Bio/Sterile Drug Product Process Expert

Real Staffing; Boston (MA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Real Staffing is seeking a Bio/Sterile Drug Product Process Expert to oversee sterile manufacturing at CMOs, ensuring compliant processes and timely investigations. This 12-month contract role emphasizes technical leadership, cross-functional collaboration, and regulatory readiness.

The ideal candidate has a strong background in sterile formulations, aseptic fill/finish, and GMP/GxP with experience in regulatory filings and continuous improvement initiatives in a global environment.

Qualifications

• BS or MS in a relevant technical field with experience in sterile drug product formulation and process development.
• GxP and multinational regulatory guidelines knowledge is required.
• Experience with regulatory submissions and external CMOs is preferred.

Responsibilities

• Provide day-to-day technical oversight of activities at external CMO partners.
• Drive investigations, changes and continuous improvements in line with team goals.
• Collaborate with Quality, Operations, Supply Chain and Manufacturing.
• Review manufacturing processes and CPV for commercial products.
• Participate in Joint Technical Team coordination with CMOs and SMEs.
• Perform risk assessments and contribute to regulatory filings.

Skills

Sterile formulation

Aseptic fill/finish

GxP knowledge

Regulatory submissions

Process risk assessment

Regulatory inspections

Statistical analysis (Minitab/JMP)

Cross-functional collaboration

Problem-solving tools

Education

BS in Pharmaceutical Sciences or Chemical Engineering

Tools

Minitab

JMP

Job description

Job Title: Bio/Sterile Drug Product Process Expert (12- Month Contract + Benefits)

Location: Boston, MA (Hybrid) | Remote Considered

About the Opportunity

Our client is seeking a Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external Contract Manufacturing Organizations (CMOs). This individual will serve as a subject matter expert supporting commercial sterile products, driving technical investigations, process improvements, regulatory activities, and cross-functional collaboration across Quality, Operations, Supply Chain, and Manufacturing.

Primary Responsibilities

• Day-to-day technical oversight of activities at external CMO partners
  • Provide technical oversight at Drug Product CMOs within the External Manufacturing organization framework
  • Proactively drive technical deviation investigations, change implementations and continuous improvements in alignment with technical team and Virtual Plant Team goals
  • Collaborate efficiently with Quality, Operations, Supply Chain and extended teams
  • Maintain and review Drug Product manufacturing process monitoring for commercial products as part of robust Continuous Process Verification
• Cross-functional team participation
  • Actively participate in Virtual Plant Team led by Operations
  • Serve as the primary point of contact (with SME oversight) for Joint Technical Team responsible for coordinating with CMO point of contact to drive agenda, moderate meetings and review minutes
• Subject Matter Expertise (SME)
  • Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practices
• Familiarize with and author/review CMC related sections for regulatory filings
• Other duties as required by management

Education and Required Skills

• Minimum B.S. degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with a minimum of 6 years relevant experience or a M.S. degree in Pharmaceutical Sciences or Chemical Engineering with a minimum of 5 years of relevant experience in sterile drug product formulation and process development and manufacturing including experience with regulatory submissions
• In-depth knowledge of sterile drug product formulation concepts/techniques and aseptic fill/finish processes as well as relevant GxPs and multinational regulatory guidelines
• In-depth knowledge of container closure components as well as single-use components and technologies typically used in aseptic processing
• Experience in a variety of problem-solving tools (e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.)
• Strong analytical skills, attention to detail, and ability to plan, organize, and manage multiple projects simultaneously
• Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams that require collaboration, influencing and negotiation skills, and analytical judgement
• Working knowledge in microbiology and extractables/leachables techniques and regulations
• Experience with basic statistical methodologies and software (e.g., Minitab, JMP or equivalent)
• Experience in collaborating with Contract Development / Manufacturing Organizations and external partners
• Excellent written and oral communication and presentation skills

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.