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.
Qualifications and Requirements:- Post secondary degree in Science, Engineering, or a related field.
- A minimum of 7 years' experience in a manufacturing environment and proven project management skills
- Demonstrated experience and knowledge of Technical Transfer programs, product launch requirements, process development and regulatory aspects of (NPI) New Product Introductions.
- Thoroughly familiar with PM concepts and processes. Professional designation, PMP, is valued.
- Excellent organizational and time management skills
- Ability to work collaboratively within a team environment.
- Knowledge of pharmaceutical GMPs.
- Deep understanding of formulation principles for ophthalmic products.
- Direct experience in sterile manufacturing and aseptic processing is highly preferred; ophthalmic eye drop experience is a significant asset.
- Strong oral and written communication skills, including listening skills.
- Experience in technical writing, statistical analysis, root cause analysis and problem-solving techniques.
- Proficiency with MS Office (Word, Excel, Project, PowerPoint)
Compensation:$110,000.00 - CA$135,000.00 per year.
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, and additional SKUs, 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 batches required to 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 to maintain compliance and ensure technical decisions are properly documented and justified.
Customer, Supplier, and Cross-Functional Support
- Represent Technical Services in interactions with customers and brand partners, ensuring technical expectations are aligned with site capabilities and compliance requirements.
- Evaluate supplier-initiated changes in components or materials for impact on formulation performance, product quality, and validation requirements.
- Evaluate supplier-initiated changes in components or materials for impact on formulation performance, product quality, and validation requirements.
- Support innovative growth opportunities in ophthalmic products, including development of tailored manufacturing processes for new opportunities within the Clear Eyes portfolio and related ophthalmic programs.
- Team Leadership
- Lead and develop Technical Services team members, including Technical Specialists and Project Managers, in achieving annual goals and technical project deliverables.
- Build department objectives and budgets aligned with site goals and strategic direction.
- Lead and drive the department QMS KPIs, ensuring CAPAs, CCs, Deviations and Temporary Change Controls are completed on time.
- Mentor team members in formulation science, technical writing, problem solving, and cross-functional project execution.
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
