MS&T Associate (Drug Product - Virtual Operations)

Job Title: MS&T Associate (Drug Product - Virtual Operations)

Department:
Manufacturing Science & Technology (MS&T)

Reports To:
MS&T Manager

Location:
Dublin Office (Greater Dublin Based Graduate - preferrable)

Position
Summary

The
MS&T Associate supports the technical oversight and lifecycle management of
outsourced drug product manufacturing processes. Operating within a virtual
pharmaceutical model, this role collaborates closely with Contract Development
and Manufacturing Organizations (CDMOs) to ensure robust process performance,
regulatory compliance, and reliable product supply.

The
position focuses on technology transfer, process validation, deviation oversight,
and continuous improvement across external manufacturing partners.

Key Responsibilities

External Manufacturing Oversight

• Provide technical coordination between
  the company and CDMOs for drug product manufacturing activities.
• Monitor manufacturing performance through
  batch data review, trend analysis, and KPI tracking.
• Provide technical input and oversight
  during manufacturing campaigns.

• Technology Transfer

• Support transfer of drug product
  processes to CDMOs, including:
• • Process knowledge transfer
  • Collation of Technology Transfer
    documentation
  • Participation in Request
    For Quotation (RFQ) and contract reviews
• Assist in planning and execution of
  engineering runs and PPQ batches at external sites.

Process Validation & Lifecycle Management

• Support process validation activities,
  including protocol and report review (PPQ, cleaning validation, hold time
  studies).
• Ensure continued process verification
  (CPV) programs are maintained at CDMOs.
• Contribute to lifecycle management
  strategies, including post-approval changes.

Change Control Support

• Evaluate proposed changes from CDMOs
  (e.g., process, equipment, raw materials).
• Support internal change control processes
  and regulatory impact assessments.
• Provide technical justification for
  changes in submissions and filings.

Documentation & Regulatory Support

• Author, review, and approve technical
  documents including:
• • Process descriptions and
    control strategies
  • Comparability assessments
  • Sections of regulatory
    filings (e.g., Module 3 CMC)
• Support responses to health authority
  queries related to drug product manufacturing.

Cross-Functional Collaboration

• Work closely with Quality, Regulatory
  Affairs, Supply Chain, and CMC teams.
• Participate in governance meetings with
  CDMOs (e.g., technical review boards, business reviews).
• Support audits and inspections by
  providing technical expertise.

Qualifications

Education

• Bachelor’s degree in Chemical
  Engineering, Pharmaceutical Sciences, Biotechnology, or a related
  discipline.

Experience

• 1-3 years of experience in
  pharmaceutical/biopharmaceutical industry.
• Experience with drug product
  manufacturing or MS&T, in a CDMO or virtual company environment is an
  advantage

Technical Skills

• Understanding of drug product processes
  (e.g., liquid formulation, oral solid dose, fill/finish).
• Knowledge of cGMP and regulatory
  expectations (FDA, EMA, ICH).
• Familiarity with:
• • Technology transfer and
    validation processes
  • Deviation, CAPA, and
    change control systems
• Strong data analysis and technical
  writing skills.

Key Competencies

• Communication skills with both internal
  & external partners.
• Ability to work independently in a
  virtual, matrixed environment.
• Critical thinking and problem-solving
  capability.
• High attention to detail and
  compliance-driven mindset.
• Organizational skills to manage multiple
  CDMO activities simultaneously.

Preferred Qualifications

• Experience working directly with CDMOs or
  in a virtual pharma model.
• Knowledge of sterile/aseptic processing
  or biologics drug product.

Working Conditions

• Primarily office-based
• Regular interaction with global CDMOs
  across different time zones.

Career Progression

• MS&T Senior Associate / Scientist
• Technical Lead (External Manufacturing)
• CMC / MS&T Project Manager