

· Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.

· Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.

· Support the coordination and execution of calibrations and preventative maintenance activities.

· Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.

· Proactively work with supports teams Ein developing solutions for equipment issues.

· Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.

· Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).

· Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.

· Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.

· Assist R&D and MSAT on new product introduction and technology transfer activities.

· Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.

· Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.

· Is on call periodically to monitor and respond to manufacturing equipment repairs and issues.

· Other duties as assigned.

Basic Qualifications (Knowledge, skills, and abilities)

· High school diploma with 4 years of experience as executing maintenance to manufacturing equipment or an associate's degree or higher in Pharmaceutical Sciences, Engineering or a related field is preferred.

· Experience with sterile fill-finish manufacturing.

· Knowledge of GMP, regulatory requirements, and industry best practices.

· Ability to work autonomously and within established guidelines, procedures, and practices.

· Experience in a continuous process improvement environment, including change management.

· Experience in using Computerized Maintenance Management Systems.

· Strong communication and collaboration skills, committed to meeting high-quality standards.

Preferred Qualifications

· Knowledge of high-speed aseptic filling and isolator barrier system technology.

· Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.

· Proficiency in Microsoft Office Suite.

Physical Demands and Work Environment

The physical demands described here represent those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation

may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.