Softworld Senior Manufacturing Operations Consultant in Waltham, Massachusetts

Senior Manufacturing Operations Consultant

Waltham, MA

| Contract

Post Date: 03/12/2018

2018-03-12 2018-04-20

Job ID: 225850

Industry: Life Sciences

Job Description

Senior Manufacturing Operations Consultant:

Key Responsibilities:

· Providing subject matter expertise relative to technical aspects of solid dosage API and drug product manufacturing operations

· Continual scrutiny of manufacturing operations to identify, assess, and implement opportunities for process optimization

· Review and approve applicable product batch manufacturing documentation, including batch records, testing data, change controls and deviations

· Manage projects relative to API and drug product process improvements, scale-ups, and similar development activities at CMOs.

· Participate on new product process development teams as a key technical contributor

· Participate on technical transfer teams as a key technical contributor

· Lead efforts in partnership with Process Development and Quality Assurance to identify potential contract manufacturing options for both existing, and new, products

· Monitor and manage costs associated with manufacturing operations, assess opportunities for cost improvement projects

· Provide CMO relationship management and/or oversight to contract manufacturing operations

· Author, and/or contribute to creation and/or revision to, regulatory filing sections related to commercial manufacturing operations

· Partner with Process Development personnel during definition, documentation, and completion of process validation activities for new products at contract manufacturing facilities

· Participate on due diligence teams relative to potential new contract manufacturing sites

Required Skills:

· 10+ years pharmaceutical manufacturing experience, preferably in solid oral dosage API and drug product operations

· Bachelor’ s degree in an Engineering, Chemistry, or equivalent discipline required

· Master’ s degree in an appropriate technical discipline desired

· Knowledge of pharmaceutical contract manufacturing required

· Prior experience with manufacturing scale-up and technical transfer projects, as well as new product launch activities, desired

· Familiarity with Lean Six Sigma practices desirable

· Domestic / international travel up to 25%

· Demonstrated project management capability

· Proficiency with MS Office applications; advanced knowledge of Excel and MS Project desired

· Proven ability to work with a high level of integrity, accuracy, and attention to detail

· Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.

· Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.