Summary of the role
As the Technical Manager, Commercial Products, you are directing commercial product support activities. The Technical Manager is responsible for coordinating the direction of process performance monitoring and identifying and leading process improvements. The Technical Manager directs their team on the execution and gaps associated with the control strategy, process design, and unit operation and equipment support while ensuring appropriate communication and partnership with the key stakeholders external to the technical team (e.g., production, EH&S, QC, and QA). The incumbent will play a key role in external communication with the customer in support of the Partnership Manager and is responsible for the collaborative development and performance of the technical team members. The Manager ensures a high level of execution during the manufacturing phase of the program, in alignment with the deliverables in the contract, and providing a high level of intrinsic value addition to the product.
Requirements for the role
- Leads planning and technical support for execution of commercial product production.
- Ensures that the product documentation and deliverables are kept up-to-date with the relevant data pertaining to regulatory status, process performance, supply chain and production activities.
- Is responsible for the scientific substance of processes, ensuring accountability of team members to functional standard work deliverables as well as their integration with other technical functions.
- Embraces and develops a culture of innovation for the purpose of adding value to the commercial portfolio.
- Owns the change management process for the introduction of process improvements and gap remediation on the commercial product portfolio.
- Leads the technical team in execution of investigations, continuous process verification protocols, reports, and reviews.
- Works closely with the manufacturing organization to identify improvements and provide support from the production engineering and support chemistry teams.
- Leads technical initiatives cross-functionally to improve the right-first-time execution of production campaigns; identifying and reducing sources of variation and risk.
- Works closely with Regulatory and CMC functions to evaluate potential impact of proposed changes.
- Coordinates the generation of updates, reports, protocols and governance packages, ensuring scientific and executional accuracy.
- Leads technical writing team in the planning and execution of quality document (e.g. Master Production Record) creation and associated template creation, updates, and templates to drive consistency, quality and executability.
- Ensures appropriate technical and product escalation occurs when needed.
- Participates in meetings by video chat or by telephone ("telecons") with customers.
- Ensures readiness of development outputs (materials, technical documents and work plans) and drives deliverables with the team for manufacturing readiness (STR's, MPR's, MACO's, materials, methods, etc.).
- Ensures that production campaigns (if required) are supervised by the technical team.
- Is the primary contact for customers and auditors concerning the scientific aspects of products.
- Contributes to project technical evaluations for the purpose of product costing evaluation for commercial supply agreements.
- Directly leads team of approximately 3 - 7 direct reports.
- Participates in the hiring process of other employees.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring, and performance management.
- Embodying our company values, which are: be reliable, be caring, be transparent and be willing.
What we offer
- Bachelor's Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required.
- Master's or Doctorate Degree preferred.
- 5-7 years of related experience required; 12+ years preferred.
- Prior pharmaceutical experience required; prior CDMO experience preferred.
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
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