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Small Molecule Drug Development Jobs in Virginia

Merck

Quality Drug Substance Design Lead

Elkton, VA

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Join a purpose-built, agile small molecule manufacturing site where your work will help bring ... Support inspection readiness and the development of complete, accurate, and traceable documentation.

Merck & Co.

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Join a purpose-built, agile small molecule manufacturing site where your work will help bring ... D and receiving sites to ensure effective process knowledge transferContribute to process fit ...

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Small Molecule Drug Development information

What is small molecule drug development?

Small molecule drug development is the process of discovering, designing, and bringing to market pharmaceutical compounds that have low molecular weight and can easily enter cells to affect biological processes. These drugs are typically administered orally and are used to treat a wide range of diseases. The development process involves several stages, including target identification, compound screening, preclinical testing, and clinical trials before regulatory approval. Small molecule drugs are distinct from biologics, which are larger and more complex molecules like proteins or antibodies.

What are some common challenges faced by professionals in small molecule drug development, and how can they be addressed?

Professionals in small molecule drug development often face challenges such as balancing tight project timelines with rigorous regulatory requirements and managing cross-disciplinary collaboration between chemistry, biology, and clinical teams. Navigating unexpected results in preclinical or clinical studies can also require rapid problem-solving and adaptation. Building strong communication skills and staying updated on the latest regulatory guidelines and scientific advances can help address these challenges. Working closely with team members from diverse backgrounds fosters innovative solutions and keeps projects on track.

What are the key skills and qualifications needed to thrive in small molecule drug development, and why are they important?

To thrive in Small Molecule Drug Development, you need a strong background in chemistry, pharmacology, and molecular biology, typically supported by an advanced degree such as a Ph.D. or M.S. in a related field. Proficiency with laboratory techniques, analytical instrumentation (like HPLC and mass spectrometry), and drug discovery software is essential. Strong problem-solving skills, collaboration, and project management abilities help professionals excel in multidisciplinary teams. These skills and qualities are critical for efficiently advancing compounds through the drug discovery pipeline and ensuring compliance with regulatory standards.

What are popular job titles related to Small Molecule Drug Development jobs in Virginia?

For Small Molecule Drug Development jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Small Molecule Drug Development jobs in Virginia look for?

The top searched job categories for Small Molecule Drug Development jobs in Virginia are:

What cities in Virginia are hiring for Small Molecule Drug Development jobs?

Cities in Virginia with the most Small Molecule Drug Development job openings:

Small Molecule Drug Development jobs near you

Senior Director, Small Molecule Drug Product Manufacturing

PVH (Tommy Hilfiger/Calvin Klein)

Hopewell, VA • On-site

$180 - $280/hr

Other

Posted 14 days ago

PVH Corp. rating

6.3

Company rating: 6.3 out of 10

Based on 7 frontline employees who took The Breakroom Quiz

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Senior Director is responsible for the overall leadership, performance, and regulatory compliance of the Small Molecule Drug Product Manufacturing facility. This role has full accountability for Safety, Quality, Delivery, Cost, and People across all manufacturing operations including dispensing, granulation, blending, compression, coating, encapsulation, packaging, warehousing, and associated support functions. As a key member of the Site Leadership Team, the Senior Director develops and executes operational strategies to ensure reliable supply of commercial products while driving operational excellence, continuous improvement, and organizational capability growth. The position is accountable for maintaining a state of inspection readiness and ensuring compliance with all FDA, EMA, and global regulatory expectations.

Essential Functions of the Job
  • Influence manufacturing strategy and network planning.
  • Partner with cross functions to support product launches and long-term capacity needs.
  • Represent manufacturing in executive governance meetings.
Manufacturing Leadership
  • Provide strategic and operational leadership for all small molecule drug product manufacturing activities.
  • Ensure delivery of production schedules while maintaining safety, quality, and compliance standards.
  • Lead facility startup, expansion, technology transfer, validation, and commercialization initiatives.
  • Develop and execute long-range manufacturing capacity and resource plans.
  • Drive manufacturing performance through KPI management and operational reviews.
Quality & Compliance
  • Ensure strict adherence to cGMP, FDA, EMA, ICH, and corporate quality standards.
  • Maintain continuous inspection readiness across all manufacturing areas.
  • Partner with Quality to oversee deviations, investigations, CAPAs, change controls, and risk assessments.
  • Serve as primary manufacturing representative during regulatory inspections and customer audits.
  • Foster a culture of quality ownership and data integrity throughout the organization.
Operational Excellence
  • Implement Lean Manufacturing, Six Sigma, and continuous improvement programs.
  • Improve OEE, productivity, batch cycle times, right-first-time performance, and manufacturing throughput.
  • Lead root cause investigations and implementation of sustainable corrective actions.
  • Establish benchmarking and performance metrics to drive operational excellence.
Financial Management
  • Own manufacturing operating budget and financial performance.
  • Manage labor, maintenance, materials, and operational expenditures.
  • Identify and deliver cost savings initiatives while maintaining compliance and product quality.
  • Support capital planning and execution for facility and equipment investments./
Technical Operations
  • Provide strategic oversight of:
  • Oral solid dosage manufacturing
  • Tablet compression
  • Encapsulation
  • Film coating
  • Granulation and blending
  • Dispensing operations
  • Packaging and serialization
  • Warehouse and material handling operations
  • Support implementation of new technologies and manufacturing platforms.
  • Ensure facilities and equipment remain qualified and operating within validated state.
EHS Leadership
  • Promote a strong safety culture based on proactive identification and mitigation of risk.
  • Ensure compliance with all safety, environmental, and occupational health requirements.
  • Lead site EHS performance reviews and corrective action programs.
People Leadership
  • Build, develop, and retain a high-performing manufacturing organization.
  • Lead through coaching, succession planning, and talent development.
  • Establish clear goals, accountability, and performance expectations.
  • Foster collaboration across Manufacturing, Quality, Supply Chain, Engineering, Validation, Technical Services, and EHS.
Supervisory Responsibilities
  • 10+ years of managerial experience directly managing people
  • Direct leadership of Manufacturing Managers, Production Supervisors, and Operations Leaders.
  • Indirect leadership of production technicians, operators, warehouse personnel, and support functions.
  • Member of Site Leadership Team.
Computer Skills

Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Other Qualifications

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline and 12+ years of pharmaceutical manufacturing experience required. (Master's degree and 8+ years of experience preferred; MBA desirable).

10+ years of progressive leadership experience in GMP pharmaceutical operations.

Demonstrated success managing commercial small molecule drug product manufacturing facilities.

Experience supporting FDA, EMA, M

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