The Manager, MS&T (Remote - East Coast) is focused on projects involving devices or device-based technologies, the new role will be part of a team of technical experts that work with external vendors or CMO’s to deliver projects exiting from the R&D space that need to be successfully deployed into a commercial setting and commercial projects that involve lifecycle management or process improvements. The role will include over-site of product scale-up, process optimization, technology transfer and equipment validation.

Essential Functions

• Accountable for end-to-end technical support of Externally Manufactured Products to ensure on time product supply.
• Collaborate with key stakeholders, suppliers, and customers to ensure processes are reliable and meet Operational needs.
• Establish partnerships with vital stakeholder departments to ensure timely sharing of information and a collaborative approach to problem solving and process improvement and the application of lean manufacturing techniques to continuously improve cycle times and process flows.
• Provide technical input & assist in validation activities associated with qualification projects while making sure that all issues and trends both internally and site-wide are critically evaluated.
• Review and provide strategic input to process-related investigations, product impact assessments, Change Control assessments, CAPA completion and raw material changes.
• Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols.
• Provide technical support for investigations and lend expertise in problem solving activities on existing production activities, determining root cause and corrective actions.
• Manage / execute the equipment validation for new and existing products
• Lead / support process improvement projects, including new technology.
• Coordinate and oversight of engineering projects at CMO for existing and new products.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Higher degree in Engineering/Science required, with 5 plus years of related industry experience in drug/combination product manufacturing.
• Demonstrated experience managing Contract Manufacturing Organizations.
• Thorough knowledge of quality systems, Quality by Design, validation, design transfer, and quality engineering principles for devices and combination products
• Strong oral and written communication skills, enabling clear messaging that provides explanation and sets a clear path forward, responding to questions openly and adjusting the message for the audience and forum
• Knowledge of late-stage development including pre-validation activities (small scale manufacturing model qualification, process optimization, risk-based approach to FMEA, process characterization). Matrix based experimental design is required and experience with DOE highly desirable.
• Knowledge of ICH guidelines including Q7, Q8, Q9, and Q11 and US FDA process validation guidelines.
• Experience with Project Management tools an advantage

Job Type: Full-time

Pay: $110,455.67 - $145,462.73 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Signing bonus

Work Location: Remote

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