Director, Technical Services

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the technology transfer of new products, formulations, and processes into and between sterile and nonsterile compounding, 503B, and peptide API manufacturing locations.

• Manage transfer protocols and reports, establishing critical process parameters, in-process controls, and acceptance criteria.

• Collaborate with R&D, Quality, and Operations to facilitate transitions into routine commercial production.

• Direct the multi-site cleaning validation program, including method development, worst-case grouping, sampling strategies, and acceptance-limit calculations.

• Author and implement cleaning validation protocols and reports while managing ongoing cleaning verification and monitoring activities.

• Lead process validation efforts for sterile and nonsterile compounded preparations, sterile manufacturing, and peptide API manufacturing.

• Own the network-wide process validation program, ensuring that site verification aligns with the validated state.

• Identify and resolve process deviations, yield losses, quality challenges, and equipment performance issues across four sites.

• Spearhead root-cause investigations, Corrective and Preventive Actions (CAPAs), and continuous improvement initiatives.

• Assist with equipment commissioning, qualification, start-up troubleshooting, and reliability enhancements.

• Establish network-level strategies and standards for process development scale-up, capital equipment installation, and Equipment Installation/Operational Qualification/Performance Qualification (IOQ/PQ) execution.

• Review and authorize site IOQ/PQ and requalification protocols.

• Monitor requalification schedules and change-control triggers.

• Lead, coach, develop, hire, onboard, and plan career advancement for site Technical Services Managers.

• Create network-wide technical standards, training, and knowledge-sharing platforms.

• Engage in FDA and state board of pharmacy inspections as a technical subject matter expert.

• Provide inspection documentation and assist with technical responses to observations.

⛳️ Requirements

• A Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical/scientific field is required; an advanced degree is preferred.

• A minimum of 12 years of progressive experience in pharmaceutical manufacturing or sterile/nonsterile compounding.

• Direct, hands-on experience in technology transfer, cleaning and process validation, or troubleshooting processes/equipment.

• Proven expertise in at least two areas: 503A/503B compounding operations, sterile injectable manufacturing, and API/peptide manufacturing or process chemistry.

• Familiarity with USP standards.

• Knowledge of FDA's Process Validation Guidance (2011).

• Understanding of ICH Q7/Q11 guidelines for API manufacturing.

• Strong experience in root-cause investigation and CAPA.

• Experience in resolving process and equipment issues within a regulated manufacturing environment.

• Ability to collaborate across geographically distributed sites, including remote team engagement and site travel.

• Excellent technical writing skills.

• Proficient in producing and reviewing technology transfer, cleaning validation, and process validation protocols and reports.

• Previous experience managing or developing managers/supervisors in a multi-site or matrixed manufacturing organization.

• Preferred experience in peptide, oligonucleotide, or other complex API manufacturing and related technology transfers.

• Hands-on troubleshooting experience with autoclaves, isolators, filling lines, or API processing/purification equipment is preferred.

• Experience in supporting new equipment commissioning or site launch initiatives is preferred.

• Prior participation in FDA inspections, including front-room or back-room technical support, is preferred.

• Legally authorized to work in the U.S. without any restrictions for any employer.

🏝️ Benefits

• Competitive salary.

• Equity compensation.

• Unlimited Paid Time Off (PTO).

• Company holidays.

• Quarterly mental health days.

• Medical, dental, and vision benefits.

• Parental leave.

• Employee Stock Purchase Program (ESPP).

• 401(k) with employer matching contributions.

• Offsite team retreats.

• Flexible/remote work options.