Pillar5 Pharma is seeking a Manager of Technical Services to lead the technical formulation and process initiatives that support commercial manufacturing of ophthalmic sterile drug products. This includes new production introduction, lifecycle changes, and resolution of complex formulation-related issues. Reporting to the Director, Technical Services and Projects, the Manager of Technical services will also lead product exits and other technical support requirements, as required.
Key Responsibilities:
Formulation Leadership
- Serve as the site subject matter expert, along with technical service specialists, for ophthalmic drug formulations, with particular focus on sterile liquid dosage forms, preservative systems, viscosity-modified formulations, excipient compatibility, stability, and manufacturability.
- Lead formulation-related process development and scale-up activities to ensure new and existing Clear Eyes products can be compounded and manufactured consistently in a commercial environment.
- Lead and assess formulation risks and recommend scientifically sound solutions related to bulk hold times, filtration, mixing, pH adjustment, osmolality, clarity, and fill performance.
Technical Transfer and Commercialization
- Lead successful technical transfer and commercialization of new Clear Eyes products, re-launches, andadditionalSKUs, while aligning priorities with internal and external stakeholders.
- Act as the technical bridge from new product development (NPD) to commercial production teams, translating formulation intent into practical manufacturing execution.
- Develop batch parameters, process instructions, and manufacturing instructions for all new product introductions and transferred products.
- Execute or lead trial, engineering, and stability batchesrequiredto support formulation scale-up, process confirmation, and launch readiness.
Manufacturing Support and Troubleshooting
- Support Operations in troubleshooting formulation-related manufacturing issues and lead structured investigations into process deviations, yield losses, physical instability, or compounding challenges.
- Partner with Engineering and Operations to define equipment and process requirements needed to manufacture ophthalmic formulations effectively and compliantly.
- Provide technical leadership in root cause analysis, CAPA development, and change management associated with formulation or process changes.
Validation, Compliance, and Documentation
- Work closely with Validation and PMO teams to align project priorities, technical transfer activities, and validation deliverables.
- Support validation strategies and technical assessments for formulation, process, cleaning, and related manufacturing changes, ensuring GMP and regulatory compliance.
- Collaborate with Quality Operations tomaintaincompliance and ensure technical decisions are properly documented and justified.
Customer, Supplier, and Cross-Functional Support
Compensation:
$110,000.00 - CA$135,000.00 per year
Benefits:
- Company events
- Company pension
- Disability insurance
- Discounted or free food
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
- Wellness program
This posting is for an existing vacancy. Pillar5 Pharma does not use AI at any stage of the recruitment or hiring process. Pillar5 Pharma is committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request throughout the recruitment and selection process