Technical Services Manager

Responsibilities

• Lead the preparation, review, and approval of technical documentation including validation protocols/reports, master batch records, SOPs, and technical transfer dossiers in accordance with cGMP requirements.
• Oversee process validation and technical transfer activities for oral solid dosage manufacturing, ensuring robust documentation and regulatory alignment.
• Manage change control activities related to manufacturing, packaging, and engineering systems, ensuring thorough impact assessment and timely execution.
• Provide leadership, coaching, and development to Technical Services staff to ensure high-quality deliverables and balanced workload distribution.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and R&D to resolve technical issues and maintain documentation readiness.
• Drive continuous improvement initiatives to strengthen data integrity, streamline documentation workflows, and enhance departmental efficiency.

Requirements

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline required; Master’s degree preferred.
• 8–10 years of progressive experience in technical services, process validation, documentation, or manufacturing support within an oral solid dosage pharmaceutical environment.
• Minimum 3–5 years of leadership or supervisory experience managing technical or documentation-focused teams.
• Strong understanding of process validation, technical transfer, and change control systems in compliance with FDA, ICH, and USP standards.
• Proven technical writing and documentation management skills with a focus on clarity, accuracy, and compliance.
• Familiarity with document control systems (e.g., MasterControl) and data integrity expectations under cGMP.
• Excellent organizational, communication, and project management abilities, with the capacity to lead cross-functional initiatives.
• Certifications in Lean, Six Sigma, or Project Management preferred.

Qualifications

We are looking for applicants with:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline required; Master’s degree preferred.
• 8–10 years of progressive experience in technical services, process validation, documentation, or manufacturing support within an oral solid dosage pharmaceutical environment.
• Minimum 3–5 years of leadership or supervisory experience managing technical or documentation-focused teams.
• Strong understanding of process validation, technical transfer, and change control systems in compliance with FDA, ICH, and USP standards.
• Proven technical writing and documentation management skills with a focus on clarity, accuracy, and compliance.
• Familiarity with document control systems (e.g., MasterControl) and data integrity expectations under cGMP.
• Excellent organizational, communication, and project management abilities, with the capacity to lead cross-functional initiatives.
• Certifications in Lean, Six Sigma, or Project Management preferred.

Skills

• Leadership and coaching skills
• Collaboration across functional areas
• Process validation and technical transfer expertise
• Data integrity and documentation management proficiency
• Project management and continuous improvement mindset

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays