SVP, Technical Operations

US-MA-Bedford
2 months ago(10/16/2017 2:43 PM)
Job ID
2017-1029
# of Openings
1
Category
Operations

Overview

Responsible for directing activities for new product introduction and marketed product support, including contract manufacturers. Responsibilities involve ensuring successful transfer of new products from R&D into commercial manufacturing as well process optimization activities for marketed products. The incumbent will foster effective cross-functional working relationships with internal and external groups. The incumbent will apply innovative manufacturing technology and quality-by-design principles and execute on key strategic operations projects to achieve business objectives. The incumbent will provide support to contract manufacturers for scale-up, process validation, and continuous process monitoring for marketed products. The incumbent will support on the floor manufacturing activities, deviation, change control and CAPA, as well as support regulatory submissions.

Responsibilities

•Collaborates with formulation scientists and scale-up teams to ensure optimal process development and application of QbD principle
•Work closely with Business Development, Research & Development, Manufacturing, Engineering, Regulatory Affairs and Quality Assurance teams
•Harmonize business processes across the technical organization implementing best practices accordingl
•Identify and execute on manufacturing improvement/COGs reduction projects
•Responsible to ensure that plant objectives are aligned with both Quality, Supply Chain, and the Business Unit objective
•Communicate with senior management and site leaders to identify and resolve any technical issues
•Accountable for managing site specific financial plan for technical operations department
•Ensures adherence to cGMP’s, standard operating procedures, safety practices and manufacturing protocols. Ensures the safety of all Manufacturing Operations employees through compliance with all company policies, procedures, safety rules, and regulations
•Accountable for ensuring that standard operating procedures are established and executed in accordance with all regulatory requirements and best practice
•Accountable for leading Continuous Improvement initiatives, utilizing expert resources to reduce overall cost of goods, manufacturing cycle times, and all forms of waste. Applies Process Excellence methodologies (6 S, Lean Manufacturing, and Six Sigma) to improvement initiative
•Provides guidance in regulatory and internal audits and inspections. Ensures team members respond to audit observations and make timely and appropriate corrective action
•Responsible for ensuring that training and development programs for staff members are in place to meet future objectives of the business. Participates in Talent Management, succession planning, and talent acquisition

Qualifications


•Minimum of a Bachelor's degree in Engineering, Life Sciences and/or Business.  Advanced degree a plus
•Must possess knowledge of cGMPs and SOPs applicable to position. 21CFR Part 210 and 211 and Part 11
•Strong knowledge, understanding and demonstrated experience in Supply Chain Operations, including inventory management, planning, scheduling and all associated measures and metrics
•Experience in technical development (transition from clinical trial production to commercial production)
•Polymer formulations experience
•Experience leading production units through FDA and EMA inspections
•Knowledge and understanding of pharmaceutical manufacturing, compounding, production processes, and packaging operations, equipment and facilities
•Knowledge of Standard Work Principles and demonstrate the ability to implement standard work in a visual factory environment
•Knowledge of statistical and mathematical principles
•Knowledge and demonstrated application of Process Excellence tools (6S, Visual Factory, Lean Manufacturing and Six Sigma) and methodologies
•Basic knowledge of computer programs. Background knowledge in pharmaceutical science or engineering is advantageous
•Must possess good interpersonal skills, effective verbal and written communication skills and demonstrate strong collaboration capability
•Must demonstrate the ability to multi task
•Experience with formulation and process development of oral solid-dosage, liquid, creams, ointments and other dosage forms is required
•This role will require a minimum of 50% travel

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed